Dendreon...mit Provenge das erste Vaccin zur Krebstherapie? - 500 Beiträge pro Seite (Seite 17)

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.788.021 von edelupolino am 07.07.10 15:00:47

Ich hoffe Du hast Recht und mir ist das Wichtigste, daß den totkranken Männern geholfen werden kann, Kohle hin oder her!

[GuHu1]

Antwort auf Beitrag Nr.: 39.786.870 von Magnetfeldfredy am 07.07.10 11:51:14

könnte sein das du mal wieder ein perfektes timing hattest.
anbei mal ein lesenswerter beitrag aus dem IV (saulk).

http://seekingalpha.com/instablog/567205-saulk/80523-dendreo…

[zwitscherton]

Antwort auf Beitrag Nr.: 39.794.580 von GuHu1 am 08.07.10 17:09:40

Das sieht wohl ganz danach aus ...

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.794.580 von GuHu1 am 08.07.10 17:09:40

Man weiß nie wann oben oder unten ist bei einer Aktie, aber bei Dendreon gehe ich bei einer Übernahme die täglich, stündlich kommen kann von mindestens 50 US Dollar aus!
Langfristig kann DNDN dreistellig werden!

Aber auch 20 US Dollar sind drin wenn`s schlecht läuft!

Sein "Baby" gibt man nicht gerne her!

[glaubehoffnung]

Antwort auf Beitrag Nr.: 39.800.715 von Magnetfeldfredy am 09.07.10 17:28:57

Mädels, es gilt DNDN Adieu zu sagen, schaut euch die potenzielle Konkurrenz NWBO an, sieht doch vielversprechend aus!

http://www.investmentu.com/2010/July/danger-ahead-for-dendre…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.822.725 von glaubehoffnung am 14.07.10 22:17:42

Deine OB Klitsche wird schon lange nicht mehr am Markt sein wenn Dendreon seinen nächsten Blockbuster, Neuvenge, auf den Markt bringt!

[MrBean07]

Antwort auf Beitrag Nr.: 39.788.565 von Magnetfeldfredy am 07.07.10 16:10:31

mir ist das Wichtigste, daß den totkranken Männern geholfen werden kann

So ein scheinheiliger Blödsinn, das wichtigste ist dir die Entwicklung deiner Dendreonaktien, laber hier nicht so einen Stuss

[GuHu1]

Antwort auf Beitrag Nr.: 39.823.389 von MrBean07 am 15.07.10 08:29:27

na im scheiß labern bist du doch die nummer 1, denke nur an deine kursziel in 2009 von $0,1

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.823.389 von MrBean07 am 15.07.10 08:29:27

Du bist nur ein ein: Looooooooooooooooooooooooosssssssssssssssssseeeeeeeeeeeeeerrrrrr!

[NoSelters]

Antwort auf Beitrag Nr.: 39.822.725 von glaubehoffnung am 14.07.10 22:17:42

Na du "Gläubiger".

Schon wieder auf was reingefallen?

NWBO ist so gut wie tot.

Guckst Du hier...( Saul's Blog)
http://seekingalpha.com/instablog/567205-saulk/81541-lessons…
Weiterhin ne gute Nase...,


DNDN Loooong.....

[glaubehoffnung]

Antwort auf Beitrag Nr.: 39.826.839 von NoSelters am 15.07.10 16:34:01

@Selters, bin doch nicht reingefallen, hab netto 400x % mit DNDN gemacht. Bin nur auf Nummer sicher ausgestiegen, etwas unter dem momentanen Preis, der meiner Ansicht nach immer noch nicht Preis-Leistung angemessen abbildet.

Und DU kommst jetzt mit Basher-Zeugs, genau doch das Gedöns, das jahrelang gegen Provenge geschrieben wurde? Glaubste doch selbst nicht.
Wer von den DNDN-Recken seine Sinne beisammen hat, geht nach DNDN in NWBO. Wenn Zulassung erfolgen sollte, winken wahnsinnige Chancen.

Nur zur Erinnerung Median Survival in Phase I + Phase I/II 36.4 Monate !!!,
nachzulesen hier: http://www.investmentu.com/2010/July/danger-ahead-for-dendre…

Noch was: http://finance.yahoo.com/news/Best-Cancer-Vaccine-Answer-iw-…


P.S.: Kann mal jemand das unqualifizierte Magnetfeld-Geblubber abstellen?

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.827.920 von glaubehoffnung am 15.07.10 19:01:34

Ich blubbere weiter so lange ich will und wer halt nur 400 % anstatt 1000 % gemacht hat wird leicht neidisch!

Außerdem starb mein Opa an Prostatakrebs und ich freue mich für jeden Erkrankten, daß es Provenge gibt Du A......

[glaubehoffnung]

Antwort auf Beitrag Nr.: 39.827.920 von glaubehoffnung am 15.07.10 19:01:34

Nachtrag: Hättet ihr auf meinen gestrigen NWBO-Tip gehört, hättest ihr heute 30% machen können.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.826.839 von NoSelters am 15.07.10 16:34:01

Servus No,

laß Ihn doch, der soll mit NWBO schön auf die Freße fallen, verdient hätte er es!

[MrBean07]

Antwort auf Beitrag Nr.: 39.824.650 von GuHu1 am 15.07.10 11:36:12

denke nur an deine kursziel in 2009 von $0,1


Ach du lieber Uhu, dieses Ziel ist noch nicht vom Tisch, fragt sich nur wann das sein wird!

[GuHu1]

http://www.minyanville.com/businessmarkets/articles/dendreon…
Dendreon's Provenge Costs the Same as Chemotherapy

When Dendreon (DNDN) surprised Wall Street by choosing a price for Provenge of $93,000, it was inevitable much of the conversation about Provenge going forward would revolve around price.

When the Centers for Medicare Services (abbreviated CMS) dove in and launched a National Coverage Assessment (shortened to NCA) for Provenge, this really got the debate about Provenge’s price moving. In retrospect, the NCA process makes sense as CMS most likely wants to make sure it's not paying for off-label use of the drug.

The outcome of the Provenge IMPACT trial was reported yesterday in the New England Journal of Medicine. As is usually the case with important new and/or first-in-class drugs, the publication included an editorial by Dr. Dan Longo, an immunologist working for the National Institute of Aging. The editorial had its positive parts, with Longo concluding a review of the IMPACT trial by stating:

"Thus, a 23% reduction in the risk of death in patients with metastatic disease is an important step.”

However, Longo put forth three criticisms. The first two are trial/science geek stuff, which my firm (Biotech Stock Research) and I don't think hold water. The third criticism was related to Provenge’s cost. Longo states:

“Another concern with sipuleucel-T treatment is the cost. The current cost of care for men with prostate cancer has been estimated to be about $1,800 per month. (Alemayehu, 2010) The manufacturer has set the cost of a 1-month course of sipuleucel-T at $93,000, or $23,000 per month [sic] of survival advantage.”

The problem here is that Longo’s math is wrong and the Alemayehu study he chose to cite used methodology that makes it unusable for drug-to-drug cost comparisons. (On a side note, Longo also errs in assuming Provenge has a 4.1-month survival advantage. It doesn’t. It has a 4.1-month median survival advantage. The best way to understand the difference is to read Stephen Jay Gould’s essay "The Median Isn't the Message”.)

Let me explain to two big flaws in Longo’s cost math:

The Alemayehu cost data come from a retrospective study of patients between 2001 and 2007. The lead author of the paper is an employee of AstraZeneca (AZN), a Dr. Berhanu Alemayehu. I note the cost estimates from his paper for the “treatment” of CRPC are far lower than other data I’ve seen. This made me dive into the study methodology. Here’s what I found:

The methodology of the paper would have captured patients who chose no therapy for CRPC. While this isn't an incorrect methodology, data generated can't be used to compare the cost of drugs to one another because non-treatment is included.

The paper only covers pharmacy costs for Taxotere (Sanofi-Aventis' (SNY) chemotherapy that was approved in 2004 for prostate cancer) and hormone therapy drugs. Drugs used to treat side effects were counted only if prescribed by a urology or oncology practice. This ignores drugs used to treat acute side effects at the emergency room level. It also ignores radiation therapies.


The study ignores the fact that Taxotere wasn’t even approved in three of the seven years he studied.

Costs, both from hospital visits and the pharmacy, were included only when cancer was listed as the primary treatment item. This serves to underestimate overall costs by emphasizing differences in coding practices and ignoring treatments a physician felt were related to cancer therapy, but cancer was listed as a secondary item.

The big problem is the first one. Anywhere from 50%-75% of men with CRPC choose not to use chemotherapy. By including that population in the cost figures, the Alemayehu paper is unsuitable for use for cost comparisons. Using it essentially means you're comparing the cost of no therapy to the cost of therapy.

That’s hardly a fair comparison.

Compounding the flaw in his choice of a reference paper, Longo also incorrectly calculated his cost figures. He uses the raw $1,800 PPPM figure and compares it to Provenge’s per median survival month figure. In simpler terms, he uses a monthly cost figure without converting it to a therapy cost figure.

The following table uses data from the Alemayehu paper, numbers from a more complete analysis of chemotherapy costs from the Milliman firm, and actual Provenge costs to place the cost analysis in proper perspective.



I reiterate, the Alemayehu paper is inappropriate for cost comparisons because a substantial number of patients it tracks chose no therapy for CRPC. Comparing the cost of Provenge (or any other therapy, for that matter) against the cost of doing nothing is hardly fair or accurate. I included the Alemayehu column only to illustrate where Longo made his second error.

I should discuss the Milliman data briefly. The report wasn't specific to prostate cancer, but included prostate cancer as a separate data set. It looked at chemotherapy costs across a wide variety of cancers. The data were generated off a very large insurance database. Unlike the Alemayehu paper, it focused only on patients treated with chemotherapy and excluded those who didn't make that choice. It captures more side effect cost data by using primary and secondary codes for cancer/chemo-related treatments whereas the Alemayehu paper used only primary. The Milliman analysis does exclude patients over 70, which I believe likely underestimates the true cost of chemotherapy side effects since all the data I've seen shows people over 70 have higher and more severe side effects to Taxotere. The Milliman analysis doesn't make any attempt to segregate chemo use in CRPC from chemo use in earlier-stage disease. I don't believe this can account for the marked difference in cost PPPM compared to the Alemayehu since chemo is rarely used in earlier-stage prostate cancer (unlike almost all other cancers).

Most likely, the majority of PPPM cost differences between the Milliman analysis and the Alemayehu paper result from Alemayehu’s methodology that captures “no-cost” patients who declined to receive chemotherapy for CRPC. It's worth repeating that this is a majority of patients, somewhere between 50% and 75% depending on the analysis. This choice doesn't represent a flaw in Alemayehu’s methodology, but does mean the paper is unsuitable for use in comparing treatment costs.

I remain unconvinced calculating cost per median month survival is an effective method of cost comparison. Even though the table above shows the monetary cost of Provenge is comparable to the monetary cost of chemo in prostate cancer patients, this analysis ignores the radical difference in quality of life. I summarize a few of these quality-of-life differences in the table below.



Provenge is priced equivalent to the inclusive monetary cost of chemotherapy according to the Milliman data. This is somewhat ironic given the recent focus on Provenge’s “high” cost. When one looks at even the brief side effect comparison I show above, it’s easy to see why men are clamoring for Provenge and why the majority refuse to take Taxotere. It should also be easy to see why simple comparisons of monetary cost don’t represent the entire difference between two therapies.

[GuHu1]

Antwort auf Beitrag Nr.: 39.827.920 von glaubehoffnung am 15.07.10 19:01:34

als weiser und vorsichtiger anleger solltest du OTC buden entsprechend bewerten.
ich erinnere hier nur an novelos (lungenkrebs, zugelassen in Russland) welche großartige aussichten meldeten um dann in phase III völlig zu versagen!

wenn du seriös wärst, würdest du das dem kleinanleger, der hier liest so auch sagen!
also viel erfolg mit nwbo.

[GuHu1]

hier der link zur öffentlichen CMS diskussion bzgl. kostenübernahme....



http://www.cms.gov/mcd/viewpubliccomments.asp?nca_id=247

[GuHu1]

http://abcnews.go.com/Health/ProstateCancerNews/cancer-vacci…

Provenge Cancer Vaccine: Can You Put a Price on Delaying Death?
Revolutionary Drug May Cost $93,000 to Add Four Months to Life for Prostate Cancer Patients

115 comments By COURTNEY HUTCHISON, ABC News Medical Unit
Jul. 29, 2010

With the advent of Provenge, the first-ever vaccine cancer treatment, that tag has been set at about $23,000 per month of life gained -- $93,000 in total for a treatment that extends life, on average, by four months.

Given already skyrocketing health care costs, the nearly-six-figure cost of Provenge has raised concerns among health care experts, but to those men who have benefited from this revolutionary new therapy, it's worth every penny.

"On a general basis, to survive is worth anything," says Bob Feutz, 84, of Redmond, Washington.

Feutz received Provenge in 2007 as part of a clinical trial after other hormone therapy and 38 sessions of radiation failed to control his prostate cancer adequately.

Provenge, unlike his radiation treatments, caused him nearly no side effects, just two short bouts of chills, during the three sessions needed. While his PSA level -- a test that helps gauge the presence of prostate cancer -- was over five before treatment, in the three years since it has steadily dropped to .69.

Related
Waiting Game for Life-Extending Prostate Drug FDA May Approve 'Revolutionary' Cancer Vaccine FDA OKs Vaccine Therapy for Prostate Cancer"I'm happy to be alive," he says.

Frank Notaris, a 77-year-old Brooklyn native, feels the same way. He just went through treatment a few months ago, but says that "if it keeps you alive, I think it's absolutely worth the cost. Hopefully the insurance companies will cover it."

But given the skyrocketing cost of health care, that cost, multiplied by the thousands of patients each year who could qualify for the treatment, raises concerns for some health policy experts.

The revolutionary technology responsible for the first vaccine for cancer treatment was 15 years in the making, says Mitchell Gold, president and CEO of Dendreon, the company that produces Provenge.

"It was a laborious process. We had to raise $1.2 billion to support the development. I think we've come up with a price that's acceptable. It's priced fairly for the value we're providing to the patients."

Gold says that the cost of Provenge was based on the "overall landscape" of treatment prices for cancer. More specifically, the comparable chemotherapy for advanced stage prostate cancer patients, Taxotere, ends up costing about $23,000 per month of life extended by the treatment.

This was used, in part, to set the price of Provenge -- four months, on average, of extended survival comes out to about the $93,000 price tag.

Provenge for Prostate Cancer: Life at Any Price?
Given that Provenge only takes three sessions of treatment over the course of a month, and causes few side effects, Gold says it provides "increased value" when compared to chemotherapy, which takes months and causes fatigue, nausea, and other side effects.

But does setting the price on par with other similarly costly cancer treatments make it a "fair" price?

Related
Breaking Up Is Hard to Do ... for MenCan Real Men Admit They're Depressed?Dissatisfied Husbands More Likely to Die of Stroke"Fairness has nothing to do with it," says David Howard, assistant professor in the department of Health Policy and Management at Emory's Rollins School of Public Health.

Because cancer treatment is usually covered by insurance, not the patient, pharmaceutical companies don't have to answer to the budgets of consumers when pricing.

"If they charge a million dollars that might be so ridiculous that it wouldn't be covered, but otherwise they have a pretty broad range," Howard says. This is one reason there has been a gradual uptick in the price of cancer treatments, he says.

Every year, a "ridiculous" price for a new treatment comes out, and "it's high but in the same ballpark as last year's high-priced treatment. It's an upward ratcheting of what's the maximum acceptable price," Howard says.

And while patients don't normally have to answer to this price, health insurance companies and Medicare do.

An estimated 200,000 new cases of prostate cancer will be diagnosed in 2010, according to the National Cancer Institute. While only a fraction of these cases will ever become eligible for treatment with Provenge, the potential burden on Medicare funds is sizable.

Currently, Medicare is not allowed to deny a treatment based on cost alone, but in the coming years, "it will be difficult to sustain coverage of these very costly procedures considering the Medicare program is facing a huge long-term deficit," Howard says.

"Ten years, 20 years down the road, Congress is going to have to rewrite the law to allow cost to play into coverage decisions."

Medicare Decisions, Future Coverage
While some local Medicare providers already cover Provenge, Medicare nationally will be taking a year to review the product before offering it unilaterally, a caution that Howard says is most likely due to the high cost.

But while $93,000 for four months of treatment seems like a lot, the benefit provided to patients and the revolutionizing technology brought to the fore by Provenge makes it worthwhile, says Dr. Anna Ferrari, professor in the Department of Medicine at NYU Langone Medical Center.

Related
Too Many Cancer Tests Yield False PositivesProstate Screening: What Should You Do?Should You Get Cancer Screenings?Chemotherapy kills cells new cells in the body in order to attack cancer cells. But Provenge works by boosting the patient's own immune system and training it to attack invader cancer cells specifically.

Provenge was approved by the FDA for use in patients with advanced, hormone therapy-resistant prostate cancer in April, following the positive results of a study Ferrari co-authored.

That study, published in the New England Journal of Medicine Wednesday, found that, on average, patients taking Provenge survived 4.1 months longer than those who took a placebo, and did so with significantly fewer side effects than normally seen with chemotherapy or radiation treatments.

The treatment is custom-made from a patient's own blood. The patient's immune system factors are mixed with an immuno-boosting agent and prostate cancer-specific antigen that make up Provenge. The vaccine is then returned to the patient's body where it incorporates into the body's immune system.

This immunological attack on treating advanced cancer is groundbreaking Ferrari says, and "provides a completely new weapon for cancer, with minimum toxicity." It is a development that may lead to similar treatments for other common cancers, such as breast cancer, she adds.

"I'm very optimistic that this will open a whole new venue for cancer treatment with hardly any side effects," she says.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.908.482 von GuHu1 am 31.07.10 21:26:05

Servus GuHu1,

für mich ist und bleibt Dendreon eine Revolution in der Krebsbehandlung, jetzt ist die Frage, wird kostendeckend erstattet, wenn ja, ist Dendreon für mich die nächste Dendreon, falls nicht wird Dendreon seinen Weg gehen der aber holprig und sehr volatil werden wird!

[edelupolino]

Antwort auf Beitrag Nr.: 39.908.482 von GuHu1 am 31.07.10 21:26:05

Hi an alle, (besonders an GuHu wg des Artikels),
bei der Frage nach dem Überlebensvorteil eines Medikaments gibt es naturgemäß völlig verschiedene Positionen:
einerseits haben wir die überall erscheinenden "Sparapostel" oder noch schlimmer "Sparkommissare". Denen möchte niemand ausgeliefert sein -es kann aber wg schlechter Kassenlage so kommen.
Dann haben wir Patienten wie Herrn Feutz ("Feutz received Provenge in 2007 as part of a clinical trial"), der UNGLAUBLICHE Jahre durch dieses Medikament geschenkt bekam und selbstverständlich begeisterter Befürworter ist.
Wer dies als Betroffener liest, gibt keinen Deut auf die nur 4 Monate (wichtig ist hier "on average"!): jeder hofft, dass er länger, ja viel länger überleben wird als der statistische Durchschnitt. ("Shit" kann natürlich auch "happen")
Was aber kann man machen, wenn das Medikament nur von Großkopferten und Betuchten gekauft werden kann? ...junge Männer ab 30/35 sollten sich um eine Versicherung kümmern, die dieses Risiko wie auch immer abdeckt: jeden Monat ein paar Mäuse abdrücken, wem schadet das? Wir verbraten ja auch viel für Party-Party und Malle-Fliegen!!
Schönen Sonntag noch, aber nicht vergessen, Jungs: für die Zukunft planen!!!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.909.529 von edelupolino am 01.08.10 16:33:59

Servus Ede,

für mich ist ganz klar, die FDA hat grünes Licht gegeben, damit ist Provenge effektiv und sicher sonst hätte es keine Zulassung gegeben!
Was jetzt veranstaltet wird kommt von der Chemo-Lobby....., doch zuallerletzt wird Dendreon gewinnen bzw. hat schon gewonnen!

[glaubehoffnung]

Antwort auf Beitrag Nr.: 39.906.819 von GuHu1 am 30.07.10 22:29:56

Guhu,was soll denn diese blöde Formulierung???

"...wenn du seriös wärst, würdest du das dem kleinanleger, der hier liest so auch sagen!
also viel erfolg mit nwbo..."

Ich hab mich doch deutlich genug geäussert, und im Gegensatz zu vielen DNDN-Blubberern sachlich:

"...Wenn Zulassung erfolgen sollte, winken wahnsinnige Chancen..."
Ist doch wohl bei Biotechs auch grundsätzlich bekannt, dass mit Hochrisiko gefahren wird.
DNDN hat übrigens auch mal klein angefangen, die gleichen Sprüche, die ihr jetzt bringt, kamen damals auch von allen Seiten

Provenge ist nur der Einstieg, mehr nicht.
Die Wirkstoff-/Technik-Entwicklung muss deutlich bessere Überlebensdaten bringen, damit so was auch vom Preis her gerechtfertigt ist.

[GuHu1]

Antwort auf Beitrag Nr.: 39.909.614 von glaubehoffnung am 01.08.10 17:28:46

sei nicht gleich beleidigt, das risiko ist derzeit bei weitem höher als bei dndn nach den interims daten (2008).
sicher wenns gut läuft haste nen mega invest, das streitet ja auch keiner ab.

hi ede, gelesen?:

http://www.cms.gov/mcd/viewpubliccomments.asp?id=&cov_id=&st…

Commenter: Lichter, MD, Allen
Title: Chief Executive Officer
Organization: American Society of Clinical Oncology = ASCO
Date: 07/30/2010

[GuHu1]

http://www.healthscout.com/news/1/641551/main.html

[crivit]

Antwort auf Beitrag Nr.: 39.909.614 von glaubehoffnung am 01.08.10 17:28:46

nwbo = OTC Klitsche, mehr ist da nicht zu sagen!

[GuHu1]

Antwort auf Beitrag Nr.: 39.909.633 von GuHu1 am 01.08.10 17:38:00

http://www.cms.gov/mcd/publiccomment_popup.asp?comment_id=21…

oder als pdf:

http://www.accc-cancer.org/advocacy/pdf/2010_Comments_NCAPro…

[GuHu1]

Antwort auf Beitrag Nr.: 39.915.831 von GuHu1 am 02.08.10 21:55:11

tztztz

http://www.accc-cancer.org/advocacy/pdf/2010_Comments_NCAPro…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.915.840 von GuHu1 am 02.08.10 21:56:36

Ist schon traurig, daß nach der Zulassung immer noch so große Unsicherheit über Dendreon schwebt und wir wissen ja, die Börse haßt Nichts mehr als die Unsicherheit,hoffentlich wird morgen beim CC Tachiles geredet!
Meiner Meinung nach wird der Kurs erst wieder richtig abheben wenn die Zusage für die Kostenübernahme kommt und daß soll ja bis März 2010 dauern!

[GuHu1]

Antwort auf Beitrag Nr.: 39.915.953 von Magnetfeldfredy am 02.08.10 22:11:15

naja, bin ich mal gespannt, jerzee (iv) hat die comments "mitgeschnitten":

"The final tally on CMS' Comment page looks to be 642 entries with 26 negs (4 of which were added after the last update) along with 2 or 3 comments (of the total) which simply are difficult to determine what in the hell they're talking about .... "

http://www.investorvillage.com/smbd.asp?mb=971&mn=365001&pt=…

[GuHu1]

Antwort auf Beitrag Nr.: 39.915.953 von Magnetfeldfredy am 02.08.10 22:11:15

http://www.bloomberg.com/news/2010-08-02/dendreon-s-93-000-c…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.916.050 von GuHu1 am 02.08.10 22:30:35

Danke, daß baut auf!

[GuHu1]

http://www.xconomy.com/seattle/2010/08/03/dendreon-misses-wa…

Dendreon Misses Wall Street’s (Already Low) Expectations for Provenge Sales
Luke Timmerman 8/3/10
Dendreon, in its first two months on the market, sold a lot less of its groundbreaking drug for prostate cancer than analysts were expecting.

The Seattle-based biotech company (NASDAQ: DNDN) said it generated $2.81 million in sales of its first FDA-approved product, sipuleucel-T (Provenge) for prostate cancer. That’s less than the $4.4 million average estimate that analysts had been forecasting, according to Christopher Raymond, an analyst with Robert W. Baird. It’s also a far cry from where estimates had been a couple of months ago, in the $10 million to $12 million range, according to David Miller, the president of Biotech Stock Research in Seattle.

Dendreon said it generated $340,000 in sales of the prostate cancer drug in May, its first month on the U.S. market. Sales ramped up to $2.45 million in June, and then doubled to about $5.2 million in July—although those preliminary figures aren’t included in the second quarter financial report that was filed with the Securities and Exchange Commission.

“We have established a strong foundation for the launch of Provenge, based on the month-over-month revenue growth and positive coverage guidelines published by local Medicare carriers and private payers,” said Hans Bishop, Dendreon’s chief operating officer, in a statement. “Demand for Provenge is strong, as we have already received prescriptions for more than 500 patients during the first three months.”

Shares of always-volatile Dendreon fell 33 cents in after-hours trading to $33.50 at 4:31 pm Eastern Time.

Dendreon is hosting a conference call at 4:30 pm Eastern/1:30 pm Pacific to update investors on the market rollout of its new treatment. I’ll update this space when I have more information.

http://www.investorvillage.com/smbd.asp?mb=971&mn=365376&pt=…

matthewherper
$DNDN: 14 of the 15 Medicare Administrative Contractors have made some communication that they will cover Provenge. 1 minute ago via web

[Berliner_Landstreicher]

Na dit waren ja gestern beschissene Zahlen. Voll räudig! Den Umsatz kann man ja nachvollziehen kurz nach der Zulassung, aber was Brutto vom Gewinn übrig bleibt (gross profit) hab ich so lausig selten gesehen. Provenge wird über kurz oder lang durch bessere Medikamente ersetzt werden. Zu teuer, zu schwach in der Wirksamkeit und auch sonst Schmutz.

93T$ pro Woche für ein paar Tage überleben. Dafür könnte man sich eine Mausoleum bauen. Das hält für die Ewigkeit.

Berliner sind die Größten!

[crivit]

Antwort auf Beitrag Nr.: 39.924.367 von Berliner_Landstreicher am 04.08.10 09:03:09

http://blogs.wsj.com/health/2010/08/03/for-dendreon-its-500-…

Du wirst Dich noch wundern wo der Kurs Ende dieses Jahres stehen wird.
Ab nun geht es aufwärts.
ICh bleibe LONG.
IMO

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.924.367 von Berliner_Landstreicher am 04.08.10 09:03:09

Na, Du hast ja eine super Ahnung von Dendreon

Needham & Company Reiterates a 'Buy' on Dendreon (DNDN); Potential Product Revenue and Manufacturing Build-Out

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Dendreon (DNDN) Higher After Positive Provenge Reimbursement News
Dendreon (DNDN) Announce Publication of PROVENGE Phase 3 in NEJoM
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FBR Capital Reiterates an 'Underperform' Rating on Quanta Services (PWR); 2Q10 First Look - Revenue Below - Guidance Cut
Ticonderoga Securities Maintains a 'Neutral' on NYSE Euronext (NYX); NYX 2Q Wrap-Up
Ticonderoga Securities Maintains a 'Neutral' on GFI Group (GFIG); OTC Opportunity; Plentiful Capital on Hand
Ticonderoga Securities Maintains a 'Neutral' on Molex (MOLX); Delivers Another Quarter of Upside
FBR Capital Maintains an 'Outperform' on Electronic Arts (ERTS); Strong 1Q; Outlook Unaltered
More News related to Analyst Comments
August 4, 2010 8:11 AM EDT

Needham & Company reiterates a 'Buy' rating on Dendreon Corp (Nasdaq: DNDN), PT $62.

Needham analyst says, "While revenue fell short of expectations in this first quarter of market launch, we are encouraged by the early 3Q10 sales, 500 PROVENGE prescriptions to date, and on-time manufacturing build-out schedule. Our revenue projections for 2010-2013 are unchanged at $71MM, $362MM, $849MM, and $1.2B. While revenue represents a quantifiable figure for assessment during the PROVENGE launch, we believe that 2010 is really about “getting it right,” in terms of PROVENGE manufacturing, delivery, ease of use, and reimbursement. Although the underlying purposes and the potential outcomes of the NCA are unclear to us, we do not expect potential NCD will restrict the on-label usage of PROVENGE, which has demonstrated solid survival benefits in well designed, randomized clinical trials."

To see all the upgrades/downgrades on shares of DNDN, visit our Analyst Ratings page.

Dendreon Corporation (Dendreon) is a biotechnology company focused on the discovery, development and commercialization of therapeutics that may improve cancer treatment options for patients.

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[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.927.568 von Magnetfeldfredy am 04.08.10 15:44:34

Die Aktie steigt um 4 US Dollar, die Aussichten sind so gut wie vor der Zulassung, wow!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.927.743 von Magnetfeldfredy am 04.08.10 15:59:25

Auch nicht schlecht:

Baird Reiterates an 'Outperform' Rating on Dendreon (DNDN); Positive Q210; Provenge Solidly on Track

More News related to DNDN
Morning Movers 8/4: SKYW, WWWW, EMMS, PCLN, FTLK, BKS, SGK Higher; DSCM, SMCI, DTPI, PBI, LEAP, TIE Lower
Baird Reiterates an 'Outperform' Rating on Dendreon (DNDN); Positive Q210; Provenge Solidly on Track
Needham & Company Reiterates a 'Buy' on Dendreon (DNDN); Potential Product Revenue and Manufacturing Build-Out
Dendreon Reports Second Quarter 2010 Financial Results
Dendreon (DNDN) September volatility elevated at 70, November at 75
More News related to DNDN
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Baird Reiterates an 'Outperform' Rating on Dendreon (DNDN); Positive Q210; Provenge Solidly on Track
Capstone Investments Downgrades Immersion Corp (IMMR) to Hold; Limited Near-Term Catalysts + Valuation
Citi Maintains a 'Hold' on Whole Foods Market (WFMI); In Line Quarter; Raising Estimates
Citi Maintains a 'Hold' on RTI International Metals (RTI); Airbus Adds Visibility into 2011
Susquehanna Boosts Price Target On Priceline.com (PCLN) to $310
More News related to Analyst Comments
August 4, 2010 10:38 AM EDT


Baird reiterates an 'Outperform' rating on Dendreon (Nasdaq: DNDN), price target $64.

Baird analyst says, "We expect DNDN shares to be up this morning on Q210’s detailed, positive Provenge update. We believe that most investors will look past Q210’s Provenge shortfall, as July sales were $5.2M despite a 10-day facility shutdown. We think this result combined with measurable reimbursement progress and reiterated first-year guidance of 2,000 treated patients will be sufficient to keep DNDN shares working here. Remain buyers."

To see all the upgrades/downgrades on shares of DNDN, visit our Analyst Ratings page.



Dendreon Corporation (Dendreon) is a biotechnology company focused on the discovery, development and commercialization of therapeutics that may improve cancer treatment options for patients.

[Elrond]

hammerhart ....

[crivit]

Antwort auf Beitrag Nr.: 39.925.907 von crivit am 04.08.10 12:14:37

Ende des Jahres 65 USD.
Nur meine Meinung.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.928.500 von crivit am 04.08.10 17:11:10

Bin einverstanden!

[GuHu1]

http://www.streetinsider.com/Analyst+Comments/Needham+&+Comp…


http://www.investorvillage.com/smbd.asp?mb=971&pt=msg&mn=365…



http://biomedreports.com/articles/most-popular/49517-rxnews-…


http://www.xconomy.com/seattle/2010/08/03/dendreon-conferen…


http://blogs.wsj.com/health/2010/08/03/for-dendreon-its-500-…

[GuHu1]

Antwort auf Beitrag Nr.: 39.929.348 von GuHu1 am 04.08.10 18:54:56

http://www.fool.com/investing/high-growth/2010/08/04/dendreo…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.929.770 von GuHu1 am 04.08.10 20:02:38

Hi GuHu1,

nicht schlecht der Tag, was?

Was glaubst Du, bringt die nahe Zukunft?

Gruß

Fredy

[GuHu1]

Antwort auf Beitrag Nr.: 39.930.055 von Magnetfeldfredy am 04.08.10 20:41:01

erstmal glückwunsch zu deinem einstiegskurs, haste dich nach unten erst einmal abgesichert.

die nachfrage ist groß, die erweiterung von nj auf 100% läuft (derzeit 25%), bau der weitern 2 produktionsstätten läuft nach plan.
mal am rande: dndn baut derzeit eine eigene infrastruktur auf, hat das überhaupt einer registriert?

row partner ist noch offen, bzw. wird durch dndn eigenständig abgedeckt. wer weiss

klärung der "National Coverage Analysis (NCA)" initiert durch "Medicare and Medicaid Services (CMS)" nimmt hoffentlich weitere unsicherheit aus dem wert. bin da nach den statements von ASCO und ACCC recht zuversichtlich, aber wer weiss.
ich persönlich halte die diskussion bzgl. der kosten eh für einäugig.

trials zum einsatz von provenge in früheren phasen der krankheit laufen, welchen kursverlauf erwartest du wenn die fda ( möglicherweise) eine label erweiterung approved ?

Metastatic, castrate resistant (hormone refractory) prostate cancer trials:
•P07-2 (ProACT–treatment of PROstate cancer with Active Cellular ImmunoTherapy), is an ongoing Phase 2 trial currently recruiting participants
Hormone sensitive prostate cancer trials:
•PROTECT (PROVENGE® (sipuleucel-T) Treatment and Early Cancer Treatment), also known as P-11, is an ongoing Phase 3 trial, but not recruiting participants
•P07-1 (NeoACT–NEOadjuvant Active Cellular ImmunoTherapy) is an ongoing Phase 2 trial currently recruiting participants

http://www.dendreon.com/research-development/sipuleucel-t/

frag mich nicht nach kurszielen, da habe ich mich von je her zurückgehalten.
ich bleibe aber bei meinem früheren statement: ich bin mit einem buyout von $50 nicht zufrieden!

Ps: bin auch gebürtiger berliner und finde den spruch "berliner sind die größten" von Berliner_Landstreicher echt peinlich.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.930.605 von GuHu1 am 04.08.10 22:07:33

Danke GuHu1,

souverän bist Du!

[GuHu1]

http://www.prnewswire.com/news-releases/patheon-signs-techno…

Patheon signs technology transfer agreement with Dendreon

RESEARCH TRIANGLE PARK, NC, Aug. 5 /PRNewswire-FirstCall/ - Patheon (TSX: PTI), a global provider of drug development and manufacturing services to the international pharmaceutical industry, announced today that it has signed a technology transfer agreement with Dendreon Corporation for commercial supply of proprietary density gradient solutions required during the PROVENGE(R) (sipuleucel-T) manufacturing process. PROVENGE was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2010 for the treatment of asymptomatic or minimally symptomatic castrate resistant (hormone refractory) prostate cancer.

"We are very excited that Dendreon has chosen Patheon to help them bring to market this promising new therapy. Our agreement is further evidence that we are being recognized in the industry as the contract development and manufacturer of choice. We have dedicated ourselves to understanding our customer's needs and developing both the capability and capacity to deliver on those needs. We're happy that Dendreon has trusted us to be part of the commercialization of this product," said Wes Wheeler, Patheon's Chief Executive Officer and President.

PROVENGE is the first autologous cellular immunotherapy to be approved by the FDA and is based on a unique technology platform.

ABOUT PATHEON

Patheon is a leading global provider of contract development and manufacturing services to the pharmaceutical industry. Patheon prides itself in providing the highest quality products and services to approximately 300 of the world's leading pharmaceutical and biotechnology companies. Patheon's services range from preclinical development through commercial manufacturing of a full array of dosage forms including parenteral, solid, semi-solid and liquid forms. Patheon uses many innovative technologies including single-use disposables, liquid-filled hard capsules and a variety of modified release technologies. Patheon's comprehensive range of fully integrated Pharmaceutical Development Services includes pre-formulation, formulation, analytical development, clinical manufacturing, scale-up and commercialization. Patheon can take customers direct to clinic with global clinical packaging and distribution services and Patheon's Quick to Clinic(TM) programs can accelerate early phase development projects to clinical trials while minimizing the consumption of valuable API. Patheon's integrated development and manufacturing network of 11 facilities and eight development centers, across North America and Europe, ensures that customer products can be launched timely and confidently anywhere in the world

[GuHu1]

nur mal so zum spielen.

http://www.dendreon.com/careers/

#Requisition Number: 660
Job Title: Director of Operations, Technology Transfer
Area of Interest: Operations

City: Seattle

State: Washington

Field Based?: No
Job Description: Dendreon is seeking a Director of Operations for Technology Transfer to lead the replication of the established commercial manufacturing process to future facilities, domestically and aboard, as appropriate with Dendreon’s growth strategies. This role would be take the lead in establishing new manufacturing facilities ahead of or in tandem with the facility General Manager (GM) and would ensure that all components of the start-up have been implemented to the standards Dendreon has established with all other facilities. A successful candidate will bring a combination of strong leadership and communication skills with a solid understanding of the manufacturing process and culture. This is a great opportunity to contribute to quality manufacturing in a first-in-class cancer treatment.

• Evangelize the successful implementation of process from one commercial manufacturing facility to another.
• Lead the creation and maintenance of a standardized manufacturing facility start-up playbook and readiness checklist, facilitating input from multiple disciplines including Facilities, Human Resources, Training, Information Technology, Manufacturing, Supply Chain, Quality and Operations.
• Update the playbook and readiness checklist as necessary to support future expansion outside the United States or in clinical and contract manufacturing as appropriate to Dendreon’s goals for growth.
• Collaborate with the Process Excellence team in findings and strategies that would benefit existing facilities.
• Provide single point leadership for the cross functional team in the start-up of a facility including timeline, issue and risk management for facility build-out, hiring and training, communications, electronic system connectivity, initial forecasting, shift strategy and readiness.

Requirements: • Bachelor’s degree in a science or equivalent.
• 10 years of related experience in biotech or similar, manufacturing and/or operations.
• Experience with cGMP/FDA regulations.
• Experience with inspections/audits by the FDA and other regulatory agencies.
• Familiarity with technology transfer, CMC sections for BLA, and building a quality infrastructure to support commercial products.
• Proficient in MS Office applications
• Strong written and verbal communication skills, and ability to present technical information to multi-disciplinary groups.

Working Conditions & Physical Requirements: • Extended travel will be required.
• Handling of biologic materials.
• May be required to work alternate shifts or off hours as issues arise.

The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

[crivit]

GuHu1 und Magnetfeldfredy, ich wünsche Euch ein schönes WE.
(Auf steigende Kurse)

[GuHu1]

Antwort auf Beitrag Nr.: 39.944.739 von crivit am 06.08.10 20:58:46

danke crivit

das folgende könnte für den negtiven knick in deinem chart verantwortlich sein.
die aufregung hat sich schnell wieder gelegt und es wurde da eingestuft wo es hingehört, ändern und ablage rund.

http://www.fda.gov/BiologicsBloodVaccines/GuidanceCompliance…

PROVENGE (sipuleucel-T) - Untitled Letter
DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and
Research
1401 Rockville Pike
Rockville, MD 20852-1448

August 3, 2010

Helen Kim
Director of Regulatory Affairs
Dendreon Corporation
3005 First Avenue
Seattle, WA 98121

Re: PROVENGE® (sipuleucel-T)
BLA STN# 125197

Dear Ms. Kim:

The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has reviewed an In Service Kit (P-A-04.10-007.00) (kit) and PROVENGE Detail Aid (P-A-04.10.009.00) (detail aid) for PROVENGE® (sipuleucel-T). Dendreon Corporation (Dendreon) submitted the kit and detail aid under cover of Form FDA 2253 on May 4 and May 27, 2010, respectively.

These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of PROVENGE. Therefore, this material misbrands PROVENGE under sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(a) and §321(n), and FDA implementing regulations, Cf. 21 CFR 202.1(e)(5)(iii) and (e)(6)(i).

Background

According to the FDA-approved prescribing information (PI), PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

The Warnings and Precautions section of the PI includes, but is not limited to, the following risks for PROVENGE:

PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination.

According to the Clinical Studies section of the PI, the effectiveness of PROVENGE was studied in 512 patients, “randomized in a 2:1 ratio to receive PROVENGE (n=341) or control (n=171).” This study “was a randomized, double-blind, placebo-controlled, multicenter trial in patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.” As shown in Table 2, the observed median survival time for patients randomized to the PROVENGE arm was 25.8 months and for patients randomized to placebo was 21.7 months. The Hazard Ratio was 0.775 (95% Confidence Interval: 0.614, 0.979). The study achieved a p-value of 0.032 based on a log-rank test (not pre-specified).

Omission and Minimization of Risk Information

Promotional materials are misleading if they fail to reveal facts that are material in light of representations made with respect to consequences that may result from the use of the product as recommended or suggested by the materials.

Specifically, the kit presents a misleading product timeline on the slide entitled, “Is PROVENGE therapy approved for infusion?” The timeline includes “Test Results Complete” before the product arrives at the office, which is contrary to the Warnings and Precautions section of the PI which states that the final (7-day incubation) sterility test results are not available at the time of infusion. Furthermore, the kit omits the Warning and Precaution that the final sterility test results are not available at the time of infusion.

Overstatement of Efficacy

Promotional materials are misleading if they contain a representation or suggestion, not approved or permitted for use in the labeling, that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience.

Page seven of the professional detail aid includes a chart entitled, “Kaplan-Meier Survival Rate Estimates.” This chart presents the percentage of patients alive at 12, 24, 36 and 48 months. This information is misleading because it does not provide sufficient contextual information for the presented survival rate estimates to convey the limitations of the study. For example, the chart does not include a measure of variability, such as the 95% confidence intervals, when presenting the survival rate estimates.

Conclusion and Requested Actions

For the reasons discussed above, your promotional material misbrands PROVENGE under sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §352(a) and §321(n), and FDA implementing regulations, Cf. 21 CFR 202.1(e)(5)(iii) and (e)(6)(i).

We request that Dendreon immediately cease the dissemination of these violative promotional materials for PROVENGE, as well as promotional materials with the same or similar representations. Please submit a written response within ten (10) business days of the date of this letter, stating whether you intend to comply with this request, listing all violative promotional materials for PROVENGE and explaining your plan for discontinuing use of such materials. Please direct your response to Lisa Stockbridge, PhD, Acting Branch Chief at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Division of Case Management, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. In all future correspondence regarding this matter, please refer to the BLA/STN number. We remind you that only written communications are considered official responses.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for PROVENGE comply with each applicable requirement of the Act and FDA implementing regulations.

If you choose to revise your promotional materials, APLB is willing to assist you in assuring that your revised materials comply with applicable provisions of the Act by reviewing your revisions before you use them in promotion.

Sincerely,

Robert A. Sausville
Director, Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

[crivit]

Technically, Dendreon Is a Buy
http://www.fool.com/investing/high-growth/2010/08/17/technic…

[GuHu1]

Welcome to the ASCO in Action webpage. From health care reform to physician reimbursement to access to quality care, this page spotlights timely information on research policy, clinical affairs, government relations, and quality of care issues that affect your practice, cancer care, and cancer research.

If you are an ASCO member, please feel free to e-mail [e-mail] with any questions or concerns you have on these and other legislative and policy issues.

August 23, 2010

ASCO Urges CMS to Withdraw National Coverage Analysis for FDA-Approved Cancer Drug
Recently, ASCO submitted comprehensive comments to the Centers for Medicare & Medicaid Services (CMS) expressing concern regarding its decision to open a national coverage analysis (NCA) for an FDA-approved cancer treatment.

In this instance, the NCA involves sipuleucel-T (Provenge). Federal law envisions that the Medicare program will provide coverage for FDA-approved cancer indications. However, ASCO’s comments raise broader concerns regarding the lack of clarity for the basis of the NCA and the implications this example may have for other FDA-approved cancer treatments. ASCO urged CMS to withdraw the current NCA and look for other mechanisms to gather information, such as a potential meeting convening scientific experts to address specific questions or a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). ASCO requested that the agency provide clear guidance regarding Medicare’s current policies governing coverage of this therapy and that CMS address the issue of how any potential future changes in coverage policies could impact individuals already receiving a therapy that becomes subject to review under a NCA.

http://www.asco.org/ascoaction

[GuHu1]

CEO: other states "aggressive" about recruiting Dendreon


Dendreon is one of the bright lights of Washington state's biotechnology industry. The Seattle-based company received FDA approval for its prostate cancer drug Provenge in April and has been on a hiring tear lately.

The company, which had a staff of about 150 two years ago, today employs close to 1,000 people, Dendreon CEO Mitchell Gold told a packed Business Journal Live audience at the Harbor Club Bellevue Tuesday morning.

But Gold also offered up an extensive critique of Washington state's approach to biotech and said other states are being "aggressive" about recruiting Dendreon.

Gold raised concerns about Initiative 1098, a November ballot measure that would raise income tax on the state’s wealthiest residents.

"Raising the state income tax may make recruiting here more difficult," Gold said.

He pointed to the state of Georgia, where Dendreon is building a a $70 million manufacturing plant in the Atlanta area.

"The state of Georgia gave us $20 million in tax-free funding to support training," Gold said. "A lot of other states are being aggressive about recruiting Dendreon to their region."

Dendreon also has a New Jersey facility and is building another in Orange County, Calif.

Describing Dendreon, which has a market capitalization of $5.2 billion, as an "anchor tenant" for Washington state's biotech industry, Gold said: "Everyone wants that anchor tenant. I’m hopeful that the state will continue to be very entrepreneurial in creating a biotech industry. It’s a hot commodity."

Gold said Washington needs a "for-profit venture capital arm for the state so you can spin technology out of the University of Washington and the Hutch (Fred Hutchinson Cancer Research Center) and create growing profitable entitites." He again brought up Georgia, noting that it has a "for-profit VC arm."

Of Washinton state, he added: "This is one of the premier states for cancer research in the world," adding, "We took the Life Sciences Discovery Fund from the tobacco settlement and said it couldn’t invest in for-profit entities. It’s sort of ridiculous."

"We actually have all the necessary infrastructure to put Seattle on a par with Boston or San Francisco," Gold continued. "What we lack in the state is a wide range of venture capital that these companies can access."

Gold also talked about how cancer has claimed several close members of his family, and said the U.S. needs to devote more resources to cancer research generally.

"It's an epidemic," he said. "This country has become completely complacent about its ability to deal with it."

Read more: CEO: other states "aggressive" about recruiting Dendreon - Puget Sound Business Journal (Seattle)

http://www.bizjournals.com/seattle/blog/2010/08/dendreon_ceo…

[GuHu1]

http://caretolive.com/

[NoSelters]

Antwort auf Beitrag Nr.: 40.046.459 von GuHu1 am 26.08.10 00:08:51

Hallo GuHu,

auf die Antwort bin ich gespannt!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.049.427 von NoSelters am 26.08.10 14:03:41

Ich auch!

Auch ganz nett:
3 Stocks That Will Go Up in a Double-Dip Recession
4 comments | by: James Altucher August 26, 2010 | about: CSH / DNDN / LPS Font Size: PrintEmail Recommend 0 Share this page
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an article to The first article I read this morning, (at 3:56am, my early morning, pre-coffee, article read before catching a 4:40am train), started off with: "Stocks are likely to face another choppy, downtrodden week, but that's no big surprise". Man, someone is depressed. But it's not just that article writer, everyone really is depressed. Things are ugly out there. Even though we have GDP growth, even though retail sales are up significantly year over year,even though GM, that beacon of American industry, is coming public after two back-to-back profitable quarters, everyone assumes we are heading towards a double-dip.

We also have visceral memories of what happened the last time the country was in a recession (October, 2008). The entire world fell apart and the S&P skidded almost 1000 points. The world really felt like it was ending. I lived on the corner of Wall and Broad at that time. You couldn't find any light in people's eyes. It was like land of the zombies as traders marched into the New York Stock Exchange across the street. Nobody wants that again. Nobody wants to be a zombie.
But the reality is, shorting the market at the worst, most depressing moments would've cost you money. Lots of it. The sad, depressing moments are when you want to stop listening to economists and you want to start looking for stocks. Heck, I should stop reading these early morning, "lets get the week started" articles. Particularly before my first coffee of the day.
Let's be smart about it, though. If you're worried about a double dip, pick stocks that could go up long-term if the economy goes down from here, but also have a decent chance if the economy goes up:
Lender Processor Services (LPS). A spnoff of Fidelity National, LPS provides technology and services to the mortgage and real estate industries. Its business has been booming lately. How come? I thought mortgages were heading towards their lows? Well, when people stop paying a mortgage, a foreclosure is a long and complicated process. LPS is there every step of the way helping banks and lenders foreclose on properties. Not the funnest job in society (I highly recommend the 1980s movie "Repo Man") but profitable. The company trades for just 7 times forward earnings. This is a classic spinoff play that drops when the holders of the parent don't want the child (so there is irrational selling).
Cash America (CSH) I first recommended this on CNBC in February 2009 when it was trading at $14. Now its at $30 and still cheap because of the massive growth they've experienced during this recession, as predicted.
- about 70% of their revenues are pawnshop, 30% payday lending.

Pawnshops are great because you loan the money AND keep the

collateral, which is usually valued at about a 20-50% loan to value.

And the interest rates are extremely high.

- trades at about 5 times cash flows.

- very cheap right now because of worries about regulatory issues.

Ohio just stopped payday lending for instance and CSH had to close its

stores there. However, this is particular to Ohio and has not been a

major trend. If payday lending stopped then millions of voters would

be without banking.

- ironically, inflation is helping CSH because the prices of the gold

bracelets, necklaces, etc in their pawn shops are going up.

Dendreon (DNDN) - of course I have to pick Dendreon. Prostate cancer has nothing to do with the economy and is one of the biggest killers of men. Provenge is the first FDA-approved drug that will significantly improve survivability of the cancer. In trials for men over the age of 65 in late stages of the disease the survival rate was 23 months versus 17 months for the control group. When this company is making $800mm in earnings by selling the drug its not going to have a $5bb market cap but will end up being acquired for $10bb+. The stock is still at the same levels it was at pre getting approval for their drug. I expect this will be a $70 stock no matter which direction the economy goes.Ignore the stocks that everyone is focused on. Even though AAPL and GOOG are the greatest companies in the world, they will go up and down with the market. And while Goldman Sachs (GS) was the one major bank to basically survive unscathed during the last recession, I wouldn't count on it for any potential next double dip given the amount of hate and fear its engendered among the populace.
While I don't think we are in a double-dip, it's always good to hope for the best and prepare for the worst. These three stocks will do well in a double-dip but also do well in a rising economy for the reasons described. Protect your portfolio.

[GuHu1]

Antwort auf Beitrag Nr.: 40.051.274 von Magnetfeldfredy am 26.08.10 18:13:17

stimmt ist auch ganz nett.

[NoSelters]

GAP ??

Sehe ich das richtig,daß wir bei 33,83 noch ein offenes Gap haben?

@ Hakur---hättest Du nicht mal wieder Lust eine unverbindliche Chartprognose abzugeben?

Good Luck to all Longs....

[GuHu1]

http://www.georgiaquickstart.org/features.php?featureID=f813…

[GuHu1]

http://www.thestreet.com/story/10849106/1/dendreon-gets-date…

[hakur]

Antwort auf Beitrag Nr.: 40.057.067 von NoSelters am 27.08.10 15:44:53

Hi No Selters,
muß leider auf die Seite im IV verweisen!
habe nicht allzu viel Zeit und weus der Teufel warum bekomme auch keinen Chart hier reingeklebt
Funktioniert nicht.
Viel Glück allen Looongies und entspanntes zurück lehnen die nächsten Jahre

Hier die IV adresse
http://www.investorvillage.com/smbd.asp?mb=971&mn=368866&pt=…

[NoSelters]

Antwort auf Beitrag Nr.: 40.083.642 von hakur am 01.09.10 17:46:09

Danke...hab Deinen Beitrag bereits gesehen.
(Urlaub sei jedem mal gegönnt...)

So looong...

[GuHu1]

Antwort auf Beitrag Nr.: 40.083.681 von NoSelters am 01.09.10 17:51:45

http://blogs.wsj.com/health/2010/09/01/dendreon-shares-up-on…

By Katherine Hobson
Shares in Dendreon rose more than 6% after Medicare authorities scheduled a Nov. 17 meeting to consider coverage of the company’s Provenge prostate-cancer treatment — and investors concluded the question of whether or not to pay for the therapy was not an issue.

As TheStreet.com reported last night, CMS said the meeting will “consider the currently available evidence regarding the impact of labeled and unlabeled use of autologous cellular immunotherapy treatment on health outcomes of patients with metastatic prostate cancer.” Here’s the CMS announcement.

Analysts are interpreting that “labeled and unlabeled” bit to mean that CMS is going to be looking at which patients should be treated with Provenge, not at whether it should be covered at all. TheStreet.com quotes a research note from a Deutsche Bank analyst as saying she expects Medicare coverage to track the patient criteria for which the FDA approved its use in late April — that is, those whose cancer has spread beyond the prostate, who have no pain requiring narcotic treatment and whose disease has not responded to hormone-blocking treatments.

Shares in the company rose 6.4% to $38.12 in early afternoon trading after earlier hitting $38.49.

Biotech Stock Research, an independent research group, said via Twitter that it, too, still expects the so-called national coverage determination to “cover Provenge’s label,” or the indications for which it was approved by the FDA. CMS announced this summer its plans to initiate the coverage analysis.

In the meantime, regional Medicare carriers are free to decide whether to cover the drug — on its 2nd-quarter earnings call, Dendreon said almost all of the carriers intended to do so. It also said total revenue for the treatment through July was about $8 million and that 500 prescriptions had been written. The Health Blog calculated that between about 86 and 258 patients had at least started treatment.

[crivit]

UP SHE GOES!

[crivit]

Antwort auf Beitrag Nr.: 40.090.746 von crivit am 02.09.10 18:05:12

ZIEEHHH, ich will die 50$$$$$$$$ sehen!

[crivit]

Antwort auf Beitrag Nr.: 40.091.507 von crivit am 02.09.10 20:03:58

Bis Ende September!

[GuHu1]

Antwort auf Beitrag Nr.: 40.091.541 von crivit am 02.09.10 20:08:21

die unsicherheit weicht.

http://www.fool.com/investing/high-growth/2010/09/01/dendreo…

[edelupolino]

Antwort auf Beitrag Nr.: 40.091.943 von GuHu1 am 02.09.10 21:10:48

Hi GuHu1,
gerade in "The Street" gefunden (natürlich über Rivalen von Dndn); als Laie kann ich nicht beurteilen, wie gut diese Mittel sind:
http://www.thestreet.com/story/10857472/1/jj-prostate-cancer…
Möge das Glück auf unserer Seite bleiben
Ciao Ede

[GuHu1]

Antwort auf Beitrag Nr.: 40.151.820 von edelupolino am 14.09.10 23:33:59

hi ede, als laie fällt mir dieser absatz ins auge:

...For now, abiraterone does not pose a competitive threat to Dendreon's Provenge because the patients treated with the newly launched prostate cancer immunotherapy have less advanced disease than those treated in the abiraterone study.
Doctors administer Provenge to patients who also have advanced prostate cancer but before chemotherapy drugs like Taxotere are used. In the J&J trial, abiraterone was used after chemotherapy. ...

by the way...

http://www.prnewswire.com/news-releases/the-karmanos-cancer-…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.158.735 von GuHu1 am 15.09.10 22:49:01

Servus GuHu 1,

sehr gut analysiet! Ich hab heute der Präsentation gelauscht, eindrucksvoll aber sollte keine flächendeckende Erstattung kommen wird ein Fonds gegründet damit die Prostatakrebskranken behandelt werden können, eine Win-Win Situation!

[GuHu1]

Antwort auf Beitrag Nr.: 40.158.783 von Magnetfeldfredy am 15.09.10 23:02:33

abwarten, der termin (cms) dazu wurde ja vorverlegt und das um 6 monate.
an unterstützung hat es in der öffentlichen meinungsäußerung nicht gemangelt (ASCO z.b.)
hab nicht gelauscht, bezieht sich das mit dem fond auf die label oder off label verschreibung?

[GuHu1]

sind wiedermal übernahmegerüchte im umlauf.... roche u.a. wird wieder ins spiel gebracht.... naja gerüchte halt.

theflyonthewall.com: On The Fly: Rumor Buzz
Market speculation today includes Riverbed Technology (RVBD), up about 3%, on renewed takeover speculation by Cisco Systems (CSCO). Cisco competes with Riverbed in the networking and communications devices industry...Harley-Davidson (HOG) moves up over 2% on renewed private equity speculation...Coventry Health Care (CVH) is the subject of renewed takeover speculation by Aetna (AET)...Dendreon Corp. (DNDN) is up nearly 2% on renewed takeover speculation...Rambus (RMBS) is again the subject of renewed takeover speculation and possible interest from Samsung...Clifff Natural Resources (CLF) has also been mentioned as a possible takeover target. :theflyonthewall.com

[edelupolino]

Antwort auf Beitrag Nr.: 40.158.735 von GuHu1 am 15.09.10 22:49:01

Hi GuHu,
danke für den "Karmanos"-artikel!
Ciao

[crivit]

Dendreon inks supply deal with Glaxo on cancer vaccine
http://www.reuters.com/article/idCNSGE68K0HL20100921?rpc=44

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.185.763 von crivit am 21.09.10 16:08:12

Hört sich gut an wenn auch 8 Millionen nicht der Burner sind, oder?

[GuHu1]

Antwort auf Beitrag Nr.: 40.187.439 von Magnetfeldfredy am 21.09.10 19:41:30

hi fredy, glaxo liefert dndn das benötigte antigen zu den genannten konditionen, heißt soviel wie man ist vorbereitet für den ausbau ...... (second source).

[GuHu1]

ich darf doch hakur , aus dem IV:

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.188.015 von GuHu1 am 21.09.10 20:57:36

Danke ich hab das mißverstanden, auf alle Fälle ist das Interesse auch außerhalb der USA da!

[GuHu1]

das kenn ich doch irgend wo her......

http://www.thestreet.com/story/10868619/1/dendreon-assessing…

Dendreon: Assessing A New Threat to Provenge

BOSTON (TheStreet) -- Investors mindful of competitive threats to Dendreon's(DNDN) newly launched prostate cancer therapy Provenge may have less to fear from AstraZeneca's(AZN) experimental pill zibotentan.
The survival benefit reported earlier in a phase II prostate cancer study of zibotentan has narrowed and is no longer statistically significant, according to a new and final analysis of the study published in a medical journal last week.
This makes it more likely that a closely watched phase III study of zibotentan won't produce results strong enough to knock Dendreon's Provenge from its perch as the king of newly approved prostate cancer therapies.

AstraZeneca is expected to announce top-line results from the phase III zibotentan study in the fourth quarter.

Dendreon fans have been somewhat worried about zibotentan because the drug is being studied in the same type of advanced, hormone-refractory prostate cancer patients who are, right now, eligible for treatment with Provenge, making the drugs direct competitors were zibotentan to be approved.

Moreover, zibotentan is a pill taken once a day, making it more convenient and likely less expensive than Provenge -- a personalized vaccine requiring special manufacturing and three infusions over the course of one month.

Zibotentan earned a certain amount of attention in 2007 when an interim analysis of the randomized, controlled phase II study demonstrated a median survival benefit of seven months compared to a placebo. By comparison, Provenge demonstrated a median four-month survival boost in the phase III study that won the drug approval earlier this year.

Sanofi-Aventis(SNY) recently won approval for a new prostate cancer drug and Johnson & Johnson(JNJ) has its own prostate cancer drug in development that recently posted positive phase III results, Yet compared to AztraZeneca, neither company is seen as much of a near-term direct threat to Dendreon because use of their respective drugs at least initially, is directed towards patients with more advanced disease and after Provenge treatment.

Zibotentan's credibility as a Provenge killer took a hit last week after researchers published a final analysis of the phase II study in the British Journal of Urology, showing zibotentan to be not as effective as previously thought.

At the final analysis conducted in December 2008, patients treated with the higher, 15 mg dose of zibotentan had a median overall survival of 23.9 months compared to a median overall survival of 19.9 months in patients treated with a placebo.

That four-month survival benefit for zibotentan was not statistically significant and was lower than the statistically significant, seven-month survival benefit recorded at an interim analysis of the trial conducted in February 2007.

Overall survival was actually a secondary endpoint in the zibotentan study. The drug also failed to achieve the study's primary endpoint of time to disease progression.
In the study article, researchers note the narrowing of the zibotentan survival advantage over time but say one possible explanation is that doctors in the study stopped treating patients with the drug too soon.

"While these data do make us less worried about zibotentan as a competitive threat, they do not remove that worry," wrote Biotech Stock Research's David Miller in a note sent last week to subscriber's of his biotech investment newsletter. Miller is a long-time Dendreon bull.

"We've always said we expected the phase III ENTHUSE M1 Trial would see a narrowed median survival advantage from the 7.2 months. Now we're potentially talking about a narrowing from 4 months. If zibotentan's median survival number is noticeably less than 4 months (say below 3.6 months) even insurers would be hard pressed to make the case zibotentan should come first," Miller added.

AstraZeneca's is conducting three phase III studies of zibotentan in prostate cancer, the first of which goes by the moniker ENTHUSE M1.

Zibotentan works by blocking receptors on prostate cancer cells that help tumors grow and survive. The FDA rejected the approval of a similar drug developed by Abbott Labs(ABT) in 2005.

Provenge is a cancer immunotherapy that trains a patient's own immune system to identify and destroy prostate cancer cells.

--Written by Adam Feuerstein in Boston.

[GuHu1]

http://www.cancernetwork.com/display/article/10165/1673614

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.195.408 von GuHu1 am 22.09.10 22:31:26

Sehr guter Bericht, was denkst Du, wird Provenge "gelabelt" oder nicht?

[GuHu1]

Antwort auf Beitrag Nr.: 40.195.570 von Magnetfeldfredy am 22.09.10 23:12:22

das ist ne gute frage.
cms termin wurde um ca. 6 monate verkürzt... positive unterstützung u.a. von seiten ASCO....
was soll ich sagen, ich weiß es nicht, ich gehe von einer kostenübernahme für die FDA zugelassene indikation aus.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.200.912 von GuHu1 am 23.09.10 19:53:24

Servus GuHu1, ich auch, aber warum müssen wir Dendronen immer gestresst werden?

[GuHu1]

Antwort auf Beitrag Nr.: 40.201.952 von Magnetfeldfredy am 23.09.10 22:21:50

damit es nicht langweilig wird

[GuHu1]

von saulk (IV)

Today's Federal Register
has a notice of the 11/17 meeting. The summary in the notice reads as follows:

SUMMARY: This notice announces that a public meeting of the Medicare
Evidence Development & Coverage Advisory Committee (MEDCAC)
(``Committee'') will be held on Wednesday, November 17, 2010. The
Committee generally provides advice and recommendations concerning the
adequacy of scientific evidence needed to determine whether certain
medical items and services can be covered under the Medicare statute.
This meeting will focus on the currently available evidence regarding
the clinical benefits and harms of on-label and off-label use of
Autologous Cellular Immunotherapy Treatment of Metastatic Prostate
Cancer. This meeting is open to the public in accordance with the
Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

http://edocket.access.gpo.gov/2010/2010-23582.htm

[GuHu1]

anbei die fragen bzgl. cms meeting zur kostenübernahme
http://www.cms.gov/mcd/viewmcac.asp?where=index&mid=56#quest…

der derzeit härteste konkurrent zu provenge ist nicht nur gestrauchelt, er ist gestürzt.
ich sagte doch, das kenn ich irgend wo her.

http://www.thestreet.com/_yahoo/story/10871543/1/astrazeneca…

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=371304&pt=…

Full report from DB
***Provenge MEDCAC Panel Questions Posted - In-line with Expectations
- Positive Outcome Expected

Today, CMS posted the questions for the upcoming MEDCAC panel on
November 17th to assess whether Provenge should be used in men who
are over 65 years old. The questions appear in-line with
expectations and we expect a positive outcome from the panel.

Key reasons why we expect a positive outcome:
1) The questions are in-line with our expectations
2) The panel is only permitted to use publically available data
3) The drug has shown an overall survival benefit and has no side
effects
4) We expect panel to vote positively to all questions
Please join us for our conference call on Thursday:
!DB-Bio ***Conference Call Invite: Thursday Sept. 30th, 10am –
Dendreon 101 & Where Provenge will fit into the competitive
landscape***


The MEDCAC panel questions can be found at:
http://www.cms.gov/mcd/viewmcac.asp?where=index&mid=56

1) How confident are you that there is adequate evidence to
determine whether or not the use of autologous cellular
immunotherapy treatment of asymptomatic or minimally symptomatic
metastatic castrate resistant prostate cancer significantly improves:

a) Overall survival?
b) Control of disease-related symptoms?
c) Avoidance or minimization of the burdens associated with
anticancer therapy while maintaining overall survival and control of
disease-related symptoms?

2) How confident are you that there is adequate evidence to conclude
that autologous cellular immunotherapy treatment significantly
improves overall survival in patients with asymptomatic or minimally
symptomatic metastatic castrate resistant prostate cancer?

3) How confident are you that there is adequate evidence to conclude
that autologous cellular immunotherapy treatment significantly
improves control of disease-related symptoms in patients with
asymptomatic or minimally symptomatic metastatic castrate resistant
prostate cancer?

4) How confident are you that there is adequate evidence to conclude
that autologous cellular immunotherapy treatment significantly
improves the avoidance of the treatment burdens (e.g., access,
delivery, or side-effects) associated with anticancer therapy in
patients with asymptomatic or minimally symptomatic metastatic
castrate resistant prostate cancer?

5) How confident are you that these conclusions are generalizable to
unlabeled use in:

a) Patients whose prostate cancer has not metastasized?
b) Patients who have metastatic, castrate resistant disease and
symptoms more severe than minimally symptomatic?
c) Patients who have metastatic prostate cancer but who have not
failed hormonal therapy?

6) How confident are you that these conclusions are generalizable to:

a) Community based settings?
b) Patients belonging to demographic groups that may have been under-
represented in the enrolled clinical trial populations?

Discussion Questions

7) Do you believe that there is adequate evidence to identify
patients who are more likely or less likely to respond favorably to
autologous cellular immunotherapy treatment based on pretreatment
evaluation of any of the following factors?

a)Site(s) or number of metastasis(es) as detected by imaging studies
b) Gleason score
c) Alkaline phosphatase (U/L)
d) Hemoglobin (g/dL)
e) Serum LDH (U/L)
f) Serum PSA (ng/mL)
g) Pain associated with metastatic, castrate-resistant prostate
cancer
h) Other

8) What significant evidence gaps exist regarding the health
outcomes attributable to autologous cellular immunotherapy
treatment?
a) For the FDA-labeled indication?
b) For off-label uses?

9) What clinical study designs would adequately address any evidence
gaps?

For more information, please click on the attached document.

Regards,
Deutsche Bank Equity Research

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.218.934 von GuHu1 am 27.09.10 20:04:27

Servus GuHu1,

ein Frechheit diese Fragen, warum hat die FDA zugelassen weil Provenge effektiv und sehr gut verträglich ist!
Da kann die Chemo Lobby wieder Zerstörer spielen und das Panel schmieren, ich bin vor dem Panel raus wenn`s schlecht läuft verliert Dendreon 10 Dollar pro Aktie!

[GuHu1]

deine reaktion ist verständlich.
hab mal ein paar positive reaktionen/überlegungen reingestellt, es gibt sicher auch negative.
durch das wegbrechen von AstraZeneca`s "zibotentan" ist weit und breit keine alternative therapie in sicht....

News Breaks

September 28, 2010
08:51 EDT
DNDN
theflyonthewall.com:
Dendreon shouldn't be strongly impacted by CMS meeting, says Roth Capital

Roth Capital believes that too much is being made about a November meeting at which CMS will discuss Dendreon's Provenge. The firm thinks CMS is only looking to define the patient population for Provenge and prevent off-label use. It maintains a Buy rating on the stock. :theflyonthewall.com

08:26 EDT
DNDN
theflyonthewall.com:
Dendreon weakness a buying opportunity, says RW Baird

RW Baird expects the MEDCAC review for Dendreon's Provenge to go smoothly and is a buyer of the stock on yesterday's weakness. The firm reiterates an Outperform rating on shares with a $64 price target. :theflyonthewall.com
_________________


CMS Questions

Hey folks. Gotta admit that those questions piss me off also but after giving them further, reasoned and level-headed consideration, something I’m not known for, I guess they aren’t that bad after all.
http://www.cms.gov/mcd/viewmcac.asp?from2=viewmcac.asp&where…
So here’s how I think they’ll look at things…
1. The main thing to remember is that ASCO has come out in support of the survival data on Provenge. So any questions on survival will be answered positive by the panel members who are oncologists. That should take care of questions 1a and 2.
2. Questions 1c and 4 are about side effects and availability of Provenge. The answers to those questions will be positive.
3. The main issue is in questions 1b and 3 which are about the lack of a demonstration of improvement in Time-To-Progression. This is where Dendreon will need to do a good job of explaining the delay effect in immunotherapy and the difficulty in having accurate assessment of progression using RECIST on PC tumors. Now, from the data point of view, a survival benefit means that the disease must be slowed down or stopped somehow. So, if one believes in the survival benefit of Provenge (and almost everyone does now!), one must conclude that the failure of TTP was a problem with the measurement methodology and not a problem with the treatment. So, the delay effect and the squishy nature of measuring progression in prostate cancer are the reasons for the failure of TTP.
Dendreon should be able to get a great deal of help on this one. For instance this presentation was just given at The Immunotherapeutics and Vaccine Summit in August…

4:45 Immunotherapy for Prostate Cancer: Explaining the Conundrum of Improved Survival without Improvement in Time to Progression
Ravi A. Madan, M.D., Assistant Clinical Investigator, Lab of Tumor Immunology & Biology, The Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH
Recent clinical data in prostate cancer suggest significantly improved overall survival without any improvement in time to progression. I will present data from recent clinical trials suggesting that both the kinetics of an anti-tumor immune response and impact of an anti-tumor immune response on subsequent therapies may explain this. I will also explain how these concepts may impact which patient populations should be enrolled in immunotherapy clinical trials and provide data from randomized studies. There is considerable confusion within the medical oncology community about how to interpret the overall survival data for immunotherapy studies and what can explain improvements in overall survival. The simple concepts I will present offer explanations that may help alleviate some of the consternation caused by the available data from randomized studies looking at overall survival.
4. Question 5a will likely receive a low score because there is yet little data on the early stages of PC.
5. Questions 5b and 5c may receive a good score, esp, 5b for patients with bone pain but not extensive visceral disease yet.
6. Question 6 will likely receive good scores.
Overall, I think the process will result in a slightly extended label beyond the FDA approved label.
That’s my two bits.

http://www.investorvillage.com/smbd.asp?mb=971&mn=371384&pt=…

[GuHu1]

http://caretolive.com/
The Associated Press Gets It Wrong!September 28th, 2010 | Posted by CTL

Share This

The Associated Press (AP) sent a story out over the wire this past Sunday which, sadly, was picked up by many newspapers and media outlets. It erroneously reported information about Provenge and showed a severe editorial bent by only interviewing doctors who have conflicts. Those conflicts should have been stated.

The writer, Marilynn Marchione, first raises eyebrows with the way she uses quotation marks. She quotes a patient who says he “would not spend that money” and then she jumps out of the quotations to give a reason why, “because the benefit doesn’t seem worth it.” Was it his reason or her reason? Later on she quotes him as saying “I feel very lucky”, so obviously he isn’t saying the benefit is not worth it.

She mixes up the price. Sure it is expensive. It took 15 years and billions of dollars to get it approved by the dysfunctional FDA. It should have been approved back in 2007. But the $93K is for a one time treatment, not $93K every year. Here is a great article showing how people like Marilynn Marchione can butcher the facts. Chemo still costs more because of hospital stays and more meds to treat its toxic side effects, not to mention the negative quality of life which Provenge does not have. But nobody is complaining about the expensive chemo. Why not?

http://www.minyanville.com/businessmarkets/articles/dendreon…

We find a lot of other things wrong with this deceiving article. Here’s what a friend of CTL has to say about it:

“First of all, the “adds 4 months survival, on average” statement is incorrect. Four months was the MEDIAN (not average) survival seen in the Phase III trial. That means that half the patients survived less than 4 months, half the patients survived more than 4 months. The median is the midpoint in the survival range, not the average survival. Most commentators and reporters get this wrong. I know of at least one patient who survived about 4 years and there are many who survived years rather than only months.

“Secondly, the $93,000 price is one-time, not an annual cost. There is no hospital stay with Provenge and, perhaps more importantly, there are very few side-effects. Those side effects are mainly cold-like and flu-like symtoms for a day or two and that’s it. A patient undergoes a procedure called leukophersis (essentially blood-drawing) in his doctor’s office and a few days later returns for infusion of the Provenge-treated cells. Perhaps 2-3 hours for the IV to complete. Provenge is the first FDA-approved cancer immunotherapy and a paradigm shift in the way prostate cancer is treated.

“I have followed Provenge closely since September 2003 and I am well acquainted with how it works, because there is a history of prostate cancer in my family.”

CareToLive also disagrees with the writer’s survival information with the fact that 67% of the patients were taken off placebo for ethical reasons and given Frovenge. Frovenge is a frozen variant of Provenge from the patient’s blood. Since they gave blood just like the Provenge patients, it was frozen with some Provenge so it could be given back to them later. The Frovenge patients survived a little longer so Provenge was actually competing against itself in these trials which were for the worst case scenarios.

We hope the AP sends out a correction and interviews people who do not have conflicts so the audience can hear both sides of the story.

Popularity: 1%
Tags: AP, CareToLive, CTL, Dendreon, Johnson & Johnson, M.D. Anderson, Prostate Cancer, provenge, The Associated Press

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.227.532 von GuHu1 am 28.09.10 21:33:22

Hi GuHu1,

Michael Murphy vom Newworldinvestor bleibt auch an der Seitenlinie bis die Shorties Ihr dreckiges Spiel gespielt haben:

Michael Murphy says:
September 29, 2010 at 12:47 pm
I have a question for everyone. I am beginning to think the CMS review of Provenge is another run at us by the shorts.
1. Who asked for the review?
2. In the AP story, the last quote is from M.D. Anderson’s prostate cancer research chief, Dr. Christopher Logothetis. He is a lead investigator for Dendreon’s competitor, Cougar Biotech. Courgar Biotech was a Milliken investment and figured prominently in the last attack.
http://www.deepcapture.com/michael-milken-60000-deaths-and-t…
3. The argument against Provenge is based on supposedly previously unavailable data, and has been laid out by someone who could have been paid to spend a lot of time coming up with the theory that Provenge is not useful for men over 65 and/or that men on Provenge die earlier than placebo patients. (See the comments on http://blogs.forbes.com/matthewherper/2010/08/31/medicare-me…
This is FUD, but it is manipulated-data FUD as in the ARNA meeting.
4. We don’t know if anyone on this committee has been bribed by the shorts.
5. The paid bashers are out in force on the DNDN Yahoo Board, validating each others’ posts.

The pattern is the same as we have seen before. Do we want to fight them? Or would it be wiser to step aside now, let them play their game into the November 17 meeting, see what happens, and then re-establish positions?

This isn’t about being right anymore – Provenge is approved and saving lives. This is about investing intelligently when one of the factors we have to deal with is an extra-legal force that has bought legal protection and maybe is bribing the judges.

[GuHu1]

Antwort auf Beitrag Nr.: 40.234.691 von Magnetfeldfredy am 29.09.10 19:53:03

provenge ist fda zugelassen.
ich betrachte das als letzten aber aussichtslosen versuch einfluß zu nehmen.
es gibt vorläufig nichts weiter als tax und provenge...... alle anderen zum teil hochgehandelten therapiekandidaten sind gescheitert alle!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.236.091 von GuHu1 am 29.09.10 22:24:43

Ja, Du hast Recht aber was den Kurs angeht wird das Panel erheblichen Einfluß nehmen, positves Panel ohne Label = alte Höchststände, on Label = Einbruch! Nur meine Meinung aber ich trau den Halunken ein Label zu, daß Dendreon`s Sharepreis einbrechen läßt!

[edelupolino]

Antwort auf Beitrag Nr.: 40.218.906 von GuHu1 am 27.09.10 19:59:37

Hi GuHu und Fredy et al,
"Astra Zeneca... fails...": diese nachricht könnte uns zeigen, wieso noch ne menge "big guys and gals" reinwollen -und das natürlich zu günstigeren kursen als im moment.
Wer auf das falsche pferd gesetzt hat, muss versuchen, die "gewinneraktie" (unsere) schlecht zu reden, als zu teuer abzuqualifizieren, die sich nur ein paar Milliardäre leisten können.
Und da an der börse fast IMMER unsicherheit herrscht (besonders bei biotechs), könnte die strategie wieder aufgehen. Trotz guter preisvergleiche ,die z.B. die dauer der medikation berücksichtigen, wird voller absicht suggeriert, Provenge sei unbezahlbar!

Ich jedenfalls habe wieder trockenes pulver in reserve und werde bei einbrüchen aufstocken!

Ciao Ede

[GuHu1]

hi ede,

anbei die situation eines der besten quellen aus dem village:
http://www.investorvillage.com/smbd.asp?mb=971&mn=371954&pt=…

Please, let me again address this situation. I corresponded with Ocyan after the incidents. Yes, there were some hurt feelings with some folks from IV. Yes, there was some bullying and some over the top sort of brow beating going on. But, that wasn't the real issue that drove Ocyan off of IV.

Apart from his participation, someone from anyone of a few of Ocyan contacts through the internet tracked him down through the internet, got hold of his personal information and hacked his identity and did some very harmful things to his personal identity. It got very onerous and caused some damage to the family members as well. Ocyan is not sure if it is a person from IV or one of the other involvements with the internet. They will leave that to the FBI to resolve. The incidents were criminal in nature and not brow beating and bullying in nature. There were fraudulent transactions involved and other criminal behaviors involved that I won't go into. Ocyan at the time wasn't sure the source of the individual's information. It could have even been a random hacking of information. It appeared professional in some ways. The authorities requested that Ocyan immediately drop ALL internet involvement as the thieves might tap into the contacts and secretly jump into message boards and discover other individuals.

Yes, the FBI and the service providers were hot in pursuit of the perpetrators that hurt this individual. This sad situation points out something we all know but seemingly have to be reminded about on occasion... namely, while we are anonymous to each other, nefarious individuals can crack this veneer rather quickly and can do damage easily. You need to change passwords periodically, and be sure you maintain recommended security measures with your brokerage accounts up to date.

Please, we are all in this together. We all feel badly for Ocyan. The situation is sad. Bullying is just a small piece of the puzzle and might have given a nefarious person the idea that this person was a mark. Please be kind to each other and maintain clean streets within the village. One or two individuals can't do it.

I wish everyone here profits and security and peace of mind. Good luck.

Fordwill1953

[edelupolino]

Antwort auf Beitrag Nr.: 40.254.744 von GuHu1 am 03.10.10 00:02:36

Hi GuHu,
dieser IV-bericht über internetverbrecher, die (im auftrag von wem???) hinter Ocyan her spionierten, passt ins bild, das man sich leider im laufe der zeit über viele ereignisse und übelste aktionen machen musste, die auch gegen Dndn gerichtet waren.
Dabei ist das bekannte wort vom "haifischbecken" noch untertrieben: haie töten, wenn sie fressen müssen, shorts und andere verbrecher (nur?) aus geldgier.
Unglaublich, dass das FBI eingeschaltet werden muss, weil ein sehr sachlicher und kenntnisreicher Mensch (Ocyan) sein Wissen an die mitglieder eines "board" weitergibt.
Ich vermute, dass rachsucht o.ä. im spiel ist, denn SEHR VIELE werden ihre aktien NUR WEGEN Ocyan nicht zu 1-3 $ verkauft haben!
Ciao Ede

[GuHu1]

Antwort auf Beitrag Nr.: 40.255.280 von edelupolino am 03.10.10 11:48:58

http://www.lef.org/magazine/mag2010/nov2010_FDA-Delay-of-One…

[edelupolino]

Antwort auf Beitrag Nr.: 40.255.346 von GuHu1 am 03.10.10 12:20:35

Schöner beitrag!
...im artikel steht was von "needless over-regulation"; es war aber bestechung und geldgier in übelstem ausmaß, die keine ehrfurcht vor den letzten monaten/wochen von patienten kennt.

PS vgl auch die von den US ausgegangene Finanzkatastrophe (keine ehrfurcht/respekt vor anderen menschen und ihren arbeitsplätzen)

[edelupolino]

Antwort auf Beitrag Nr.: 40.256.302 von edelupolino am 03.10.10 19:40:03

interessanter chart bei IV:
http://www.investorvillage.com/smbd.asp?mb=971&mn=372453&pt=…

und eine meinung, dass die US politiker schwierigkeiten von ihren alten wählern bekommen könnten, wenn Provenge weitere knüppel in den weg gestellt werden:
http://www.investorvillage.com/smbd.asp?mb=971&mn=372456&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.279.773 von edelupolino am 07.10.10 10:06:00

Servus Ede,

Du weißt, ich bin ein überzeugter Dendrone aber ich trau mich bis zur CMS Entscheidung nicht wieder rein, diese "Chemoschweinelobby" wird wieder alles versuchen um Provenge schlecht zu reden....

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.289.894 von Magnetfeldfredy am 08.10.10 15:32:28

Wow, geiler Pullback, hätte ich heute nicht gedacht freut mich für alle Investierten und einmal Dendreone immer Dendrone, Tenbagger unvergeßlich!

[GuHu1]

http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher…

[GuHu1]

http://www.investorvillage.com/mbthread.asp?mb=971&tid=96886…

Oct 27, 2010 2:17:00 PM

MARINA DEL REY, Calif., Oct. 27 /PRNewswire/ --

Prostate Oncology Specialists, Inc. of Marina del Rey is among the first sites in the nation to treat advanced prostate cancer patients with PROVENGE® (sipuleucel-T), the first in a new therapeutic class known as autologous cellular immunotherapies. PROVENGE was approved by the U.S. Food and Drug Administration (FDA) for the treatment of men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer and is made by Dendreon Corporation.
(Photo: http://photos.prnewswire.com/prnh/20101027/SF89964)

(Photo: http://www.newscom.com/cgi-bin/prnh/20101027/SF89964)

"PROVENGE is a scientific breakthrough that paves the way for similar personalized treatments in other cancer types," said Dr. Mark Scholz, Medical Director of Prostate Oncology Specialists and co-founder of the Prostate Cancer Research Institute. "I'm pleased to have a new option to present to my patients and to be a part of the first physician-based facility in the area treating patients with this important new FDA approved therapy."

Prostate Oncology Specialists have treated over 30 patients with PROVENGE to date, and anticipates providing the therapy to many more men with metastatic castrate resistant prostate cancer as supply of the drug increases over the next six months.

"I was excited about using PROVENGE because it allowed me to use my own cells to help fight cancer," said PROVENGE patient Frank La Barba of Long Beach, CA. "My side-effects were mild and following my treatment, I was able to get back to doing the activities I did before receiving therapy, such as traveling and photography."

PROVENGE is an autologous (made from a patient's own immune cells) cellular immunotherapy designed to stimulate a patient's immune system to identify and target prostate cancer cells. Each dose is manufactured specifically for each patient using his immune cells.

The Centers for Medicare and Medicaid Services are currently undergoing a National Coverage Analysis (NCA) regarding autologous cellular immunotherapy treatment of metastatic prostate cancer. As part of the NCA process, Dr. Scholz will provide an expert opinion on PROVENGE data at the November 17th Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting in Baltimore, MD.

In addition, Dr. Scholz will be giving a presentation on the latest developments in treating advanced prostate cancer, including new immunological approaches such as PROVENGE and effective chemotherapy combinations, at an UsTOO educational session in Fullerton, CA on Thursday, October 28th beginning at 5 p.m. PT. For press attendance credentials or information on location for patients, please contact Lew Pfeffer at [phone].

PROVENGE Safety

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

The most common adverse events (incidence >15%) reported in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Please see full Prescribing Information for PROVENGE at www.provenge.com.

About Prostate Cancer

According to the American Cancer Society, prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than two million men in the United States have prostate cancer, with an estimated 217,730 new cases and approximately 32,050 men expected to die from the disease in 2010.

Individuals interested in learning whether PROVENGE is an appropriate treatment option should contact Jennifer Leung at [phone], extension 32 or Dendreon On-Call at [phone]. For full Prescribing Information, please visit www.PROVENGE.com.

About Prostate Oncology Specialists, Inc.
Established in 1995, Prostate Oncology Specialists has earned national acclaim for its comprehensive approach to prostate cancer prevention and management. Under the direction of Medical Director, Mark Scholz, M.D., Prostate Oncology Specialists employs a highly-skilled team of physicians trained in oncology, hematology and internal medicine. Prostate Oncology Specialists are not wedded to any single therapy for prostate cancer, but rather advocate the exploration of treatment options that are customized and tailored to the unique needs of each individual patient. Prostate Oncology Specialists' ongoing mission is to uncover new medical breakthroughs in the treatment and management of prostate cancer.

About Prostate Cancer Research Institute

PCRI is a 501(c)(3) not-for-profit education and research organization founded in 1996 by Mark Scholz, M.D. and Stephen Strum, M.D.. The PCRI educates patients and their families about prostate cancer. This includes new advances in diagnosis, staging, treatments and available resources. PCRI believes that a patient who understands his disease and treatment is empowered to communicate more effectively with his physicians and obtain a better outcome. PCRI intends to use all available communication tools to accomplish this most important objective.

RELATED LINKS

provenge.com

prostateoncology.com

pcri.org

SOURCE Prostate Oncology Specialists, Inc.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.403.808 von GuHu1 am 27.10.10 22:46:03

Hört sich doch gut an, wenn dieser blöde CMS Termin am 17. Nov. nicht wäre!

Was glaubst Du GuHu1 kommt raus, ich denke es wird sich nichts ändern, Dendreon darf für den zugelassenen Prostatakrebs weiter behandeln aber braucht für andere Prostatakrebsformen Studien die das Überleben bestätigen, oder?

Würde sich natürlich nicht besonders positiv auf den Kurs auswirken, on label, oder?

[GuHu1]

Antwort auf Beitrag Nr.: 40.405.301 von Magnetfeldfredy am 28.10.10 10:00:36

blockbuster potential für on label, meine meinung.
übrigens kann dndn derzeit die nachfrage nicht abdecken, da die vollen kapazitäten erst 2011 zur verfügung stehen.
ausbau von nj und aufbau zweier weiterer produktionsstätten, ich meine das entspricht einer erweitert von 12 auf 120 produktionsplätzen.
und das alles nur usa!

mal schaun was die q zahlen am 03.11. bringen.

auch ganz nett:

http://search.lef.org/cgi-src-bin/MsmGo.exe?grab_id=0&page_i…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.411.368 von GuHu1 am 28.10.10 21:24:25

Guter Artikel, schau ma moi wos am 17.11.2010 rauskommt!

[GuHu1]

http://www.bio.org/pdfs/BIOs_Immunotherapy_NCA_Comments_7-30…

http://blogs.forbes.com/matthewherper/2010/10/29/is-provenge…

http://www.investorvillage.com/smbd.asp?mb=971&mn=374967&pt=…

[GuHu1]

lesenswert:

http://www.johnshopkinshealthalerts.com/alerts/prostate_diso…

Johns Hopkins Health Alert
Provenge – A Novel Prostate Cancer Vaccine

In this excerpt of an article in our Health After 50 newsletter, Charles Drake, M.D., Ph.D., associate professor of oncology, immunology, and urology at Johns Hopkins and a world-renowned expert on cancer vaccines, discusses sipuleucel-T (Provenge) – a novel approach for prostate cancer.

With the recent U.S. Food and Drug Administration (FDA) approval of the prostate cancer vaccine Provenge, the war against prostate cancer has taken a promising turn. The vaccine is approved for men with advanced prostate cancer that is asymptomatic or minimally symptomatic, has spread beyond the prostate, and has failed to respond to hormone deprivation therapy. This therapy suppresses hormones that fuel the growth of prostate cancer cells.

Clinical trials show that men with this type of advanced prostate cancer who were given Provenge lived for approximately 25.8 months afterward. The men who didn’t receive the vaccine lived for 21.7 months.

Provenge extended life by about four months. Were the researchers hoping for more? While four months may not be the home run that all of us would like to have seen, if you put these results into context, it really is a very significant achievement for several reasons.

•First, the men in this study had metastatic prostate cancer that did not respond to hormone deprivation therapy. For this type of cancer, treatment options are very limited. The chemotherapy drug docetaxel is the only other FDA-approved treatment for men in this advanced stage of the disease and clinical trials show that docetaxel extends life by approximately two months.

•Second, Provenge is the first FDA-approved vaccine to treat cancer. (The human papillomavirus [HPV] vaccines help prevent cervical cancer, but they don’t treat it.) Its approval opens doors for other companies to come forward with cancer vaccines and for Provenge eventually to be made available to men with less advanced prostate cancer, for whom we think the vaccine will be even more effective.

How does this vaccine differ from vaccines for immunization? Vaccines for immunity prevent disease by introducing a small portion of a virus or bacterium to the immune system before you become infected. That way, if you are exposed, you will have already produced antibodies to fight the infection and chances are you won’t become ill. Or, if you do become ill, you will be sick only for a short time.

Unlike vaccines for immunization that prevent disease, vaccines for prostate cancer are immunotherapies [targeting existing tumor cells]. They are therapies in the same sense that chemotherapy is a therapy. Because people with prostate cancer already have the disease (and have usually had it for five to 10 years) the trick is to activate the immune cells to fight it. The process is a lot more involved than immunization-type vaccines because the immune system has already seen the cancer and has grown complacent.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.424.331 von GuHu1 am 31.10.10 19:09:40

Dendreon: Third Quarter Earnings Preview
By Adam Feuerstein 11/01/10 - 11:40 AM EDT Add Comment
Stock quotes in this articleNDN

SEATTLE (TheStreet) -- Dendreon(DNDN_) will provide investors with another Provenge sales update when the company reports third quarter results Wednesday.
More from Adam Feuerstein
FDA Ends October With Drug Approvals, RejectionHep C Update: Vertex, Merck and GileadFDA Approves Avanir DrugMarket Activity
Dendreon Corporation| DNDN UPAnalysts, on average, are expecting Provenge sales of just under $24 million. Dendreon is expected to post a net loss of 44 cents a share in the quarter, according to Thomson Reuters. Dendreon's third-quarter report comes just two weeks before the U.S agency in charge of Medicare and Medicaid convenes a panel meeting to assess the use of Provenge in prostate cancer patients. Dendreon shares have been volatile going into this panel meeting because of concerns that Medicare officials could decide to restrict or limit reimbursement of Provenge.
The U.S. Food and Drug Administration approved Provenge on April 29. Provenge is the first cancer drug approved that works by activating a patient's own immune system to fight the disease. Yet the Provenge launch isn't typical since Dendreon can't make enough to satisfy patient demand. The company long ago told investors that limited manufacturing capacity would only allow about 2,000 patients to be treated in the first 12 months of the launch.
On Wednesday, Dendreon is expected to update investors on the progress being made to expand its New Jersey manufacturing plant and build out two new plants in Atlanta and Orange County, Calif., respectively. Dendreon is expected to be at full manufacturing capacity for Provenge in the middle of 2011.
Dendreon should also offer an update on the number of prescriptions written for Provenge. In August, the company said doctors wrote 500 Provenge prescriptions in the first three months of the drug's launch, which signaled strong demand for the drug.
Dendreon shares were up 21 cents to $36.71 in Monday trading.
--Written by Adam Feuerstein in Boston.

>To contact the writer of this article, click here: Adam Feuerstein.
>To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein.

[GuHu1]

Antwort auf Beitrag Nr.: 40.429.872 von Magnetfeldfredy am 01.11.10 17:03:06

das sind 5 seiten....

http://www.gekkowire.com/?p=5475

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.431.877 von GuHu1 am 01.11.10 21:20:42

Bin mal wieder mit einer Placebo Position von 200 Stück eingestiegen, die Zahlen, der Ausblick....reizt!

[GuHu1]

Antwort auf Beitrag Nr.: 40.447.048 von Magnetfeldfredy am 03.11.10 17:51:30

na dann, alter recke, glück auf.

http://dendreon-opinion.com/2010/11/indian-oncologist-lauds-…

[GuHu1]

http://www.cleveland.com/healthfit/index.ssf/2010/11/2010_in…
CLEVELAND, Ohio — A radioactive dye that can detect and highlight brain plaques that signal Alzheimer's disease is the medical innovation of the year, chosen from more than 90 candidates by physicians at the Cleveland Clinic.

The top 10 medical innovations for 2011, to be announced this morning at the Clinic's eighth annual Innovation Summit, includes groundbreaking drugs for cancer, hepatitis and multiple sclerosis, as well as technical innovations like incision-less bariatric surgery.

The Summit, in its third and final day today, was expected to draw more than 1,000 health care leaders from across the country to discuss innovations in treating obesity and diabetes.

In the spring, more than 60 physicians at the Cleveland Clinic nominated innovations they felt would change the face of medicine. Since then, they narrowed the field several times, focusing on drugs and devices that could show a significant potential for patient benefit or improved health care delivery, a high probability of success and good quality data to support its nomination.

Nominees must have Food and Drug Administration approval, or a great chance of approval by early 2011.

Here are the Top 10:


1. Molecular imaging biomarker for early detection of Alzheimer's Disease: A new brain imaging compound called AV-45 will soon make it possible to detect the very earliest stages of the brain damage caused by Alzheimer s, and is expected to become the dominant way to diagnose the disease.

2. Targeted T-cell antibody for metastatic melanoma: A new anti-cancer drug, ipilimumab, allows the body s own immune system to more effectively fight cancer. It was given priority review by the FDA after it improved the survival rates of patients with previously treated advanced melanoma.

3. First cancer vaccine approved by the FDA: Provenge (Sipuleucel-T), the first cancer vaccine to show a survival benefit, is a prostate cancer treatment that works by stimulating the immune system. Its April approval means it will likely be available for use earlier in the treatment process.

4. Jupiter Study: Statins for healthy individuals: Through a large international study, researchers have found that cholesterol-lowering drugs called statins drastically cut the risk of heart disease and death for people with normal levels of cholesterol but elevated levels of inflammation.

5. Hepatitis C protease inhibiting drugs: Two drugs awaiting approval, boceprevir and telaprevir, were developed specifically to target the hepatitis C virus and have shown a vast improvement over the cure rates of existing treatments.

6. Telehealth monitoring for individuals with heart failure: An implantable, miniature, permanent monitor that can measure and communicate daily pulmonary artery pressure, as well as in-home devices that record and send real-time weight, blood pressure and heart rate data are allowing for closer monitoring of costly medical conditions, potentially reducing hospitalization.

7. Endoscopic weight-loss procedure: Transoral Gastroplasty (TOGA). An incision-less option for bariatric surgery, TOGA uses two flexible endoscopes to pass instruments through the mouth, reducing the size of the stomach to a small pouch.

8. Exhaled nitric oxide (NO) breath analysis for diagnosing asthma: A hand-held diagnostic testing device that allows precision and accuracy in diagnosing and managing asthma, the device measures levels of exhaled nitric oxide, a gas produced by cells in the lungs during inflammation.

9. Oral disease modifying treatment for multiple sclerosis: Fingolimod, approved this year by the FDA, is the first oral treatment available to MS patients, a major breakthrough in treatment that reduced attacks and brain lesions in clinical trials.

10. Capsule endoscopy for diagnosis of pediatric GI disorders: A safe and painless alternative to endoscopic imaging and X-rays, the pill-sized capsule takes hundreds of pictures and short video clips of the inside of the digestive tract and transmits them to a data recorder during transit.

Go to clevelandclinic.org/innovations for more information on the summit and the Clinic's top 10.

[GuHu1]

http://www.thestreet.com/_yahoo/story/10910659/1/dendreon-pr…

SEATTLE (TheStreet) -- Dendreon(DNDN_) reported third quarter Provenge sales of $20.2 million and forecast 2011 sales that are short of Wall Street's consensus estimates.
More from Adam Feuerstein
Cadence: When A Drug Approval Sinks StockDendreon: Third Quarter Earnings PreviewFDA Ends October With Drug Approvals, RejectionMarket Activity
Dendreon Corporation| DNDN UPProvenge, a prostate cancer immunotherapy, was launched in May but sales are constrained because Dendreon is operating a single manufacturing plant at less than full capacity and still building two others. Dendreon has told investors that about 2,000 patients would be treated with Provenge in the first 12 months of the launch and that manufacturing would reach full capacity in the middle of 2011.
Dendreon said Wednesday it expects 2011 revenue in the range of $350 million to $400 million, with half of that to be generated in the fourth quarter.
The new guidance is below the Street's current consensus revenue estimate of $402 million, which suggests either analysts are over-reaching or Dendreon is being conservative.
The $20.2 million in Provenge sales for the third quarter fell about $4 million short of expectations, although monthly sales grew each month during the quarter and in October, Provenge sales were $9.5 million, the company said.
Doctors have written about 1,000 prescriptions for Provenge since the drug was launched, the company added. That's double the number of Provenge prescriptions reported by Dendreon on its second-quarter conference call.
"We’re pleased with the progress we have made in the first six months of the launch of Provenge," said Dendreon CEO Mitch Gold, in a statement.
For the September quarter, Dendreon reported a net loss of $79.3 million, or 56 cents a share, which includes a charge for a litigation settlement equal to 9 cents a share. In the prior September quarter, Dendreon lost $45.6 million, or 40 cents a share.
Dendreon shares closed Wednesday at $38.59 but were down 5% to $37 in the after-hours session.

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=375629&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.450.045 von GuHu1 am 03.11.10 23:21:44

Ich hab nach dem CC gestern wieder meine Placebo Position für EUR 27,00 verkauft, Provenge wird seinen Weg machen aber viele Hindernisse und die sehr hohe Marktkapitalisierung, 5 Milliarden Dollar, lassen mich zur Zeit zweifeln.

[GuHu1]

http://www.xconomy.com/seattle/2010/11/03/dendreon-hemmed-i…

http://www.investorvillage.com/smbd.asp?mb=971&mn=375686&pt=…

[GuHu1]

http://www.minyanville.com/businessmarkets/articles/provenge…

[GuHu1]

http://www.minyanville.com/businessmarkets/articles/dendreon…

[GuHu1]

http://finance.yahoo.com/news/Dendreon-Submits-PostApproval-…

Press Release Source: Dendreon Corporation On Wednesday November 10, 2010, 5:00 pm
SEATTLE, Nov. 10, 2010 /PRNewswire-FirstCall/ -- Dendreon Corporation (NasdaqNDN - News) today announced that it has completed the submission of the post-approval supplement to the PROVENGE® (sipuleucel-T) Biologics License Application for the Morris Plains, New Jersey manufacturing facility. Dendreon is requesting licensure for an additional 36 workstations to manufacture PROVENGE. The standard U.S. Food and Drug Administration (FDA) review for a post-approval supplement to a Biologics License Application is typically four months.

"The submission requesting licensure for additional capacity of the New Jersey manufacturing facility is an important milestone as we work to make PROVENGE more widely available to the many patients who may benefit from it," said Mitchell H. Gold, M.D., president and chief executive officer.

Dendreon's manufacturing facility in Morris Plains, New Jersey is currently operating at 25 percent capacity, with 12 workstations available to manufacture PROVENGE. With the FDA approval of the post-approval supplement to the Biologics License Application, the facility will have a total of 48 workstations. PROVENGE is the first in a new therapeutic class known as autologous cellular immunotherapies.

[crivit]

UPDATE 2-'Moderate' evidence backs Dendreon vaccine-US CMS

* Medicare agency releases assessment on Provenge

* Data shows 'moderate' support for approved use

* Medicare advisers to weigh cancer vaccine next week

* Industry analysts take positive view

http://www.reuters.com/article/idCNN1022424520101110?rpc=44

[GuHu1]

http://www.pharmalot.com/2010/11/the-provenge-vaccine-and-th…

ocyan
•November 11th, 2010
•11:30 am
•Link to this comment
Sigh… Too much misreading of the Technical Assessment document. The authors of the TA were very clear that their rating of “Good”, “Moderate” and “Poor” included whether or not additional data could change the magnitude of the measured survival benefits and was not just about whether Provenge has been satisfactorily proven to confer survival benefits on treated patients.

Their definition of “Moderate” says this:

“Moderate confidence that the evidence reflects the true effect. Further research may change our confidence in the estimate of effect and may change the estimate.”

That is a fine assessment of data from trials with a protocol that allowed crossing over to both Frozen Provenge and other treatment forms. Of course, the measured survival benefits were not as clear as possible if only pure placebos were allowed. The TA document itself observed: “If the cross-over treatment has a treatment effect in the same direction as the original treatment, then in most cases a conservative bias would result, so that the usual intention-to-treat analysis of the trial would result in a conservative estimate of treatment effect.”

Now, consider the combined data from the D9901 and D9902a trials in which all patients were followed for three years. There were 12 survivors on the control arm at three years. Of those, 10 crossed over to take Frozen Provenge and only 2 were pure placebos. There should be no question there that Frozen Provenge was effective. It just was not as effective as the fresh Provenge given to patients on the treatment arm.

So, the median survival benefits measured from the trials were conservative as the TA authors observed. The trial results would have been better if no crossing over to Frozen Provenge was allowed. Of course, that would also mean that patients on the control arms of the trials would be denied a chance at life. No ethical trial designers would do that.

The FDA and Dendreon people who worked together on designing the Provenge trials saw through all such ethical issues. The FDA then granted Dendreon a Special Protocol Assessment for the IMPACT trial.

At this time, there should be no question whatsoever that Provenge works and that it has passed the most stringent scientific tests to prove it!

[EvertonFC]

Hallo zusammen

Im Zuge des Research zu Dendreon bin ich auf eine andere Aktie gestossen, die ihr euch vielleicht mal anschauen solltet.

AAstrom Biosciences (ASTM) verfügt über eine auf eine Technologie der Zellvermehrung, die sich aber auf körpereigene Stammzellen und ganz andere Indikationen konzentriert.

ASTM hat trotz nideriger Marktkapitalisierung eine absolute Alleinstellung. Die Phase 2 Daten sehen bisher sehr sicher aus. Am Don. veröffentlicht man die letzten Phase 2b Daten.

Wenn mich mein Research nicht täuscht könnte Aastrom eine ähnlich legendäre Entwicklung bevorstehen wie Dendreon wobei die Dulition geringer und das Marktpotential ungleich höher ist.

Für die Indikationen DCM und CLI gibt es bisher kein Medikament. Analysten sprechen von 3 Mrd. Umsatz bei einer konservativen Durchdringung von 10% der Patienten nur in den USA.

Man hat bereits fast track von der FDA und die Chance bald die Marketing-Zulassung für die no option Patienten zu erhalten. Dazu müssen die restlichen Daten der Phase 2B die bisherige Sicherheit bestätigen.

Nun habe ich genug geschwärmt, am Ende müssen die Studiendaten dennoch stimmen, sonst nützt alles nichts. Anbei ein paar nützliche Links für die, die Lust haben sich einzulesen.

[EvertonFC]

http://seekingalpha.com/article/233027-aastrom-biosciences-g…

http://messages.finance.yahoo.com/Business_%26_Finance/Inves…

http://messages.finance.yahoo.com/Business_%26_Finance/Inves…

http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…

[edelupolino]

Antwort auf Beitrag Nr.: 40.525.824 von EvertonFC am 15.11.10 20:46:30

Hi EFC,
der chart (Feb 10) sieht ja ähnlich wild/erschreckend aus, wie es bei unserer schon öfter passierte !
Gibt es dazu hinweise? Wer schrieb schlecht über diesen wert? Wer shortete?

[EvertonFC]

Antwort auf Beitrag Nr.: 40.529.446 von edelupolino am 16.11.10 12:46:35

Offenbar einer dieser Bear Raids, die kürzlich auch AVNR kurz vor Zulassung durch die FDA zerrissen hat.

http://biomedreports.com/2010111660131/weak-bear-raid-sets-t…

Alternative Möglichkeit ist, dass ASTM kurzfristig neue Aktien nach dem Shelf Filing vom Freitag ausgibt. Das letzte Mal hatte man sich allerdings 3 Monate Zeit gelassen. Ich hoffe man wartet noch höhere Kurse ab, bis man wieder Geld aufnimmt. Im Januar komen die Studiendaten Phase 2 für die zweite Indikation. Im Moment noch 15 Mio.$ in der Bank. Die Zeichner gehen vorher short und verdienen. Deckung erfolgt durch gezeichnete Aktien.

Langfristige Chance bleibt von der ganzen Nervosität unbetroffen wenn Phase 2B die Daten zu Wirksamkeit & Sicherheit bestätigen kann.

Ich entschuldige mich schon mal, dass ich nicht speziell zu Dendreon geschrieben habe aber ASTM scheint in D noch nicht bekannt zu sein.

[GuHu1]

http://spectator.org/archives/2010/11/16/don-berwicks-death-…

Don Berwick's Death Panel?
By Robert M. Goldberg on 11.16.10 @ 6:08AM

Are Medicare director Don Berwick and the Obama administration delaying or denying patients access to medical innovations? That's a question the Senate's Finance Committee should ask Berwick, who heads up the Center for Medicare and Medicaid Services (CMS), when he testifies November 17.
The timing couldn't be better. Medicare won't pay for Provenge, the first cancer vaccine, since it was approved in April. It's waiting for the Medicare Coverage Advisory Committee (MEDCAC) -- also meeting on the 17th -- to decide whether the Food and Drug Administration, the National Cancer Institute, and cancer experts are right in supporting Provenge use for prostate cancer patients.
MEDCAC was established in 1998 so CMS could ask leading scientists and doctors to recommend what information should be collected to determine the best use of new technologies. But recently MEDCAC has -- under CMS direction -- begun evaluating whether innovations are cost-effective.
In November 2008 Medicare bureaucrats asked MEDCAC: At current Medicare prices, how confident are you that CTC has a similar ratio of cost per LYS (Life Years Saved) as optical colonoscopy? In 2009 CMS asked MEDCAC: What are the desirable measures of the cost-effectiveness of screening genetic tests for the prevention or early detection of illness or disability? By 2010 CMS was simply asking MEDCAC whether CMS should cover new technologies unless there was evidence of its cost and clinical effectiveness from long and expensive studies. As one speaker at a MEDCAC hearing about genetic tests noted, "if clinical outcomes as defined… become[] a requirement for reimbursement, it will reduce investment in new genetic tests and the market introduction of these tests, and ultimately their use. "
That's the goal. But given Provenge's high profile, asking about its cost-effectiveness would be controversial. Since the one-time treatment runs about $90,000, CMS thought it could ask if Provenge was effective without mentioning cost. Hence, Dr. Louis Jacques, the director of the Coverage and Analysis Group at Medicare, told Forbes: "We've been getting questions from people," says Jacques. "'Well, what's up with Provenge? Is it a drug? Is it a biologic? Is it something else? Does it really work? It has been interesting to look at the evidence around it."
Does it really work?!
Maybe Dr. Jacques didn't get the memo about the FDA approving Provenge. The FDA said Provenge "substantially improved survival to patients with a fatal disease. The risks… are minor relative to the benefit of improved survival." Or perhaps he didn't see the May 6 National Cancer Institute statement asserting: "The field of cancer immunotherapy received an important boost last week with the FDA's approval" of Provenge. On May 29 the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium added Provenge to its list of standard therapies. On June 15 Aetna said it would cover Provenge.
Federal law requires that CMS cover any cancer drug approved by the FDA or NCCN compendium therapy. Instead, on June 30, an anonymous individual requested that CMS hold a MEDCAD hearing on Provenge before it covered the drug. CMS immediately accepted the query from the secretive party. Perhaps the Finance Committee can find out who that was.
MEDCAC will render its decision based on a just released evaluation of the FDA data conducted by the Agency for Health Research and Quality (AHRQ). AHRQ tried to pretend it wasn't second-guessing the FDA and the NIH. In October, the report name was changed on AHRQ's website from "The Efficacy and Safety of Sipuleucel T" (Provenge) to "The Outcomes of Sipuleucel T." The reviewers determined the FDA data used to approve Provenge was "adequate" but not entirely convincing. You might wonder: What expertise in prostate cancer did the authors use to draw to that conclusion? The answer is none unless you count nursing, a master's degree in statistics, or a PhD in sociology. Apparently CMS believes AHRQ's collective wisdom towers over the oncology expertise of the FDA, NCI, and NCCN.
The AHRQ report understates the impact of Provenge on survival. First, it begrudges the fact that many patients receiving chemotherapy after taking Provenge live longer. It focuses on the median survival benefit of 4.5 months (which tells you the midpoint of patient survival but not how many patients lived longer and for how long). Then it raises doubts about safety. And finally the study glosses over the finding that terminal prostate cancer patients who received Provenge were 40 percent more likely to be alive in three years than those who did not receive it. The AHRQ report is ideology masquerading as medical facts. The routine and expanding using of AHRQ to guide life or death decisions undermines the legitimacy of real science.
MEDCAC meets this week but CMS can take months to decide. This callous and possibly illegal process reflects Berwick's stated belief that only a centralized entity should decide what's best for us. People with prostate cancer have died and will die waiting. If that's not a death panel, I don't know what is.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.534.266 von GuHu1 am 16.11.10 22:01:08

Servus GuHu1,

na, was kommt raus heute bei der "Verarschung", Zulassung und dann wieder Kostenübernahmepanel, peinlich, peinlich!

[barabo]

Antwort auf Beitrag Nr.: 40.535.116 von Magnetfeldfredy am 17.11.10 07:25:27

Mich würde es nicht wundern, wenn es bei der Kostenerstattung Probleme geben wird.
Das könnte dann deutlich auf den Kurs drücken.

[hakur]

Der Handel ist in USA ausgesetzt!
Gutes Vorzeichen? Mein Bauch und der Chart sagen Ja


http://www.nasdaqtrader.com/Trader.aspx?id=TradingHaltSearch…

[brazzo007]

hi,

weiß einer wann der Markt wieder offen ist?? bzw. wenn neue news da sind ??

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.538.863 von brazzo007 am 17.11.10 16:01:47

Ich denke heute wird es nichts mehr, vielleicht nachbörslich an der Nasdaq und morgen bei uns?
Ich bin ja so gespannt wie verärgert!

[crivit]

Antwort auf Beitrag Nr.: 40.538.021 von hakur am 17.11.10 14:28:10

Na hoffen wir es mal!
GLTA

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.540.892 von crivit am 17.11.10 19:31:45

Doctors, users back Dendreon vaccine for Medicare

ShareretweetEmailPrintCompanies:Aetna Inc.Dendreon Corp.Humana Inc. Related Quotes
Symbol Price Change
AET 30.37 0.00

DNDN 35.87 0.00

HUM 58.26 +0.69

TRI 36.46 -0.33

TRI.TO 37.29 -0.41


{"s" : "aet,dndn,hum,tri,tri.to","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} On Wednesday November 17, 2010, 1:19 pm

* Vaccine approved to treat prostate cancer



* Nationwide coverage for $93,000 therapy at issue



* Medicare panel to offer agency advice



* Sales seen reaching nearly $2 billion by 2014



* CMS to make initial decision by end of March 2011



By Susan Heavey



WASHINGTON, Nov 17 (Reuters) - Patients, doctors and the company that makes a prostate cancer vaccine all urged U.S. Medicare advisers on Wednesday to support their pleas to have federal insurance pay for Dendreon Corp's (DNDN.O: Quote, Profile, Research, Stock Buzz) therapy regardless of its hefty price tag.



The Medicare advisory panel is weighing the evidence for the expensive therapeutic vaccine, called Provenge, and whether the government should pay for it under the nation's health insurance program for the elderly or disabled.



Centers for Medicare and Medicaid Services (CMS) officials will take the panel's advice into account in making a final ruling, expected next year.



The decision is not only critical for patients but also Provenge sales, which could reach $1.9 billion by 2014, according to data from Thomson Reuters (TRI.N: Quote, Profile, Research, Stock Buzz) (TRI.TO: Quote, Profile, Research, Stock Buzz).



"This is a new agent that is clearly beneficial for patients," said Dr. Mark Scholz, a California-based prostate oncologist and one of nearly two dozen speakers urging Medicare's support.



Most analysts expect Medicare to pay for Provenge even if additional data were sought, a move that could also encourage private insurers to follow suit.



Aetna Inc (AET.N: Quote, Profile, Research, Stock Buzz), Humana Inc (HUM.N: Quote, Profile, Research, Stock Buzz) and several other health insurers have already agreed to pay for the vaccine, which does not prevent cancer but fights the tumors, according to a company spokesman.



Provenge was approved for the U.S. market in April to treat men with advanced prostate cancer after company data showed it help men live another 4.1 months on average.



It costs $93,000 for three infusions given over the course of one month. While many cancer therapies are also expensive, their costs are spread out over more time or are stopped when they do not seem to be helping.



Dendreon says the high price reflects a unique manufacturing process that takes cells from a patient's tumor, mixes them with some of the patient's own immune cells and then infuses the immune cells back into the patient.



Unlike traditional vaccines that prevent disease, Provenge stimulates the body's immune system to attack malignant cells.



REASONABLE AND APPROPRIATE



Dendreon Chief Medical Officer Mark Frohlich told the panel the therapy, also known as sipuleucel-T, is one of few available options that actually helps patients live longer with fewer side effects, providing "an important new treatment."



While the Food and Drug Administration approved Provenge as safe and effective, CMS is deciding whether its use is "reasonable and appropriate." By law, it cannot consider the vaccine's cost in making its decision.



Still, there are larger financial concerns for Medicare, and patients have worried that the therapy's price was an unspoken stumbling block, especially since most men with prostate cancer are older and are covered by the program.



Medicare covers roughly 45 million Americans -- 40 percent of whom are men -- but faces possible insolvency and was recently targeted for major cuts by a U.S. deficit panel [ID:nN10200961].



"One has to wonder if today's meeting is indeed about something other than the science, namely the cost," said Brad Loncar of Kansas, whose grandfather had the disease. "It's very concerning."



Laurel Todd, the head of reimbursement and health policy for the Biotechnology Industry Organization industry group whose father had prostate cancer, said: "There should be no question that an FDA-approved therapy should be covered by Medicare for patients and conditions indicated on its label."



Nearly 218,000 U.S. men will be diagnosed with prostate cancer this year, according to he government's National Cancer Institute, although not all those men will either qualify for Provenge or be enrolled in Medicare.



CMS has said it is only looking at clinical data in weighing Provenge. The panel's chairman, Lewin Group Senior Vice President Clifford Goodman, noted the agency in the past has declined to pay for FDA-cleared drugs and devices but has also covered other, experimental ones not yet approved.



Shares of Seattle-based Dendreon have fallen nearly 38 percent from a year high in the wake of FDA's Provenge approval, in part over concerns about the product's launch.



Its shares were halted on Wednesday ahead of the Medicare advisers' votes.



The agency will factor in the panel's recommendations in making its proposed payment decision, expected by March 30. A final decision is due by the end of June. (Reporting by Susan Heavey. Editing by Gerald E. McCormick)


Follow Yahoo! Finance on Twitter; become a fan on Facebook.

[hakur]

hier ein Beitrag auf YAHOO von japanjimmyd1,
klingt doch sehr ermudigend.
Japanjimmyd1 ist ein über sehr lange Zeit wichtiger , sehr informierter und geachteteter Poster auf IV

so loooong

http://www.investorvillage.com/smbd.asp?UseArchive=&v=1&cate…


CMS looking really bad, some heads will roll at CMS for this

Harvard M.D.s, NEJM publications, and numerous leading experts in oncology all speaking with absolute clarity and confidence about the unprecedented positive results for Provenge, but the CMS official who conducted the shoddy Technology Assessment speaks with zero confidence in his assessment. This is real embarrassment for CMS and a total win for Dendreon. Provenge is a medical breakthrough and everyone at this meeting knows it. Panel is now not even addressing questions to this CMS representative as he can't even answer the questions w/o a 5 minute ramble. This is a clear and total win for Dendreon. Its giving Dendreon a perfect stage to highlight just how impressive the survival results are, and now we have new evidence, soon to be published indicating that the trials actually underestimated the survival benefit! Stock is going to soar. Overall survival is going to be shown to be even greater than this already unprecedented positive result.


http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_D/t…[/url]

[GuHu1]

Antwort auf Beitrag Nr.: 40.540.957 von hakur am 17.11.10 19:40:04

@all lest im iv, die berichten online, ist schwer das alles auseinander zu puzzeln
user saulk will auch eine zusammenfassung reinstellen, hab ich jedenfalls so im kopf.

http://www.investorvillage.com

[GuHu1]

Antwort auf Beitrag Nr.: 40.541.495 von GuHu1 am 17.11.10 20:39:58

CMS moderator is now trying to provide excuses to CMS as to why this silly mtg is taking place

He's an apologist for the CMS. He keeps trying to get BC/BS guy to say that the published and existing data was obscure and difficult to understand and that therefore CMS is justified for requesting the TA and this meeting. But BC/BS guy won't take his bait! and thankfully other doctors have chimed in and said that published data is clear, concise and very far from obscure i.e. this TA was absolutely not necessary. CMS moderator is trying to supply excuses on behalf of CMS as to why this technology assessment and this Medcac was required. What an embarrassment for the CMS.

http://www.investorvillage.com/mbthread.asp?mb=971&tid=97745…

[GuHu1]

Now let's get on the phone to our Congress members
There is no need to keep the on-label reimbursement for Provenge in limbo until March. As several people stated today, patients and doctors are totally confused about whether or not to get themselves into the waiting list for Provenge because of this CMS indecision. This is affecting patients right now, this very moment, because of this CMS decision to review the evidence for the labeled indication. CMS has everything they need NOW to release a statement saying the labeled indication will be reimbursed now. If they want to dither about the off-label use, then let them do this for 3 months and get back to us in March. Ask your Congressman to contact CMS and ask for a statement NOW from CMS for reimbursement of the labeled indication.

http://www.investorvillage.com/smbd.asp?mb=971&mn=378562&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.541.539 von GuHu1 am 17.11.10 20:47:45

Dendreon’s Provenge Survival Data is Adequate, U.S. Panel Says
By Catherine Larkin - Nov 17, 2010 8:27 PM GMT+0100 Tweet LinkedIn Share
Business Exchange Buzz up! Digg Print Email Dendreon Corp. has shown adequate evidence to determine whether its prostate cancer drug Provenge improves survival, according to a U.S. panel helping the government decide whether to pay for the $93,000 treatment.

Outside advisers to Medicare, the health insurance program for the elderly and disabled, expressed confidence in the quality of the Provenge data at a meeting today in Baltimore. The panel will vote next whether they think the drug does help men with advanced prostate cancer live longer.

To contact the reporter on this story: Catherine Larkin in Baltimore at [e-mail].

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 22.548.805 von Cyberhexe am 12.07.06 20:06:33

Dendreon Wins Medicare Panel's Backing That Provenge Helps Cancer Patients
By Catherine Larkin - Nov 17, 2010 8:49 PM GMT+0100 Tweet (1)LinkedIn Share
Business Exchange Buzz up! Digg Print Email Dendreon Corp. won the backing of an advisory panel helping the U.S. government decide whether to pay for its $93,000 prostate cancer treatment.

Outside advisers to the Medicare health plan said today they were confident that Dendreon’s Provenge “clinically significantly” improves survival in men with advanced prostate cancer. Medicare, the U.S. insurance program for the elderly and disabled, will take the recommendations into account in a coverage proposal due by March 30 and a final decision in June.

Seattle-based Dendreon won Provenge approval in April based on a study showing a four-month survival benefit. Three-quarters of patients approved for the drug also qualify for Medicare, making next year’s reimbursement decision critical for sales. Provenge may bring in $1.75 billion in 2014 with Medicare coverage, according to the average estimate of four analysts surveyed by Bloomberg.

“It improves survival without the additional adverse reactions that are known with some of the other cancer therapies,” panel member Karl Matuszewski, a pharmacology expert and editor for Reed Elsevier NV health publications, said today at the meeting in Baltimore. “This is really another option.”

Dendreon shares are up 36 percent this year even after having fallen 28 percent since Provenge’s approval on April 29 because of reimbursement and supply concerns. Trading on the stock was halted today on the Nasdaq Stock Market.

To contact the reporter on this story: Catherine Larkin in Baltimore at [e-mail].

To contact the editor responsible for this story: Reg Gale at [e-mail].

[GuHu1]

Antwort auf Beitrag Nr.: 40.541.799 von Magnetfeldfredy am 17.11.10 21:26:49

http://www.bloomberg.com/news/2010-11-17/dendreon-wins-medic…

Dendreon Corp. won the backing of an advisory panel helping the U.S. government decide whether to pay for its $93,000 prostate cancer treatment.

Outside advisers to the Medicare health plan said today they were confident that Dendreon’s Provenge “clinically significantly” improves survival in men with advanced prostate cancer. Medicare, the U.S. insurance program for the elderly and disabled, will take the recommendations into account in a coverage proposal due by March 30 and a final decision in June.

Seattle-based Dendreon won Provenge approval in April based on a study showing a four-month survival benefit. Three-quarters of patients approved for the drug also qualify for Medicare, making next year’s reimbursement decision critical for sales. Provenge may bring in $1.75 billion in 2014 with Medicare coverage, according to the average estimate of four analysts surveyed by Bloomberg.

“It improves survival without the additional adverse reactions that are known with some of the other cancer therapies,” panel member Karl Matuszewski, a pharmacology expert and editor for Reed Elsevier NV health publications, said today at the meeting in Baltimore. “This is really another option.”

Dendreon shares are up 36 percent this year even after having fallen 28 percent since Provenge’s approval on April 29 because of reimbursement and supply concerns. Trading on the stock was halted today on the Nasdaq Stock Market.

To contact the reporter on this story: Catherine Larkin in Baltimore at [e-mail].

To contact the editor responsible for this story: Reg Gale at [e-mail].

[GuHu1]

http://www.washingtonpost.com/wp-dyn/content/article/2010/11…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.541.900 von GuHu1 am 17.11.10 21:39:31

Jetzt bräuchten wir nur noch so einen "Zulassungshüpfer" wie am 29.4.2010!

[GuHu1]

Antwort auf Beitrag Nr.: 40.541.996 von Magnetfeldfredy am 17.11.10 21:51:20

ach was, ein kleiner hopp und dann langsam und stetig reicht, denk an die letzte news zu nj.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.542.042 von GuHu1 am 17.11.10 21:56:17

Hast wohl Recht gehabt mit dem kleinen Hüpfer, aber die Aussichten sind jetzt rosiger denn je und ich werde wieder auf die 1000 Stück aufstocken!

'The Fly': Leerink - OUTPERFORM

News Breaks
07:07 EDT DNDN theflyonthewall.com: Dendreon panel favorable for Provenge reimbursement, says Leerink
Leerink views yesterday's MEDCAC panel as supportive of Dendreon's Provenge's use in the currently approved FDA labeled patients. The firm continues to expect reimbursement of Provenge for the current FDA approved use and maintains an Outperform rating on the stock with a $55 price target. :theflyonthewall

[crivit]

Antwort auf Beitrag Nr.: 40.549.938 von Magnetfeldfredy am 18.11.10 21:33:36

Na dann willkommen back!
Bin immer noch dabei.
Wird noch ein 100$ stock.
;-)
IMO
GLTA

[GuHu1]

Antwort auf Beitrag Nr.: 40.549.938 von Magnetfeldfredy am 18.11.10 21:33:36

freut mich das du vorhast wieder an board zu kommen.
bin mal gespannt wann die fda die erweiterung von nj freigibt, waren es max 4 monate.
soweit ich das verstanden habe ist der median os möglicherweise eher größer als 4,1 monate.
liegt am wechsel des placeboarms zu frovenge (frozen). die daten dazu sollen zum nächsten asco im detail präsentiert werden und dr.frohlich hat das gestern zum ersten mal öffentlich in aussicht gestellt.

bitte korregiert mich wenn da was verdreht habe.

@civit viele sind ja nicht mehr dabei.....

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=379026&pt=…

Provenge survival advantage ... what is it, and why is it worth $93,000?

Whenever I hear or read Provenge described as affording "an average survival benefit of 4.1 months, is that worth $93,000" my impulse is to want to reply to the author with precision and in understandable terms why the premise of the question, that Provenge affords a 4.1 month average survival advantage, is just plain (and materially) wrong. Even those authors who use the term "median," without more, aren't communicating the whole story because most people think "average" when they hear that term.

Also, the question's premise ignores the pathway that drug development typically follows, wherein science builds one step at a time, sometimes in little steps, sometimes one indication at a time, but continues to build in the discovery of new drugs.

This point is critical to the nation's accurate understanding as we progress through the debate over health care costs, not just for Provenge, but for all drugs. Unfortunately, the debate is framed in large part by what people read in the media. If read enough times, it becomes "truth," accurate or not.

So, I am trying to assemble a list of things to say/explain/send, the key points of which a journalist might use in his/her next article. I could use some help with the specifics (which I don't necessarily believe authors would use, but which I think might give them confidence to state the conclusion). Anyone wishing to change/refine/add to my list is welcome to do so. (If this has already been done elsewhere (IR?), just a point in that direction is all I need.)

1. "Average survival benefit" was not calculated (only median, which is very different, was). This is because when data collection from the various studies ended, some patients (an unequal number from both arms) were still living. Necessarily, therefore, it was impossible to calculate the "average" survival benefit for treatment arm (Provenge) patients. In this regard, does anyone know whether followup is being performed of the IMPACT trial participants who were living at the end of the study? Do we know whether a greater number of treatment arm patients were living at the time data collection ended (separate from the three year data, which show a Provenge survival advantage)? If we do, can it be said that it's therefore likely that "average" survival benefit is greater than 4.1 months, we just don't yet know by how much? I don't recall having read this, but if it were true access to a description of the supporting data would be helpful.

2. The "average" survival benefit that Provenge affords is likely (or can we say "known"?) to be higher for the following reason. We know that the three year survival of IMPACT Provenge patients was 40% better (32.1% vs. 23.0%) compared to controls. http://investor.dendreon.com/phoenix.zhtml?c=120739&p=irol-n… This, combined with an understanding of Provenge's MOA, confirms that some patients' immune systems are bolstered sufficiently by Provenge as to enable them to live longer than the "median" Provenge survivor and, more importantly, much longer than the comparable control arm survivor. This "tail" effect on Provenge survivors means that after all patients in the study have died, the "average" survival benefit will have been greater than was the 4.1 month "median" benefit. Is this correct?

3. The survival benefit for Provenge patients is likely to be greater than for true placebo also because the control arm in IMPACT was not a true "placebo" population. I don't recall about the earlier studies, but believe I correctly understand that in IMPACT, at least, control arm patients, or some of them, were given the option to take Frovenge at some point (progression?). So, the control arm was not merely "placebo" in the sense that they received nothing. Provenge, therefore, was being tested against a variation of itself (Frovenge), to some extent. Yesterday there was a suggestion that some of this may be being quantified and that Frovenge is believed to afford a survival advantage, as well. Details?

4. Compared to what? Asking the question "is $93,000 worth 4.1 additional months" erroneously implies that the alternative is to die 4.1 months earlier and save $93,000. But that is not the usual alternative, to my understanding. It seems that the "alternative," at the moment, and which is FDA approved (and, I assume, reimbursed by CMS) would be chemotherapy (taxotere). If that is so, one must calculate the cost of that treatment along with the average cost of treating complications of taxotere therapy in order to answer the question. One also needs to know the survival benefit taxotere affords. In fact, the answer might even be that taking Provenge instead of taxotere actually saves money (in addition to extending life more than does taxotere and doing so with better quality). Mention of this was apparently made yesterday. Has anything been published about this?

5. The ultimate benefit to society can't be measured just by looking at the survival benefit, whatever it is, and improved QOL, in late stage PC patients. As is often the case, Provenge was first tested on the sickest segment of the target disease population. Because of its mechanism of action (immune system stimulation), doctors believe there is good reason to believe it will work better (i.e., afford a greater survival benefit) to patients whose disease has not advanced to the late stage that was the IMPACT population, i.e., patients whose immune systems are not as debilitated and thus more able to respond to stimulation, and whose tumor burden (that the immune system has to fight) is not as large. To be able to test Provenge for a survival benefit in earlier stage PC (the course of which lasts many years), it was necessary first to get it approved in late stage of the disease. Thus, the benefit to society from this drug is likely to be not just to extend the lives of late stage PC patients, but eventually to afford a therapy for earlier stage patients that both increases survival and may, for some, require less severe (and costly) treatment (no surgery, no chemo).

6. The ultimate benefit to society also cannot be measured just by examining the benefit to PC cancer patients. Dendreon has developed a technology platform (details?), and Provenge is only the first medicine to emerge. Research, funded by revenues from Provenge sales, hopefully will result in additional, similar, drugs that will treat other forms of cancer. A good analogy to the past drug development pathway for drugs now taken for granted, and a few key facts about same (e.g., how many years, how the drug was a paradigm shift, what it resulted in) might help. Penicillin?

Thanks in advance to any who can assist in this effort by providing any information or resources.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.549.984 von crivit am 18.11.10 21:38:17

Danke, ich war nie ganz weg, jetzt wieder gut positioniert!
100 Dollar wäre natürlich ein Traum, aber die Hälfte wirds schon werden!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.550.434 von GuHu1 am 18.11.10 22:23:46

Bin schon wieder mit dabei, kann Dich ja nicht allein lassen!

[NoSelters]

Antwort auf Beitrag Nr.: 40.550.434 von GuHu1 am 18.11.10 22:23:46

@civit viele sind ja nicht mehr dabei.....

Hi Guhu und Ihr anderen Recken.

Solltest Du mich gemeint haben...Fehlanzeige!!!

Hatte zwar bei 55.- und 57.- bisschen was verkauft(leider nur ca.20%), aber die übrigen Shares bleiben unangetastet...wenns sein muss noch mehrere Jahre. (die Steuerfreiheit wird mich von vorzeitigen Verkäufen abhalten)

Soll ja bis zur Rente reichen...

Weiterhin alles Gute!

Looong and Strooong....

[GuHu1]

von hakur, ich darf doch oder.

http://img3.fotos-hochladen.net/uploads/chartweeklynx7y0qwa9…

http://img3.fotos-hochladen.net/uploads/chartweekly3k0j18pxy…

[edelupolino]

Antwort auf Beitrag Nr.: 40.550.434 von GuHu1 am 18.11.10 22:23:46

Hi an alle longs,
habe gestern auch im IV-board gelesen, dass die 4,1 monate wohl übertroffen werden:
warten wir mal genaueres ab. Einige dort meinen, dass sich die GRO?EN dieser welt langsam mit den abgegebenen dndn shares vollsaugen; na ja, meine kriegen sie nicht!
Weiterhin viel glück an alle
Ede

[Dividend]

George Soros Current Investment Portfolio 2010
George Soros is the founder of Soros Fund Management. In 1970 he co-founded the Quantum Fund with Jim Rogers and Christoper Ink, which created the bulk of the Soros fortune. Legendary was his currency speculation against the British Bank of England:

On September 16, 1992, Soros's fund sold short more than USD 10 billion worth of pounds sterling, profiting from the Bank of England's reluctance to either raise its interest rates to levels comparable to those of other European Exchange Rate Mechanism countries or to float its currency. Finally, the Bank of England withdrew the currency from the European Exchange Rate Mechanism, devaluing the pound sterling. Soros earned an estimated worth of USD 1.1 billion in the process. He was dubbed "the man who broke the Bank of England." UK Treasury estimated the total costs of Black Wednesday at GBP 3.4 billion in 1997.

Here is a top 30 list of his investment positions as of September 30, 2010 according to the most recent form 13F-HR filed with the SEC on November 15, 2010.

Soros Fund Management LLC was valued at USD 4.77 billion.


During the quarter George Soros had 177 total positions. The sector allocation was as follows:

Oil & Gas: 10.7%
Health Care: 10.6%
Technology: 8.5%
Basic Materials: 7.1%
Consumer Services: 4.7%
Financials: 2.8%
Industrials: 2.7%
Consumer Goods: 1.4%
Utilities: 0.2%

These are the details of George Soros's top stock initiations, closings, buys, and sells:

Top positions closed out by George Soros: ZRAN, ZQK, WOR, WGOV, TSYS
Top positions initiated by George Soros: DNDN, IAU, CTL, DOW, CSGS
Top positions decreased by George Soros: CVS, MEE, NEM, SU, CBT
Top positions increased by George Soros: TEVA, VZ


Related stock ticker symbols:
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http://long-term-investments.blogspot.com/2010/11/george-sor…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.580.188 von Dividend am 24.11.10 10:40:58

Shares of Dendreon (DNDN) dropped to under thirty seven dollars on Monday morning, closing the day ten percent to the downside at $36.70. A dip in the DNDN share price had been expected by some during the time between the FDA's announcement of Provenge approval and the commercial launch of the product, but Monday's drop may also have been the result of an 'honest mistake' by CNBC who had reported that the supply of Provenge outweighed the current demand. CNBC corrected their mistake later in the day, stating that, in actuality, the demand for Provenge outweighed the supply. By then, however, the damage had been done and the DNDN stock embarked on a 10% downward spiral for the day.

Speculation was rampant around the Internet and in the blogosphere that CNBC's 'mistake' was not quite an honest one, but one intended to help out some Wall Street buddies looking to build on their positions for lower prices. CNBC's already suspect track record of honest reporting - including Jim Cramer's questionable tactics - only add fuel to the fire.

That said, whether intentional or not, the damage is done and both existing and prospective longs of the stock should look beyond the alleged manipulation and take advantage of DNDN's dip in price at these levels, and especially if it drops lower.

For all of the controversial history behind Provenge's path to FDA approval, the product is real and the demand is there - as indicated in black and white in CNBC's later article. To be fair to CNBC, the context of the original article did indicate that the original supply vs. demand comment was a misprint. Dendreon is no longer a speculative company or stock - the company has an approved, groundbreaking product nearly ready for commercial launch that could pull in as much as $120 million during the second half of 2010 alone, according to previous company estimates. By 2011, Provenge could be a billion dollar a year product, and that number will - most likely - only grow as production ramps up in Dendreon's production plant in Georgia.

The future is promising for this company, and over the mid to long term, DNDN could very likely become a pure powerhouse in the market, although those that stuck with the company and rode the wave from three bucks already consider the stock a powerhouse winner. However, the short term could be tricky and it wouldn't surprise me to see the stock drop a little further, unwarranted or not.

The sales revenue from Provenge is not yet rolling in and that gives the big players a little bit more time to load up on their positions, which could mean that the big boys are going to keep this one in their buy zone for a while longer. If that turns out to be the case, then this will be a great opportunity for everyone with a mid to long term outlook to load up, in my opinion.

As always, I say buy a little at a time - this way you're in if a run materializes, but there's still money on the sideline to average down if the stock slides any more.

Monday's move undoubtedly created fear and panic for many investors, but look beyond the emotion and concentrate on DD - are the chances good that Provenge will become a bigger winner in the market? VFC says, you bet.

If for some reason this stock drops to below thirty bucks again, I love it. Either way, I think we'll be looking at significantly higher prices in a couple of years from now.

All just my opinion.

Disclosure: No position.
About the author: VFC's Stock House

[GuHu1]

[GuHu1]

Antwort auf Beitrag Nr.: 40.585.734 von GuHu1 am 24.11.10 21:01:32

soryy hab vergessen auf die quelle hinzuweisen, der chart ist von hakur.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.585.745 von GuHu1 am 24.11.10 21:03:36

Dendreon Provenge wird erstattet

Kulmbach (aktiencheck.de AG) - Die Experten vom Anlegermagazin "Der Aktionär" empfehlen, die Dendreon-Aktie (ISIN US24823Q1076/ WKN 615606) bei Schwäche zu kaufen.

Wie erwartet habe sich die amerikanische Krankenkasse Medicare für eine Kostenerstattung von Provenge ausgesprochen. Provenge sei eine von Dendreon entwickelte Anwendung zur Therapie von fortgeschrittenem Prostatakrebs. Auch wenn die endgültige Entscheidung erst im Sommer gefällt werde, seien die Experten diesbezüglich zuversichtlich.


Die Experten von "Der Aktionär" raten, die Dendreon-Aktie bei Schwäche zu kaufen. Das Kursziel sehe man bei 35 Euro und ein Stopp sollte bei 20 Euro platziert werden. (Ausgabe 48) (25.11.2010/ac/a/a)


Offenlegung von möglichen Interessenskonflikten: Mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen

[GuHu1]

http://www.popsci.com/bown/2010/category/health

[edelupolino]

Antwort auf Beitrag Nr.: 40.612.482 von GuHu1 am 29.11.10 23:54:48

Hi GuHu,
das sind ja immer wieder tolle technische fortschritte der menschheit, die da gezeigt werden (Mit der MORAL hapert's bei uns menschen aber überall gewaltig, wie wir wissen). Dendreons leistung ist wahrscheinlich aber höher zu bewerten als die "neuen finger" etc!

Hab vor ca 3 tagen nen brief meiner bank bekommen (seltsamerweise NICHT von CConsors!?), die sagte ich könne mich einer CLASS ACTION (ohne blechen zu müssen) gegen Dndn anschließen. Hab keine ahnung, worum es da geht, hab aber keine lust, bei einer klage gegen dndn dabei zu sein; würd mich aber bestimmt einer C Action gegen Pazdur, FDA etc anschließen, wenn das möglich wär!!!
Ciao an alle longs
Ede

[gutdrauf9]

Hallo edelupolino,
ist das noch die alte Geschichte, bei der es um die Käufe zwischen dem 29. März und dem 8. mai 2007 geht?

[edelupolino]

Antwort auf Beitrag Nr.: 40.615.159 von gutdrauf9 am 30.11.10 13:39:30

Hi gutdrauf9,
ja, das ist so;wer mitmachen will, soll seine unterlagen an einen Claims Admin (Gilardi Co LLC) schicken.
Ciao Ede

[GuHu1]

Antwort auf Beitrag Nr.: 40.614.604 von edelupolino am 30.11.10 12:16:11

hi ede,
ich denke dahinter steckt der user "rancherho" aus dem IV.
bin nicht sicher, aber ich denke er klagt wegen insider handel, mitch`s verkauf vor der der fda entscheidungim (crl)im mai 2007.

[edelupolino]

Antwort auf Beitrag Nr.: 40.619.234 von GuHu1 am 30.11.10 21:31:54

Hi GuHu,
das kann gut sein; ich erinnere mich, dass zu der zeit von Mitchs verkauf viele sehr erstaunt und einige erbost waren.
Ciao Ede

[hakur]

Hi alle,
kann seit Monaten bei WO keinen Chart mehr einstellen.
Muß an den Einstellungen meines PC`s liegen da es bis zu dem Tag an dem ich das System neu aufgespielt habe ohne Probleme ging.
Auf dem IV Board oh Wunder funktionierts auch nach der Aufspielung. Bin etwas ratlos. Für jeden Tipp dankbar

[NoSelters]

Antwort auf Beitrag Nr.: 40.619.961 von hakur am 30.11.10 23:35:55

Hallo Hakur,

wo es bei Deiner "Kiste" hakt weiss ich leider nicht,aber ich stell mal Deinen aktuellen Chart vom IV hier rein.




"Steady as she goes, ... / chart uptade

Had not expected that the PPS bounced back again from the upper side of the triangle ( green line) since last posting.


Ok it did, doesn`t matter to all ultra longs.

Important is that the green triangle includes big potential to the upside, if we assume a "symmetrical triangle"

PPS is at the moment just sitting on the blue big support line, PPS should bounce to north through the upper leg from here. Perhaps need some trading days.





fingers crossed.


glt ALL "


Gruss und weiterhin "Good Luck"

[GuHu1]

Antwort auf Beitrag Nr.: 40.619.961 von hakur am 30.11.10 23:35:55

hakur, was haste denn für ein "neues" system auf deinem pc?

[ditzeroni]

Einigermaßen gute Beschreibung, wie Provenge hergestellt wird:

"Der Impfstoff ist kein präventiver Impfstoff wie die Vakzine gegen Hepatitis B oder humane Papillomaviren, sondern stellt eine autologe zelluläre Immuntherapie dar, bei der die körpereigene Immunabwehr gegen die Krebszellen gestärkt werden soll. Sipuleucel-T besteht aus 50 Mio autologen CD54 Zellen aktiviert mit PAP-GM-CSF suspendiert in 250 ml Lactat Ringer Lösung. Das Antigen wird aus dem Blut des Patienten rekombinant hergestellt. Die rekombinante prostataspezifische saure Phosphatase (PAP) dockt an eine ruhende antigenpräsentierende Zelle (APC) an, die antigenpräsentierende Zelle nimmt das Antigen auf, dieses wird prozessiert und auf der Oberfläche präsentiert. Die voll aktivierte antigenpräsentierende Zelle ist „Sipuleucel-T”. Nach der Infusion aktiviert Sipuleucel-T die T-Zellen im Körper, welche proliferieren und die Krebszellen attackieren. Gesunde Zellen werden dabei kaum angegriffen, da PAP von 95 % der Prostatakrebszellen, nicht aber von den gesunden Zellen der Prostata exprimiert wird.

Um mögliche akute Infusionsreaktionen wie Übelkeit, Schüttelfrost und/oder Fieber zu vermeiden wird eine Prämedikation mit Acetaminophen und einem Antihistamin wie Diphenhydramin ungefähr 30 Minuten vor der Verabreichung empfohlen."
----

Soweit noch ok, aber was dann folgt ist totaler Blödsinn:

"Die Vorteile für den Patienten mit einer Überlebenszeit von 3 Monaten im Vergleich zu 2 Monaten in der Placebo-Gruppe fallen eher bescheiden aus. Die Ergebnisse sind etwa mit einer Chemotherapie mit Docetaxel vergleichbar. Die Verträglichkeit scheint gut zu sein, die Behandlungskosten sind jedoch hoch und die Produktionskapazität ist fraglich."
-----

Ich hab mal ne Zeit lang solche Lügen (absichtlicht oder nicht) überall berichtigt, wo ich sie gesehen habe. Und das waren echt nicht wenige, weil so viele Autoren totalen Blödsinn über DNDN geschrieben haben, aber mittlerweile ist mir die Zeit dafür zu schade.
Wer sowas alles glaubt ohne es zu hinterfragen und sich selber schlau zu machen, ist am Ende auch selber schuld.
Wer nichts weiß, der muss halt das glauben was ihm andere sagen.

Hier der Link noch:
http://focus-blog.pharmxplorer.at/2010/12/sipuleucel-t-prove…

[GuHu1]

http://www.thestreet.com/_yahoo/story/10947745/1/best-biotec…

Best Biotech CEO of 2010 Is...
TheStreet's biotech readers have spoken and Gold, who led Dendreon through a topsy-turvy FDA approval process for the prostate cancer therapy Provenge, garnered a commanding 52% of the votes in the Best Biotech CEO of the Year poll.

[GuHu1]

Chart ist von Hakur, ich darf doch...

[hakur]

Antwort auf Beitrag Nr.: 40.724.102 von GuHu1 am 16.12.10 19:44:53

kein Problem Guhu!
Wenn man das grüne Dreieck als ein symetrisches identifiziert wirds im positiven Sinne sehr interssant
Mal sehen ob der Kurs sich nach dem heutigen Handelstag nach Norden bewegt, sollte er wenn er sich an die Regeln hält;-)
Viel Glück, immer noch loooong seit 2006

Übrigens geht das Bilder hochladen aus unerfindlichen Gründen wieder.

[GuHu1]

http://www.reuters.com/article/idUSTRE6AG5WN20101117


U.S. panel backs Dendreon's Provenge for Medicare

WASHINGTON | Wed Nov 17, 2010 6:05pm EST

WASHINGTON (Reuters) - A U.S. advisory panel backed Dendreon Corp's Provenge prostate cancer therapy on Wednesday, telling the Medicare insurance program for the elderly that available data showed it could help patients.

Shares in the biotech company rose nearly 6 percent after hours. A majority of the outside advisers said there was enough evidence to show that Dendreon's therapeutic vaccine helped patients live longer. The agency is weighing whether to pay for the product nationwide.

"We have some pretty good evidence here," said the panel's chairman, Lewin Group Senior Vice President Clifford Goodman. But he said the evidence is "not really wide, it's not really deep, so much work is needed to collect" more data.

Centers for Medicare and Medicaid Services (CMS) officials will take the panel's advice into account in making a final ruling, expected next year.

Their decision is not only critical for patients but also for Provenge sales, which could reach $1.9 billion by 2014, according to data from Thomson Reuters.

J.P. Morgan analyst Cory Kasimov said the panel's assessment "was a clear positive" for Dendreon.

"It's increasingly clear that CMS will cover Provenge" for approved uses, Kasimov wrote in a research note. "Investors should take a significant amount of comfort."

Medicare coverage could also encourage more private insurers to follow suit.

Aetna Inc, Humana Inc and several other health insurers have already agreed to pay for the vaccine, which does not prevent cancer but fights the tumors.

Patients, doctors and the company urged Medicare's advisers to support their pleas to have the federal government pay for the treatment regardless of its hefty price tag.

"This is a new agent that is clearly beneficial for patients," said Dr. Mark Scholz, a California-based prostate oncologist and one of nearly two dozen public speakers urging the Medicare panel's support.

Provenge was approved for the U.S. market in April to treat men with advanced prostate cancer after company data showed it help men live another 4.1 months on average.

It costs $93,000 for three infusions given over the course of about one month. While many cancer therapies are also expensive, their costs are spread out over more time or are stopped when they do not seem to be helping.

Dendreon says the high price reflects a unique manufacturing process that takes cells from a patient's tumor, mixes them with some of the patient's own immune cells and then infuses the cells back into the patient to attack malignant cells. Most side-effects are related to infusion of the drug.

At the meeting, Medicare's advisers said they were fairly confident in Provenge's effect on survival, but were less sure over whether it helped patients avoid side effects and other treatment issues. They told CMS they had less confidence in wider uses not approved by the Food and Drug Administration.

They also urged Medicare to collect more data as part of its payment decision to learn more about the therapy's use.

In a statement after the meeting, Dendreon said patients can still get Provenge from regional Medicare contractors until CMS makes its national decision.

DRUG COST RAISES FINANCIAL CONCERN

Dendreon Chief Medical Officer Mark Frohlich told the panel that Provenge, also known as sipuleucel-T, is one of few available options that actually helps patients live longer with fewer side effects, providing "an important new treatment."

While the FDA approved Provenge as safe and effective, CMS is deciding whether its use is "reasonable and appropriate." By law, it cannot consider the vaccine's cost in that decision.

Still, there are larger financial concerns for Medicare, and patients have worried that the therapy's price was an unspoken stumbling block, especially since most men with prostate cancer are older and likely covered by the program.

Medicare covers roughly 45 million older or disabled Americans -- 40 percent of whom are men -- but faces financial instability that has drawn the attention of a U.S. deficit panel as well as lawmakers.

"One has to wonder if today's meeting is indeed about something other than the science, namely the cost," said Brad Loncar of Kansas, whose grandfather had the disease.

It was not immediately clear how much of a co-pay Medicare patients would face even if CMS covers Provenge.

Nearly 218,000 U.S. men will be diagnosed with prostate cancer this year, according to the National Cancer Institute, although not all those men will either qualify for Provenge or be enrolled in Medicare.

Other treatment options include chemotherapy, surgery and hormonal therapies, and some patients may need such options even after using Provenge, some doctors told the panel.

CMS has said it is only looking at the data in weighing Provenge. Goodman, the panel chairman, noted the agency in the past has declined to pay for FDA-cleared drugs and devices but has also covered other, experimental ones not yet approved.

Dendreon shares have fallen nearly 38 percent in the wake of FDA's Provenge approval, in part over concerns about its launch. Its shares were halted until late on Wednesday.

(Reporting by Susan Heavey. Editing by Gerald E. McCormick and Robert MacMillan)

[GuHu1]

Antwort auf Beitrag Nr.: 40.727.982 von hakur am 17.12.10 13:13:46

hi hakur,
ich will ja wenigsten fragen bzw. auf den urheber hinweisen.

[GuHu1]

http://advancedprostatecancer.net/?p=2211#more-2211

[GuHu1]

von Hakur:

[NoSelters]

Hmmmm....wird wohl dauern..

http://www.bioportfolio.com/news/article/354622/Lifecell-Aim…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.758.254 von NoSelters am 23.12.10 19:10:32

Frohe Weihnachten an alle Dendronen!

[GuHu1]

Antwort auf Beitrag Nr.: 40.760.663 von Magnetfeldfredy am 24.12.10 15:41:54

yep fredy wünsch ich dir auch.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.760.743 von GuHu1 am 24.12.10 16:45:08

Danke, "alter" Weggefährte!

[Plaste]

Hallo Gemeinde,
ich habe hier mal eine Frage an die longs.
Ich stocke seit Jahren meine Positionen bei Cel-Sci auf, die auch ein sehr interessantes Krebsmedikament namens Multikine entwickeln. Diese Woche wurde der Beginn der PIII gemeldet. Sprich, es wurden weltweit die Einschreibungen von ca 880 Probanten begonnen.
Auf Grund meiner Erfahrung aus den letzten Jahren war ich es gewohnt, das bei der Meldung vom Beginn der PIII, egal bei welcher Biotechaktie, erheblichen Kurssteigerungen drin sind.
Bei CelSci war dem nicht so. Wobei mich das persönlich nicht unbedingt beunruhigt, da ich davon ausgehe, dass bei Zulassung von Multikine einiges auf die Aktionäre zukommt.
Wie war es bei Dendreon, wie hat sich der Entwicklungsstand von Provenge im Kurs der Aktie bemerkbar gemacht?
Hat DNDN mit der Meldung PIII oder erst mit der Meldung vom Beginn der Impfungen reagiert?
Hattet Ihr das Gefühl, das der Kurs erheblich manipuliert wird, wie mir es gerade bei Cel-Sci vorkommt.
Auch wenn CVM nicht gleich DNDN ist und auch der Kurs vermutlich anders reagieren wird, bin ich auf Eure Antwort gespannt.
Wäre nett, wenn sich einer von Euch noch an diese Zeiten erinnern könnte.

Danke
und allen einen guten Rutsch,
Plaste

[ditzeroni]

Unerwartete Hilfe:
http://www.judicialwatch.org/news/2011/jan/jw-sues-health-an…

Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced today that it filed a lawsuit on January 3, 2011, against the Obama Department of Health and Human Services (HHS) regarding a controversial decision by the Centers for Medicare and Medicaid Services (CMS) to undertake a one-year review of the prostate cancer treatment Provenge to determine if the treatment is “reasonable and necessary” and should therefore be reimbursed.
.
.
“The Obama administration claims there is no merit to the charge that the Provenge decision is the first step in implementing healthcare rationing so why not release these records? What does the Obama administration have to hide? Provenge is an FDA approved drug that has a proven track record and the Obama administration has no legal right to deny this treatment based on its cost. But the American people are right to be concerned about this Provenge review, given the fact that a man dubbed ‘Death Panel Donald’ Berwick is in charge of Medicare and Medicaid,” stated Judicial Watch President Tom Fitton.

Ist ja mal unerwartet..gibt es doch tatsächlich noch Leute mit Rückgrat und Eiern!
Hauptsache da kommt diesmal auch was bei rum und die korrupten Penner landen da, wo sie hingehören!!

Freitag gibts übr einen neuen positiven Report über DNDN, erklärt mM nach den Kursverfall bis dahin.

[ditzeroni]

Morgen, 15 Uhr, gehts ab.
Dazu noch der positive Bericht von Deutsche Bank morgen früh, nicht vergessen!

Dendreon to Host Conference Call to Provide Updates on U.S. Commercialization Progress, European Strategy for PROVENGE, and Pipeline Progress
Conference Call to be Hosted Friday, January 7, 2011 at 9:00 a.m. ET

SEATTLE, Jan. 6, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN) management will host a conference call on Friday, January 7, 2011 at 9:00 a.m. ET to provide updates on U.S. commercialization progress, European strategy for PROVENGE, and pipeline progress.

Date:


Friday, January 7, 2011


Time:


9:00 a.m. ET / 6:00 a.m. PT


Dial-in:


1-877-548-9590 (domestic) or [phone] (international);




conference pass code 35063654


Webcast:


www.dendreon.com (homepage and investor relations section)

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.815.380 von ditzeroni am 06.01.11 22:17:34

Bin wieder mit 1000 Stück dabei und hoffe auf good news!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.817.064 von Magnetfeldfredy am 07.01.11 10:09:11

News sind raus:

Dendreon Announces Plans to Seek Marketing Authorization for PROVENGE in Europe
- Company to Provide Updates on U.S. Commercialization Progress, European Strategy for PROVENGE, and IND Filing for DN24-02 -
Conference Call to be Hosted Friday, January 7, 2011 at 9:00 a.m. ET


ShareretweetEmailPrintCompaniesendreon Corporation Related Quotes
Symbol Price Change
DNDN 35.42 0.00


{"s" : "dndn","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Dendreon Corporation On Friday January 7, 2011, 8:30 am
SEATTLE, Jan. 7, 2011 /PRNewswire/ -- Dendreon Corporation (NasdaqNDN - News) today announced several updates regarding the U.S. commercialization of PROVENGE® (sipuleucel-T), the European strategy for PROVENGE, and progress on its pipeline. The Company will host a conference call at 9:00 a.m. ET to review additional details.

"Last year was foundational for Dendreon with the successful introduction of PROVENGE as the world's first autologous cellular immunotherapy," said Mitchell H. Gold, MD, president and chief executive officer. "As we look to 2011 and beyond, we are positioned for significant growth with our increased capacity in the U.S., our European strategy for filing now set, and our progress in advancing our ACI pipeline in bladder cancer. Most importantly, we are proud to deliver on our commitment to transform the lives of patients with cancer by making PROVENGE more broadly available in the U.S. and abroad."

U.S. Commercialization


In 2010, Dendreon achieved revenues from PROVENGE of approximately $48 million.
In anticipation of a ten-fold increase in capacity from its facilities in New Jersey, Los Angeles, and Atlanta coming on line this year, Dendreon has increased its sales force to approximately 100 reps to service approximately 450 centers by the end of 2011.
In 2011, Dendreon plans to increase marketing and awareness efforts to educate physicians and patients and to maximize the additional capacity.




European Plans


Following a number of pre-submission meetings with European Union (E.U.) National Agencies, the company expects that data from the IMPACT study, supported by data from D9901 and D9902A, will be sufficient to seek regulatory approval in the E.U.
Dendreon plans to use the clinical data described in its U.S. Biologics License to file its marketing authorization application (MAA) to the European Medicines Agency (EMA) in late 2011/early 2012.
To accelerate the regulatory timeline, initially PROVENGE will be manufactured through a Contract Manufacturing Organization (CMO) while Dendreon concurrently builds an immunotherapy manufacturing facility in Europe.
The company anticipates a regulatory decision in the first half of 2013.




DN24-02 IND Filing


Dendreon filed an Investigational New Drug (IND) application in December 2010 with the U.S. Food and Drug Administration (FDA) for DN24-02 for the treatment of invasive bladder cancer.
The randomized Phase 2 study will evaluate the safety and efficacy of DN24-02 in patients with HER2+ invasive transitional cell carcinoma (TCC) of the bladder following cystectomy.
The primary endpoint is to evaluate overall survival. Approximately 180 patients will be enrolled at clinical sites throughout the U.S.




Conference Call Information

Dendreon will host a conference call today at 6:00 a.m. PT, 9:00 a.m. ET. To access the live call, dial 1-877-548-9590 (domestic) or [phone] (international). The call will also be audio webcast and will be available from the Company's website at www.dendreon.com under the "Investor/Webcasts and Presentations" section. A phone replay of the call will be available for 3 days by calling 1-800-642-1687 (domestic) or [phone] (international); Passcode: 35063654.

PROVENGE Indication and Safety

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The most common adverse events (incidence greater than or equal to 15%) reported in patients in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in patients in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1,500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

For more information on PROVENGE, please see the full Prescribing Information at www.provenge.com or call Dendreon ON Call at 1-877-336-3736

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.

This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon's business and prospects, including progress on the commercialization efforts for PROVENGE. Information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.


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[GuHu1]

Antwort auf Beitrag Nr.: 40.819.881 von Magnetfeldfredy am 07.01.11 14:41:13

yep fredy.

http://www.thestreet.com/_yahoo/story/10966401/1/dendreon-br…

SEATTLE (TheStreet) -- Dendreon(DNDN_) will not be required to conduct new clinical trials of its prostate cancer treatment Provenge in order to seek European approval late this year or early in 2012, the company said Friday.

If all goes as planned, Dendreon expects European regulator to approve Provenge to in the first half of 2013. Provenge is a personalized vaccine unique to each prostate cancer patient. To sell the treatment in Europe, Dendreon plans first to hire a contract manufacturer to make Provenge while the company concurrently builds its own European manufacturing facility to be located in Germany.

Dendreon did not disclose the cost of building that European manufacturing plant, nor how long construction will take. The company did say that it will need to raise additional funds to complete its European expansion.

Provenge sales in 2010 totaled $48 million, the company said, slightly ahead of Wall Street's consensus estimate of $47 million.Dendreon forecast 2011 Provenge sales of $350 million to $400 million, in line with current consensus of $370 million.

Provenge is currently manufactured for U.S. patients at a company-owned facility in New Jersey expected to reach full capacity later this quarter, pending FDA approval. Two additional U.S. Provenge plants are under construction, expected to be completed and operational in the middle of the year.

Dendreon shares were up 2% to $36.17 in recent trading.

--Written by Adam Feuerstein in Boston.

[GuHu1]

Hakur`s chart :


""think earlier or later this open GAP ( between the red lines) from today will get closed. At the arrow you can see a muliple resisist too.""


People at this point have no propleme to say my earlier statement this day seem to be wrong!

PPS did take out the resist with much volume and power ! Take a look at the volume at the bottom of the chart.
If PPS remains significantly over the next few days over that resist near by $ 37,15 I tend to read the gap as a classic Break away Gap.
One we can say the loved falling wedge did his work,
now lets see who will win this game at the end . Won`t be a short here ;-)

best of luck ALL
PS: next step can be 23.60% fibo retracment

[ditzeroni]

Jan 7, 2011 03:07PM

Needham & Company reiterates a 'Buy' on Dendreon (NASDAQ: DNDN), PT $62.

Needham analyst says, "We are encouraged by Dendreon’s thoughtful strategy and execution to date, meeting and in some ways exceeding guidance in terms of sales, expansion in manufacturing, and global expansion. We expect strong PROVENGE sales growth into 2H11, as the Company increases US manufacturing by 10x since initial launch in combination with an increased marketing effort. We believe that Dendreon’s EU plans have a high likelihood for success, given the EU’s focus on overall survival as an outcome and entire cost-of-care (versus simply drug costs) in making reimbursement decisions."

[GuHu1]

http://www.americanconsumernews.com/2011/01/deutsche-bank-ny…

Deutsche Bank (NYSE: DB) Analysts Raise Price Target on Dendreon Co. (NASDAQ: DNDN) Shares to $54.00
January 11th, 2011 • Related • Filed Under • by ACN Staff
Filed Under: Stock Market News

Deutsche Bank (NYSE: DB) research analysts increased their price target for shares of Dendreon Co. (NASDAQ: DNDN) from $44.00 to $54.00 in a research note issued to investors on Friday. They currently have a “buy” rating on the company.

Dendreon Co. (NASDAQ: DNDN)’s stock opened at 38.21 on Tuesday. Dendreon Co. has a 52 week range of $25.78 to $57.67. The stock’s 50-day moving average is $36.73 and its 200-day moving average is $36.9. Analysts predict on average that Dendreon Co. will post $-0.43 earnings per share next quarter. The company has a market cap of $5.515 billion and a P/E (price-to-earnings ratio) of N/A.

[GuHu1]

http://www.fool.com/investing/high-growth/2011/01/14/dendreo…


Dendreon Rakes in $540 Million to Seize Opportunity for Provenge in U.S., Europe

By Luke Timmerman, Xconomy.com | More Articles
January 14, 2011 | Comments (0)

Seattle-based Dendreon (Nasdaq: DNDN) said today it has pulled in $540 million in new capital, through a debt offering that can be converted into stock. Dendreon, the maker of an immune-boosting therapy for prostate cancer, will have to pay back the debt, plus about 2.9% interest, by January 2016, although the debt can be converted into stock at prices of $51.24 a share or higher.

Dendreon expects net proceeds from the deal of about $529 million, which it wants to plow into more clinical trials, a European factory to make its drug, and increasing investment in its U.S. manufacturing plants. The offering -- which ended up bigger than Dendreon anticipated in an announcement yesterday -- is being led by JP Morgan Securities. It comes on the heels of the JP Morgan Healthcare Conference, the big annual biotech investment gathering.

Last Friday, on the eve of the JP Morgan soiree, Dendreon held a conference call to discuss its plans to go it alone in Europe -- retaining 100% of the commercial rights for itself instead of seeking a partner. The company said it had met with European regulators and was confident in its ability to win regulatory approval for sipuleucel-T (Provenge) based on the same essential body of evidence that won over the U.S. Food and Drug Administration. In going it alone, Dendreon said it planned to build its own factory in Germany -- which would certainly take more capital than it raised a year ago, when it was thinking mainly about the U.S.

JP Morgan analyst Cory Kasimov, in a note to clients last Friday, called Dendreon's European strategy a "tasty pre-conference appetizer." He added that the drug has an 85% chance of winning approval for sale in Europe, and could reach $2.25 billion in sales there by its peak year of 2018 -- even more than its $2 billion peak annual sales potential in the U.S. In his view, that means the Provenge European prospects are worth about another $17 a share, and the stock could climb to $66 a share by December, Kasimov said.

Of course, lots of things could go wrong, which weren't highlighted so much in that JP Morgan report. European regulators might ask for more data, and already tricky manufacturing logistics could be further complicated by different languages and cultures across Europe. Dendreon has also said it expects to price the drug comparably to its $93,000 per patient price in the U.S., which could prompt government health authorities to push back hard. Dendreon has faced similar pressure in the U.S., and hasn't backed off one bit, arguing its drug is worth the money because it extends life a median of about four months, with minimal side effects -- a rarity for a cancer drug.

Investors like the bold move Dendreon has made by going it alone and raising a big chunk of its own money. Dendreon stock climbed 1.5% today.

[GuHu1]

Antwort auf Beitrag Nr.: 40.868.067 von GuHu1 am 15.01.11 13:47:42

....Investors like the bold move Dendreon has made by going it alone and raising a big chunk of its own money. Dendreon stock climbed 1.5% today.

auch die investoren in frankfurt bzw. D.....

[Der.Eroberer]

Auf meiner Suche nach einem all-in Investment bin ich diese Woche fündig geworden. DNDN
bietet das Potenzial, dass ich mir von einem aufstrebenden Unternehmen erhoffe. Der CC
zu Q3/2010 hat mich bewogen hier mit einer schönen Stückzahl einzusteigen. Die im Januar
präsentierten Aussichten bringen mich auf folgende Umsatzschätzungen für die nächsten Jahre:

2011: 375 Mio Dollar
2012: 850 Mio Dollar
2013: 1,1 Mrd Dollar
2014: 1,6 Mrd Dollar.

Die faire Bewertung des Unternehmens würde ich auf das 10-fache des Umsatzes des folgenden
Jahres festsetzen (nicht zu aggressiv, andere Unternehmen wie AMGN oder CELG haben in dieser Phase
weitaus höhere Bewertungen erzielt):

Ende 2011: 60 Dollar/Aktie
Ende 2012: 78 Dollar
Ende 2013: 113 Dollar.

Bei dieser Betrachtung lasse ich ganz bewusst die Gewinne aus dem Spiel. DNDN wird in den nächsten
Jahren viele Investitionen tätigen müssen, um das Wachstum bewältigen zu können. Trotzdem
traue ich dem Unternehmen zu, dass es im Q4/2011 erstmals Cash-Flow positiv sein wird.

Eure Einschätzung zu den o.g. Annahmen würde mich brennend interessieren...

[GuHu1]

Antwort auf Beitrag Nr.: 40.907.221 von Der.Eroberer am 22.01.11 12:40:32

hi eroberer,
tja vorrausgesetzt die noch zu bewältigenden hürden werden genommen, wovon ich persönlich ausgehe.

1. fda zulassung des ausbau new jersey`s von 25% auf 100% und den aufbau der werke in orange county, california und atlanta, georgia.
2. erwartete on label kostenübernahme (ich glaub da kommt was im juni??)

ansonsten liegste auf kurs von dendreon bzw.david miller.

http://www.minyanville.com/businessmarkets/articles/dendreon…

....The guidance implies the fourth quarter of 2011 will be $175-200 million. If one assumes no added growth for 2012, which would be very odd, this projects to 2012 sales of $700-800 million. If you project even modest month-to-month sales growth for 2012, you get over $800 million in sales in a hurry. This means 2012 buy side revenue estimates -- which are largely at the whisper-number stage -- need to be revised higher.

It also provides the discerning research consumer with a nice metric. If an analyst has 2011 sales in the $350-400 million range but has 2012 sales estimates below $700 million, you should ask him/her what's expected in 2012 to cause sales to decline for Provenge. If the analyst projects 2012 sales between $700-800 million, ask why his/her model assumes no or very low growth in 2012 compared to 2011. I’ll give you a hint as to what the answer shouldn’t be: It’s not likely to be demand related or connected with competition. ......

auch nett:

http://seekingalpha.com/article/247733-top-20-most-undervalu…

http://www.minyanville.com/businessmarkets/articles/provenge…

[Der.Eroberer]

Ich gehe davon aus, dass die kommenden Meilensteine genommen werden können. Die CMS-
Situation hat sich nach dem November-Termin aufgehellt. Mir gefällt auch, dass die
eigenen Prognosen nicht zu offensiv sind. Das gibt Raum für Prognoseanhebungen. Selbst
wenn diese nicht kommen sollten, ist das Wachstum ausreichend hoch, damit deutlich
höhere Kurse gerechtfertigt wären. Das Management macht einen guten Eindruck und
vermittelt Kompentenz.

Läuft denn NJ derzeit auf 25%? Ich dachte da würden bereits 50% durchlaufen...
Habe hierzu nichts gefunden. Derzeit ist die Oberkannte des Umsatzes bei 9-10 Mio
pro Monat.

[ditzeroni]

Antwort auf Beitrag Nr.: 40.909.074 von Der.Eroberer am 23.01.11 11:43:32

November 10, 2010
Dendreon Submits Post-Approval Supplement to the PROVENGE Biologics License Application for New Jersey Manufacturing Facility

SEATTLE, Nov. 10, 2010 /PRNewswire via COMTEX/ --

Dendreon Corporation (Nasdaq: DNDN) today announced that it has completed the submission of the post-approval supplement to the PROVENGE® (sipuleucel-T) Biologics License Application for the Morris Plains, New Jersey manufacturing facility. Dendreon is requesting licensure for an additional 36 workstations to manufacture PROVENGE. The standard U.S. Food and Drug Administration (FDA) review for a post-approval supplement to a Biologics License Application is typically four months.

"The submission requesting licensure for additional capacity of the New Jersey manufacturing facility is an important milestone as we work to make PROVENGE more widely available to the many patients who may benefit from it," said Mitchell H. Gold, M.D., president and chief executive officer.

Dendreon's manufacturing facility in Morris Plains, New Jersey is currently operating at 25 percent capacity, with 12 workstations available to manufacture PROVENGE. With the FDA approval of the post-approval supplement to the Biologics License Application, the facility will have a total of 48 workstations. PROVENGE is the first in a new therapeutic class known as autologous cellular immunotherapies.

[Der.Eroberer]

Antwort auf Beitrag Nr.: 40.909.154 von ditzeroni am 23.01.11 12:11:06

Danke für die Info! Das bedeutet, dass ab Q2 bis zu 40 Mio Umsatz pro Monat in NJ
durchgeschleust werden könnten. Nimmt man eine Auslastung von 75% an, dann könnte man
mit 30 Mio pro Monat rechnen und damit über 200 Mio im ganzen Jahr alleine aus NJ.
Das lässt doch das Ziel von 350-400 Mio recht konservativ erscheinen.

[ditzeroni]

Antwort auf Beitrag Nr.: 40.909.207 von Der.Eroberer am 23.01.11 12:31:21

Sehr vereinfacht sieht es mM nach so aus:

2011

1Q: NJ 12 Workstations -> 30 Mio $
2Q: NJ 48 WS -> 120 Mio $
3Q: NJ 48 WS -> 120 Mio $
4Q: NJ 48 WS -> 120 Mio $
------------------------------------
= 390 Mio $

Ab Juni/Juli kommen je 36 WS dazu in den beiden anderen Werken:

Aug/Sept 72 WS -> 120 Mio $
4Q: -> 180 Mio $
------------------------------------
300 Mio $

Insgesamt $690 Mio, was natürlich total vereinfacht ist und keine exakte Aussage darstellt. Natürlich muss man noch viele Dinge in die Überlegung einfließen lassen, wie ramp-up, Anzahl der apharesis-center, logistik-probleme (Wetter), usw...
Am Anfang werden die Fabriken auch nicht direkt zu 100% laufen können, aber im Laufe der Zeit wird die Performance stetig besser werden.

DNDN selber sagt einen 2011 Umsatz von 350-400 Mio voraus, mit der Hälfte davon im Q4, also ca 200 Mio.
Sieht schwer nach underpromise and overdeliver aus.


Sollten sie die selbstgeschätzten $400 Mio umsetzen, entspräche das 4300 Patienten.
Bei jährlich ca 27K neuen in Frage kommenden AIPC Patienten wären das nur zu behandelnde 16% der Patienten.
Das klingt für mich nach zusätzlichen Werken in den kommenden Jahren, zB Chicago und irgendwo zentral in USA.
Dazu kommen in Zukunft hoffentlich noch der 4-5x größere Markt der ADPC-Männer, die im Moment alle off-label sind.
Mit neuen Tests ist die Immunantwort vllt bald schneller und einfacher nachweisbar, und Jahr(zehnte)lange Testreihen sind hoffentlich unnötig, um die Vorteile von Provenge darzulegen.

Und der EU-markt ist auch noch ca 1,5-2x so groß wie USA.


Laut DNDN ist der US-markt bei ca 2 Mrd $ für on-label, für EU dann 3-4 Mrd $ (bei gleichem Preis für Provenge), macht ca 5,5 Mrd $, aber natürlich erst in einigen Jahren.
Nehmen wir 5 Mrd, geteilt durch ca 150 Mio Aktien, multipliziert mit für Biotech üblichem Umsatzmultiple von 9, kommt dabei ein Kurs von $300 pro Aktie heraus.

Total vereinfacht, aber veranschaulicht das Potenzial.

Nicht einberechnet der ADPC-Markt, Neuvenge, trpp8 (wenn das überhaupt nochmal was wird!!),..

Wie man sieht ist noch vieles möglich, aber leider auch viel verpasst worden.
Wäre die FDA nicht so ein korrupter Dreckshaufen voll egoistischer asozialer Penner, wäre DNDN schon 3 Jahre in der Entwicklung weiter.
So sind in der Zwischenzeit unzählige tausende Patienten gestorben, weil sie kein Provenge erhalten haben, und es sterben weiter tausende weil die Idioten es nicht geschissen kriegen, die restlichen 75% in NJ zu inspizieren..

Genug aufgeregt.

Falls jemand eine Aktie weiß die für die nächsten Jahre bessere Perspektiven bietet, bitte bescheid sagen.

[Der.Eroberer]

Antwort auf Beitrag Nr.: 40.909.848 von ditzeroni am 23.01.11 16:42:34

Ich glaube nicht, dass die WSs in NJ gleich unter Vollauslastung in Q2 laufen werden.
Außerdem wird man die Auslastung in NJ zu Gunsten der anderen Standorte drosseln.
Aber ich gebe dir Recht, das sieht stark nach Übererfüllung aus. Hätte ich nichts
dagegen. Allerdings werden die Kapazitäten sehr vorsichtig ausgelastet. Man möchte
weder Patienten noch Ärzte enttäuschen. Eine richtige Strategie. Was nutzt es, wenn
man groß die Werbetrommel schlägt und dann den Bedarf nicht decken kann. Ich rate jedem
den Conference Call zu Q3/2010 inkl. Q&A - Runde zu lesen. Das Management macht
einen besonnenen Eindruck.

[GuHu1]

na ich hoffe doch NOCH nicht.... außer es ist ein unanständig hohes angebot.

Dendreon (Nasdaq: DNDN): SAC has been reducing its stake in Dendreon, but still owned a 6.12 million share chunk at the end of the latest quarter. With FDA approval of prostate cancer drug Provenge, Dendreon is ripe for a buyout from a number of big pharmaceutical companies.

http://www.streetinsider.com/Hedge+Funds/This+Hedge+Fund+Gur…" target="_blank" rel="nofollow ugc noopener">http://www.streetinsider.com/Hedge+Funds/This+Hedge+Fund+Gur…

[ditzeroni]

Äußerst lesenswert:
http://www.bioportfolio.com/news/article/427823/Where-Immuno…

[Der.Eroberer]

Doch ein Übernahmeangebot?

http://online.barrons.com/article/SB500014240529702043316045…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.949.731 von Der.Eroberer am 30.01.11 12:07:50

Kannst Du den Inhalt veröffentlichen bzw. sagen was die über Dendreon genau sagen, ich kann nicht öffnen, danke!

[Der.Eroberer]

Barron's hat 13 potenzielle Übernahmekandidaten genannt. Darunter auch Dendreon. Durchschnittliche Übernahmeprämie war in den letzten Jahren 40%. Das wäre mir aber auf aktuellem Niveau deutlich zu wenig.

[GuHu1]

Antwort auf Beitrag Nr.: 40.956.516 von Der.Eroberer am 31.01.11 19:25:28

geb dir recht, wäre mir auch viel zu wenig, besonders unter folgenden aspekten.
zur info david miller beschäftigt sich seit langem mit dndn!

http://www.minyanville.com/businessmarkets/articles/dendreon…

Debate Over Dendreon's Provenge Coverage Is Settled
By David Miller Jan 31, 2011 8:50 am
The prostate cancer treatment has experienced positive changes this month, meaning Wall Street no longer has to wait for the the March draft National Coverage Determination from the CMS.
The cover story in this week’s Barron’s takes the opinion that slack revenue growth and bored salespeople at big pharma will spur acquisitions in the biotech space. Dendreon (DNDN) is one of the 13 companies mentioned as potential targets in the article. I agree, though the company will need to prove some things in 2011 to get the kind of money shareholders want.

Dendreon has guided for $350 million to $400 million in sales for 2011. Less well known, but important, is the additional guidance that half of these sales are expected in the fourth quarter of 2011. By the last quarter of this calendar year, Dendreon will be producing product from all three of its US manufacturing sites. Cost of goods will come down and Dendreon will start being able to meet the significant demand for this product.

The Barron’s article contains the line, “…and the Street wonders whether [Dendreon] can ultimately top $1 billion annually.” If we take the midpoint of Dendreon’s revenue guidance ($375 million) and follow its guidance that at least half of that comes in the fourth quarter ($187.5 million), Provenge sales will reach an annualized run rate of $750 million by the end of 2011.

With that sort of revenue growth trajectory, it isn’t hard to imagine Provenge could hit a billion dollars in 2012.

Reimbursement

Once Provenge was finally approved, the story turned to whether insurers would reimburse its $93,000 sticker price. This story was given a great deal of juice by the Center for Medicare and Medicaid Services (aka CMS) opening a National Coverage Assessment (shortened to NCA) to “determine” whether Provenge would be covered. Many thousands of words were written about this determination by the media.

What hasn’t been written is how three key developments in January materially changed this story.

First, Dendreon announced private insurers have made positive coverage determinations covering 80% of potential patients. Private insurers, unlike CMS, are under no Congressional mandate to cover FDA-approved drugs. The fact enough of them have agreed to cover the drug for on-label use to cover 80% of insured American men is a good sign CMS will too.

Second, it’s a little known fact private companies administer Medicare and Medicaid under contract by the US government. These private insurers make their own coverage determinations according to rules set by Congress. CMS can override these “local” coverage determinations through the NCA process.

At the time of the CMS panel on Provenge in November, 14 of 15 local subcontractors had already decided to cover Provenge. A couple of weeks ago, so did the fifteenth. Their coverage inclusions and exclusions mirror the FDA-approval label and entry criteria for the pivotal trial. The result is the reimbursement of Provenge with no unexpected restrictions.

This makes it highly likely CMS will make a decision for full on-label coverage of Provenge when CMS issues its draft coverage in March. This is particularly true since this fifteenth subcontractor was likely the reason for the NCA being created in the first place.

That brings us to our third key development. The patient advocacy group Care To Live has been very active on the Provenge story on behalf of men with prostate cancer. Shortly after CMS announced the NCA, Care To Live filed a Freedom of Information Act (FOIA) request to find out why.

The “why” of the NCA isn’t an idle question. Some on Wall Street decided maybe it was a problem with Provenge data -- an extension of their failed view that the Provenge data are somehow flawed. The media thought it was because of the “high price” of Provenge. Regulatory insiders suggested the issue was merely confusion about what Provenge was -- drug or a discrete series of already covered procedures.

Care To Live’s FOIA answered this. In the 15 pages of documents, there was never a question of whether the drug worked or its price being too high. There were questions, largely from that fifteenth subcontractor, about whether Provenge was a new drug or simply a collection of existing procedures.

Bottom Line on Reimbursement

All 15 CMS subcontractors are covering Provenge. The whole question of CMS coverage had nothing to do with the data or efficacy of Provenge. It was confusion on the part of some local contractors about whether it was a new drug or compilation of existing procedures. The subcontractor who asked this question the loudest decided their questions were sufficiently answered by last November’s panel and decided in favor of full, on-label coverage for Provenge.

In light of the new information received over the last month, it is pretty safe to say the March draft National Coverage Determination from CMS will be the least eventful event in Dendreon’s history.

It’s hard reading Wall Street’s mind about why a stock is trading where it is. A number of Dendreon analysts called it their best idea in biotech for 2011 with price targets near or above $50 a share. That’s a 43% gain from where Dendreon is trading right now.

If Wall Street is holding back from jumping on the Dendreon bandwagon because of this CMS thing in March, I’m guessing they aren’t aware of the change in this story over the last month. Because the reimbursement story did change and it changed for the better.

[GuHu1]

das hatte ich gar nicht so auf dem schirm, aber klar, a_technical_1 hat recht, provenge ist halt keine pille von der stange.......

Does it Surprise Anyone....?

That the Company has been excruciatingly careful in producing Provenge since its approval by the FDA last April?

The last thing the Company could endure would be some kind of incident involving a preparation error. This is the root cause of the very slow roll-out so far; at least that is what my intuitive nature tells me. Once the FDA is out of the way, while the Company will still remain as careful as it should, this period of "dotting every i, and crossing every t, will be behind us.

As I said last Thursday morning, "load 'em up folks, while they're still cheap." They won't be for long now.

glta DNDN longs,
a tech

http://www.investorvillage.com/smbd.asp?mb=971&mn=386006&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.956.709 von GuHu1 am 31.01.11 19:55:30

Servus GuHu1,

ich bin mit einer Miniposition drin, aber habe auch Bedenken, z.B. beim letzten CC wurde keine Anzahl von Rezepten für Provenge genannt, im Herbst schon?
Bevor CMS keine eindeutige Freigabe erteilt, denke ich, wird nicht viel passieren, wir sind auch nicht mehr ganz billig, 5 Milliarden US Dollar!

Der Knoten muß sich öffnen volle Erstattung für das FDA zugelassene Label, Zulassung von NJ.....

Erst dann können wir meiner Meinung nach wieder zu alten Höhen aufsteigen, oder?

[GuHu1]

Antwort auf Beitrag Nr.: 40.962.940 von Magnetfeldfredy am 01.02.11 17:58:09

da bin ich voll dabei, wann NJ das go oder nicht go bekommt spätestens märz.
wann bzw wie entscheidet CMS ? , folgendes sagt Miller:

All 15 CMS subcontractors are covering Provenge. The whole question of CMS coverage had nothing to do with the data or efficacy of Provenge. It was confusion on the part of some local contractors about whether it was a new drug or compilation of existing procedures. The subcontractor who asked this question the loudest decided their questions were sufficiently answered by last November’s panel and decided in favor of full, on-label coverage for Provenge.

In light of the new information received over the last month, it is pretty safe to say the March draft National Coverage Determination from CMS will be the least eventful event in Dendreon’s history.

link 3 postings über diesem

scheinbar eine frage des richtigen zeitpunktes, natürlich nur wenn man von 2 positiven bescheiden ausgeht. gibts einen negativen, geh ich kotzen (sorry).

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.963.843 von GuHu1 am 01.02.11 19:45:38

Warum bleibt der Kurs unten, die Aussichten stimmen ja?

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=387067&pt=…

JP Morgan reiterates overweight rating
J.P. Morgan is out with its report today on Dendreon (NASDAQ: DNDN), reiterating Overweight after visiting DNDN's newly constructed Provenge facility.

In a note to clients, J.P. Morgan writes, "This was a productive trip that reinforced our high level of conviction in DNDN. Whether investors wait for greater execution comfort in March (NJ facility approval and CMS memo) or a demand sneak peak with 2Q sales results this summer (the first at heightened capacity), we do expect the main bear stories to be addressed in the NT that could allow for significant appreciation of DNDN shares."

J.P. Morgan has a $66 PT on DNDN.
Shares of DNDN closed Friday at $35.51, up 2.42% from Thursday's close.

[NoSelters]

Antwort auf Beitrag Nr.: 40.998.650 von GuHu1 am 07.02.11 23:18:01

Hallo Guhu,

ehrlich gesagt machen mich die vielen positiven Analysten,verbunden mit der hohen Shortquote etwas unruhig. (Erinnerungen werden wach... )
Leider hatte "Big Money" bei DNDN bisher immer recht.
Ich hoffe sehr ich sorge mich umsonst und wir erklimmen bald wieder alte Höhen.

So loooong....


P.S. @ Hakur : Rec.-Funktion beim IV funktioniert bei mir seit längerem nicht mehr. Ich schätze Deine Beiträge nach wie vor sehr!!!

[GuHu1]

Antwort auf Beitrag Nr.: 41.002.094 von NoSelters am 08.02.11 14:35:03

was soll man sagen, die beiden ausstehende punkte nehmen halt einige zum anlass gegen dndn zu wetten. 2011 kann ein dndn jahr werden ist aber nicht zwangsläufig so....

[GuHu1]

http://www.roswellpark.org/media/news/first-fda-approved-can…


......Dr. Pili says RPCI researchers hope to conduct clinical trials that will combine Provenge with other types of treatment, with the goal of improving the effectiveness of the vaccine therapy. “This is just the beginning,” he says. Pamela Germain, MBA, Vice President for Managed Care and Outreach, says RPCI will work closely with healthcare payers to ensure that treatment costs will be preauthorized for eligible patients.........

[GuHu1]

Antwort auf Beitrag Nr.: 41.002.094 von NoSelters am 08.02.11 14:35:03

no, ganz unbegründet sind deine sorgen nicht, das ist erst durch wenn die farbe vom stempel nicht mehr verwischt.

[GuHu1]

http://www.miamiherald.com/2011/02/08/2055167/new-therapy-fi…

[Kopflaus]

Antwort auf Beitrag Nr.: 41.006.308 von GuHu1 am 08.02.11 23:09:24

Hi
Der Mann hatte 45 Bestrahlungen über 13 Jahre verteilt,
dazu noch Medikamententerapie.
Eine Bestrahlung kostet 7.000 bis 10.000 Dollar.
Das wären ca. 400.000 Dollar, das ganze Leid kommt ja noch dazu.
Provenge kostet 93.000 Dollar und wird 3 mal über 2 Wochen eingenommen.
Nebenwirkungen relativ gering.
Warum wird da noch diskutiert über den Preis.
Wenn man die 93.000 Dollar durch 45 teilt, dann kommen wir bei Provenge auf 2100 Dollar
pro Behandlung.

[GuHu1]

Antwort auf Beitrag Nr.: 41.007.458 von Kopflaus am 09.02.11 09:49:40

http://www.roswellpark.org/media/news/first-fda-approved-can…

Dr. Pili says patients will be evaluated at RPCI to ensure that they meet the eligibility requirements. These include: a diagnosis of prostate cancer that has spread to the bones or other areas outside the prostate; few or minimal symptoms of the disease; and disease that has recurred despite treatments to reduce levels of male hormones, or androgens, which help fuel the growth of prostate cancer. A study published in the July 29, 2010, issue of The New England Journal of Medicine demonstrated that Provenge significantly extended overall survival for men in this category, whose disease is incurable.

und nur dann (werden wir im july sehen) werden (wenn ja wenn) die kosten für provenge übernommen.
alles andere ist off lable und aus eigner tasche zu zahlen.

ps: viele der genannten therapien sind zu dem zeitpunkt schon gelaufen.....

[GuHu1]

http://seekingalpha.com/article/251816-dendreon-earnings-wat…

bin etwas verwirrt, im text steht märz als cms termin... weiss es einer genau?

[NoSelters]

Antwort auf Beitrag Nr.: 41.013.260 von GuHu1 am 09.02.11 21:26:44

Stammt aus nem Artikel vom November:

PROVENGE is the first in a new therapeutic class known as autologous cellular immunotherapies and is indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. On June 30, 2010, CMS initiated the NCA of PROVENGE. According to CMS, a draft guidance memo will be issued by March 30, 2011, and the expected NCA completion date is June 30, 2011.


Hmmmh...

[NoSelters]

Antwort auf Beitrag Nr.: 41.017.368 von NoSelters am 10.02.11 14:53:21

Hier noch der Link:

http://online.barrons.com/article/PR-CO-20101117-909450.html

Was bedeutet "draft guidance memo" genaqu,bzw. wie verbindlich ist das?

[Der.Eroberer]

Ich denke, das kann man mit dem FDA Panel vergleichen. Hier wird eine Empfehlung ausgesprochen und im Juni wird dann die entgültige Entscheidung veröffentlicht.

Der größere Katalyst wird die FDA-Entscheidung bezüglich der Produktionsstätte in NJ sein. Nur noch wenige Wochen...

[GuHu1]

danke ihr beiden für die richtigstellung.

[GuHu1]

Big pharma doesn't need to see any of Dendreon management's performance in a merger/acquisition analysis

I represented my department on several mergers/acquisitions and in-licensing teams in my therapeutic area in my big pharma days. A fundamental working assumption was that we could improve on any manufacturing process or any marketing performance of small biotech. This in fact is often a fundamental reason for any BP acquisition of small biotechs.

So the analysis of market penetration and sales of any acquisition target was focused on what we projected our own performance in this therapeutic area would be, not what small biotech had been able to achieve. It makes sense really, big pharma has the marketing/sales function absolutely and totally perfected, so when assessing the value of an acquisition, why focus on the marketing/sales performance statistic of small biotech?

So what I'm saying is that big pharma has no need at all to "wait and see" what kind of sales performance Dendreon can rack up for Provenge in 2011 or 12. They don't really care what Dendreon's sales team can achieve. They know what their own sales team can achieve, particularly if they are already the leader in this therapeutic area i.e. they don't need some small upstart biotech to show them what sales figures are possible!

The exact same logic applied to manufacturing process, cost of goods sold and hence profit margins. As long as our manufacturing team were familiar with the underlying manufacturing technology, it was a given that we at big pharma could do it better, more efficiently, and therefore with better margins than small biotech. So rhino pet's constant harping on profit margin is really a mute point viz a viz any big pharma's assessment of an acquisition value. We at big pharma know our own achievable manufacturing margins for any given manufacturing process. In a related topic then, there are several companies with extensive manufacturing experience in a blood product like Provenge. I worked at Bayer in the biologics division and we had several blood products which were collected through the same apheresis and cell processing procedures. I can guarantee you that Bayer would make their own projections for cost of goods sold and margins based on their own extensive experience with manufacturing blood products, and would not need to wait and see what a small upstart biotech could achieve.

So the long and short of it, IMHO, is that big pharma has no need at all to sit on the sidelines and wait to see how well Dendreon can sell and manufacture Provenge and at what margins. FDA approval of efficacy/safety and manufacturing process and CMS reimbursement approval are the green lights for any BP acquisition. So in about a month all lights will be green. Acquisition in 2011 is just as likely as 2012

http://www.investorvillage.com/smbd.asp?mb=971&mn=387547&pt=…

[pc_1262]

Hallo zusammen,
heute erhielt ich eine Nachricht von meiner Bank, dass gegen Dendreon in den U.S.A. eine Klage anhängig ist, eine sogenannte "class-action", an der ich mittels einer "proof of claim" teilnehmen könne. Info: Können alle, die im Zeitraum 29.03.2007 bis 08.05.2007 Aktien von Dendreon gekauft haben. Da ich damit nichts anfangen kann bitte ich euch Experten um Aufklärung: Ist es sinnvoll, an dieser Klage teilzunehmen, es entstehen wohl keinerlei Gerichts- oder Anwaltskosten? Weiß jemand, worum es sich bei dieser Klage handelt? Unterlagen gibt es bei:

McGuire et al. v. Dendreon Corporation
et.al., Claas Action
c/o Gilardi & Co. LLC
Notice Administrator
P.O. Box 5100
Larkspur/Ca. 94977-5100


Danke

[NoSelters]

Antwort auf Beitrag Nr.: 41.029.145 von pc_1262 am 12.02.11 12:01:31

Hier eine mässige Zusammenfassung des Sachverhaltes:

http://classactionlawsuitsinthenews.com/class-certification/…

Meines Erachtens nach chancenlos.

[NoSelters]

http://seekingalpha.com/article/252814-dendreon-teva-benefit…

[GuHu1]

Antwort auf Beitrag Nr.: 41.045.001 von NoSelters am 15.02.11 18:49:08

auch seal beach scheint auf kurs zu sein, nur der aktienkurs sieht sche*ß* aus :

http://www.sunnews.org/latest-news/seal-beach-biotech-factor…

Dendreon Corporation officials expect the Seal Beach biotech firm’s factory to be fully licensed by mid-2011.

“Construction of the Dendreon Seal Beach immunotherapy manufacturing facility is substantially complete and we anticipate licensure of the facility in mid-2011,” said Tricia Larson of Dendreon Corporate Communications in an e-mail to the Sun.

In related news, Dendreon Corporation’s fourth quarter earnings report is scheduled to be released in March.

The Seal Beach factory will make Provenge, a cancer treatment that “teaches” the patient’s immune system to fight cancer. Provenge is currently approved to treat terminal prostate cancer patients. Provenge is Dendreon’s only product at this time. ...

[GuHu1]

http://istockwizard.blogspot.com/2011/02/dendreon-corp-nasda…

[GuHu1]

http://investor.dendreon.com/releasedetail.cfm?ReleaseID=551…
_____________

heißt soviel wie:

http://www.investorvillage.com/smbd.asp?mb=971&mn=388598&pt=…

Re: median survival of patients ... in English

It's Frovenge, or frozen Provenge.
Men who signed up for the trial all had their blood drawn and sent to NJ for processing. Treatments for the control group were frozen. Treatment for those receiving treatment were injected into those patients.

Once a person in control group showed disease progression, he was given opportunity to get the Frovenge. 155 men took it, 61 men didn't want it. Those who got Frovenge lived about 20 months; those who did not elect to get Frovenge lived about 9.8 months. However, those who took it were generally healthier than those who did not. But even accounting for the difference, the results were still significant and showed a survival benefit for those getting Frovenge.

Point is, Provenge extends life by more than 4.1 months. It might be by as much as 10.2 months (or maybe even longer). Because Provenge was given to control group, it made the 4.1 month life extension result misleading. As others here have long pointed out, the study was really patients getting Provenge vs. patients getting Provenge later.

This is such good news, I predict DNDN trades to $32 by tomorrow.

[GuHu1]

http://seekingalpha.com/article/253708-good-news-for-dendreo…

[GuHu1]

http://www.minyanville.com/businessmarkets/articles/dendreon…


Dendreon Adds Ammo to Provenge Defense

When a drug maker charges $93,000 a year to treat one patient, it’s going to have some haters.

New analysis suggests that Dendreon’s (DNDN) prostate cancer vaccine Provenge may extend life as much as 10 months longer than patients who aren’t given the treatment. That’s longer than the previously reported median four months of survival benefit shown in company studies.

Since the drug was approved last year, the analysis does little more than add to the debate over cost and benefit of breakthrough treatments. Bulls continue to like Provenge and say Dendreon’s stock is undervalued. Meanwhile, that sticker price is going to continue to raise eyebrows.

Despite company research showing that the treatment extends life, the big price tag stirred much discussion last year over how much we spend as a society on life-extending drugs.

"I'd like to think cost doesn't need to come up when it's a slam dunk," H. Gilbert Welch of the Dartmouth Institute for Health Policy and Clinical Practice told the Washington Post last November. "But when it's a close call like this, it certainly has to be a factor."

The folks who decide what medicines Medicare reimburses are reviewing Provenge, a factor that’s depressing Dendreon’s stock (see Dendreon's Provenge Overhang.) The officials aren’t allowed to make a decision based on price. They say they’re merely analyzing the benefit of the treatment. In November, a panel of experts advising the bureaucrats on reimbursement recommended the vaccine be covered by the government health plan (see Dendreon Passes Medicare Test.)

Dendreon traded above $55 a share after Provenge was approved for sale in the US last spring but the Medicare review scared off some investors. The stock was little changed at $34 in midday trading Friday. Some analysts predict the shares will rise again to the mid-$50s range or even higher.

The high price of Provenge, the fear that Medicare won’t pay for the product, and concerns about manufacturing enough supply are all holding the shares back. Expect the stock to move up dramatically once there’s clarity on the government reimbursement and production. A draft decision by the Medicare officials is expected by next month. Provenge is estimated to exceed $1 billion in annual sales.

“The company has continued to hit on most all metrics and delivering on execution of sales in 2011 and toward the goal of blockbuster status into 2012 should push the stock higher this year,” RBC Capital Markets analyst Michael Yee says in a note today.

[GuHu1]

https://www.citigroupgeo.com/pdf/SNA70154.pdf

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.103.503 von GuHu1 am 24.02.11 22:58:03

Servus GuHu 1,
kannst Du mal den Text reinstellen das Link wird von meinem PC verweigert, danke!

Gruß

Fredy

[GuHu1]

Antwort auf Beitrag Nr.: 41.107.657 von Magnetfeldfredy am 25.02.11 15:29:02

Ok, bitte.

Dendreon Corporation (DNDN)
Alert: US Launch Trending Stronger; Europe Full Steam Ahead


 Launch Trending Stronger: ~$25M Provenge Sales in 4Q Indicates Strong
Patient Demand – We view $25M in sales for 4Q as indicating strong demand as
Provenge sales were near capacity. With only 25% of the NJ facility on line, mgmt
had previously indicated they will operate at the low end of their $10-$20M/mo
guidance. Given the number of holidays in 4Q as well as the east coast snowstorm
that resulted in transportation delays – we believe $25M in sales indicates strong
demand and we currently forecast $29M in sales for 1Q11. Additional NJ capacity
is expected to come on line in March and in anticipation, Dendreon has expanded
their sales force to ~100 and is in the process of adding an additional 400 sites by
the end of the year (of which ~150 may coincide with the rest of NJ).


 Europe Full Steam Ahead – Co mgmt made several comments on the call that
gives us confidence that expansion into Europe can occur in ~2-yr time frame:

– 1) After pre-submission discussions with EU National Agencies, Dendreon
believes add'l studies will not be necessary and plans to file its application for
Provenge approval in late 2011/early 2012 (after completion of tech transfer to
the CMO), with approval possibly 1H13 after a 12-18 month review;

– 2) Dendreon will be working with a Contract Manufacturing Organization (CMO)
initially to accelerate European marketing approval timeline (time saved: ~12-
18 months). We believe Dendreon has already identified the potential CMO
although it has not yet been finalized. In parallel, Dendreon will build its own
manufacturing facility (located in Germany), which is expected to be completed
and approved in 1H13 when Provenge approval is expected;

– 3) Dendreon plans to conduct a global study of Provenge in men with metastatic
hormone-sensitive prostate cancer. This is expected to be a global study and
will include patients in Europe as well as the US. We believe this study will give
European docs an opportunity to become familiar with Provenge logistics prior
to EU approval and launch. It is unclear at this time how many EU sites would
participate in this study or how many prostate cancer docs will be reached.
Discussions with regulatory authorities on study design are still ongoing.

 Capacity Constraint in Europe? – We believe the German facility will be able to
treat up to 4-8k pts/yr (vs. an est ~30k/yr eligible pts). If pricing is on par with US
pricing, this translates to $350-$700M in annual sales. We believe this facility can
geographically reach most European prostate cancer patients as Germany is
centrally located (with easy access via trains, planes and automobiles), and
capacity may be the major constraint in Europe, at least initially. Mgmt indicated
that the need and locations for additional facilities will be re-evaluated after
European launch and additional facilities could come on line in ~1 yr.

 Leveraging Existing Provenge Presence with Genitourinary Oncologists,
Bladder Cancer is Next – Dendreon plans to conduct a Ph2 study of their next
cancer immunotherapy (DN24-02 fka Neuvenge) in patients with HER2/neu+
invasive transitional cell carcinoma (aka urothelial cell carcinoma) following
cystectomy. It is estimated that ~50% of patients with advanced TCC are
HER2/neu+ and overexpression is associated with a poor outcome. According to
the SEER cancer database, in 2010 there were ~15k deaths due to bladder cancer.
Discussions on the design of the Ph2 study are still ongoing; however, we expect
primary endpoint of this study to be overall survival. Mgmt noted that expected
survival for pts with invasive bladder cancer is 18-24 months (similar to that of
metastatic hormone-refractory prostate cancer), which provides enough time for the
cancer immunotherapy to take effect while conducting a study within a reasonable
time frame. The Ph2 study is expected to enroll ~180 pts and manufacturing of
clinical product will have no impact on Provenge commercial capacity.

 Conclusions(s) – While we are encouraged by the updates on US launch and
European filing strategy, we maintain our current revenue estimates and do not yet
include the European opportunity in our model or valuation.
Dendreon Corporation (DNDN.O; US$36.20; 2S)

Valuation
Our $36 per share target price is based on using a 33x P/E multiple, the median of
the peer group, on the company’s 2014EPS estimate of $1.65 with a discount rate
of 15% per year. We use 2014 as it will be the first fully taxed year.

Risks
We believe a Speculative (S) risk rating for Dendreon is appropriate, given the
price volatility and the risk associated with PROVENGE launch.
As with any development-stage biopharmaceutical company, investing in
Dendreon involves many commercial, intellectual property (IP) and financial risks.
We believe the most important near-to-medium term downside risks consist of:

Commercial Risks — We note that the valuation for the stock is dependent on
potential revenue opportunity from PROVENGE. Specifically, if lower-thanexpected
product sales or competing products emerge, this would represent
opportunities for the stock price to not achieve our target price.

Manufacturing Risks — PROVENGE is manufactured uniquely for each patients at
Dendreon's New Jersey facility. Currently less than 25% of the NJ facility capacity
will be utilized to manufacture product as Dendreon waits for additional facilities to
come on line. If approval of these facilities were delayed, this could represent
significant negative impact on revenue potential.


Logistic Risk — Since PROVENGE is a personalized therapy, associated with a
tight timeline, there will be challenges regarding its logistics. Any hurdles in the
logistic of PROVENGE administration may negatively impact PROVENGE revenue
potential. Stability of blood samples and drug product (time from obtaining blood
sample at leukapheresis centers to Dendreon's New Jersey manufacturing facility
and infusion of PROVENGE back into patients) is limited.

Reimbursement Risk — PROVENGE is priced at $93k per patient. Dendreon will
be dependent on third-party payers, such as private insurance companies,
agreeing to reimburse patients for the costs. If third-party payers and government
health administration authorities do not reimburse or limit the amount of
reimbursement, sales would be below our expectations.

IP Risks — PROVENGE may have patent protection until 2020. The patent
position of biotechnology companies can be highly uncertain, and the company
would face the risk in obtaining and defending its key product patents. Failure to
protect its patents could negatively impact the stock price.

We believe the most important near-to-medium term upside risk to our target price
consist of:

Clinical Success — The successful development of pipeline drugs could result in
significant appreciation of the stock.

Regulatory Success — The successful regulatory approval of additional pipeline
programs, with respect to efficacy, safety and manufacturing could result in
significant appreciation of the stock.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.109.480 von GuHu1 am 25.02.11 19:19:44

Vielen Dank, hört sich gut an!

[NoSelters]

DNDN-SuperLongie in Erwartung des Conference Call:

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.124.696 von NoSelters am 01.03.11 12:53:35

Was erwartest Du genau?

[NoSelters]

Antwort auf Beitrag Nr.: 41.126.305 von Magnetfeldfredy am 01.03.11 15:49:21

Hallo Fredy,
vielleicht einen Ausblick auf die europäische Vermarktung,den Stand zu den Fabrikationsanlagen,neue geplante Studien,Jan.und Febr.-Umsätze,....

Aber egal was kommt,ich erwarte keinesfalls einen relevanten Kursanstieg....solange bis die FDA und CMS positiv entschieden haben.

Sei es drum,wir warten jetzt schon sooo lange,da kommts auf ein paar weitere Monate nicht an.Ich habe eh nicht vor alle Shares zu verkaufen. In fünf Jahren werde ich immer noch Aktionär sein....wenn bis dahin kein Verkauf stattgefunden hat.


So loooong...

[GuHu1]

March 1, 2011
Dendreon Reports Fourth Quarter and 2010 Year End Financial Results
Conference Call to be Hosted March 1, 2011 at 4:30 p.m. ET

SEATTLE, March 1, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN) today reported results for the year and quarter ended December 31, 2010. Revenue for the year ended December 31, 2010 was $48.1 million compared to $0.1 million for the year ended December 31, 2009. Revenue for the fourth quarter of 2010 was $25.0 million compared to $21,000 for the quarter ended December 31, 2009.

The net loss for the year ended December 31, 2010 was $439.5 million, or $3.18 per share, compared to $220.2 million, or $2.04 per share for the year ended December 31, 2009. This loss in 2010 includes a non-cash fair value adjustment of $142.6 million or $1.03 per share associated with a change in the fair value of our warrants, compared with a non-cash fair value adjustment of $118.8 million, or $1.10 per share for the year ended December 31, 2009. The size of this re-measurement is directly related to the price increase our common stock experienced this year. Net loss in the fourth quarter of 2010 was $91.8 million or $0.64 per share, compared to a net loss of $32.5 million, or $0.28 per share, for the same period in 2009. Dendreon's total operating expenses for the year ended December 31, 2010 were $311.7 million compared to $100.1 million in 2009.

As of December 31, 2010, Dendreon had approximately $277.3 million in cash, cash equivalents, and short-term and long-term investments compared to $606.4 million as of December 31, 2009 (excluding the $607.3 million raised in January 2011).

Recent Highlights:

* Raised net proceeds of $607.3 million through an offering of convertible senior notes to support U.S. commercialization and advance European regulatory and manufacturing plans
* Submitted a post-approval supplement for PROVENGE® (sipuleucel-T) requesting licensure of 36 additional work stations to manufacture PROVENGE in the New Jersey facility
* Submitted a post-approval supplement on February 28, 2011 for PROVENGE requesting licensure of 36 work stations in the Los Angeles facility to manufacture PROVENGE
* Announced plans to seek European marketing authorization for PROVENGE with an anticipated filing by end of 2011/early 2012
* Secured acceptance from the U.S. Food and Drug Administration for the Investigational New Drug application for DN24-02 for the treatment of invasive bladder cancer and expect to begin enrolling patients in the second half of 2011


"In 2010, we began to establish PROVENGE as the foundation of care," said Mitchell H. Gold, M.D., president and chief executive officer. "As we look to 2011, it will be a year of both execution and a year of growth for Dendreon, all of which is designed with a single goal in mind: to help patients with cancer live longer and live better lives."

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.129.232 von GuHu1 am 01.03.11 21:31:26

Der CC war ok, jedoch gibt es viel Unsicherheit in meinen Augen bzgl. der Erstattung!
On label Entscheidung ist schon eingepreißt, wie gehts weiter?
Auch die monatlichen Revenues wurden nicht mehr mitgeteilt, bzw. die vorhandenen Rezepte!

[GuHu1]

Antwort auf Beitrag Nr.: 41.140.347 von Magnetfeldfredy am 03.03.11 13:57:27

Der CC war ok, jedoch gibt es viel Unsicherheit in meinen Augen bzgl. der Erstattung!
On label Entscheidung ist schon eingepreißt, wie gehts weiter?

folgend meine persönliche meinung:
kann ja nicht eingepreist sein, wenn die unsicherheit darüber besteht.auch muss dendreon beweisen das sie die nachfrage erfüllen können. wäre somit der zweite unsicherheits faktor. 100% nj approval, sowie ausbau und zulassung der weiteren 2 werke. dh. ausbau der produktionskapazität von 12 (derzeit) auf 48 (100% nj) über 1 x 38 (ca. july) und 1 x 38 ( letztes quartal)auf 120 produktionsplätzen.

ob und wie sich das auf den kurs auswirkt.... sollte eigendlich positiv gewertet werden.
anbei die einschätzung der db:
http://www.investorvillage.com/smbd.asp?mb=971&mn=391013&pt=…

[GuHu1]

hakurs chart:

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.143.303 von GuHu1 am 03.03.11 19:52:03

Danke, gutes Modell!
Mir hätte gefallen das Dendreon sagt, Sie hätten tausende Rezepte die abgearbeitet werden müssen! Ich glaube bis zur CMS Entscheidung gibt es gar nicht so viele Rezepte!

Bei On-Label Erstattung (davon gehe ich aus) ist meine Frage ob der Bedarf hoch genug ist um alle Anlagen voll auszulasten, was meinst Du?

Time will tell us!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.144.909 von Magnetfeldfredy am 04.03.11 07:32:30

Gute Zusammenfassung, oder:

Dendreon Loss Widens on Higher Costs

ShareretweetEmailPrintZacks Equity Research, On Wednesday March 2, 2011, 10:00 am EST

Dendreon Corporation’s fourth quarter 2010 loss of 61 cents per share (excluding loss on debt conversion) was wider than the Zacks Consensus Estimate of a loss of 48 cents per share and the year-ago loss of 31 cents per share (excluding gain for warrant revaluation).

On a reported basis (including special items), the company lost 64 cents per share in the fourth quarter as against a loss of 28 cents in the year-ago quarter. The wider loss was attributable to higher operating expenses as the company is working on expanding its facilities to market Provenge.

For full year 2010, Dendreon reported loss per share of $2.11 (excluding loss on debt conversion and warrant revaluation), wider than a loss of 94 cents per share in 2009 but narrower than the Zacks Consensus Estimate of a loss of $3.01. Full year 2010 revenues of $48.1 million were well above the prior-year figure of $101,000.

Quarterly Details

Total revenue in the reported quarter climbed to $25.0 million (entirely from Provenge indicated for the treatment of advanced prostate cancer) from $21,000 in the comparable quarter of 2009. The jump was attributable to the successful launch of Provenge. The potential blockbuster drug performed well in its second full quarter after launch in May 2010.

Unlike traditional vaccines that prevent diseases, Provenge treats by stimulating the body's own immune system to attack cancer cells. Provenge is the first product in the new therapeutic class known as active cellular immunotherapies (ACI).

Dendreon’s total operating expenses for the quarter swelled 169.0% to $97.9 million due to increased manufacturing and commercialization activities for Provenge in the US.

2011 Guidance

Provenge revenue guidance, for 2011, was reiterated at $350–$400 million with approximately half of the sales expected in the final quarter of the year.

Dendreon also expects to incur an adjusted net loss of $230–$270 million including $90 million in start-up costs associated with the US manufacturing facilities. The company expects to spend approximately $60 million in the EU and $80–$120 million (excluding the $90 million start-up costs) for Provenge commercialization activities.

US Commercialization Efforts

Dendreon is working towards expanding its manufacturing facilities for Provenge in the US. The company’s New Jersey facility, which is currently operating at 25% capacity (12 workstations), is expected to be fully operational (48 workstations) by March 2011. The company is also building capacity at two facilities in Atlanta, Georgia and Los Angeles (LA), with each having 36 workstations. Dendreon is seeking approval for its Atlanta facility and has filed a post-approval supplement for FDA approval of the LA facility. These facility expansions would drive a ten-fold increase in capacity in 2011. The company has earmarked $90 million to bring these facilities online.

In the drive for commercialization, the Provenge sales force is being bolstered to 100 representatives who will target 500 centers (where patients can be treated with Provenge) by the end of 2011, well above the current 50 centers. The company will also increase its marketing efforts to maximize the available capacity. Dendreon now has all 15 US Medicare contractors providing reimbursement for Provenge.

EU Strategy

The company plans to file a Marketing Authorization Application (MAA) for Provenge in the European Union in late 2011/early 2012. Dendreon expects to build its own manufacturing facility in Frankfurt, Germany given its central location and proximity to key places where the majority of the addressable patient population reside.

Other Updates

Dendreon announced plans to start phase II studies of Neuvenge (DN24-02), the company’s second ACI candidate that targets Her2+ in invasive bladder cancer soon. The company filed an Investigational New Drug Application (IND) in December 2010. The study will enroll 180 patients with the primary endpoint being overall survival.

Our Recommendation

We currently have a Neutral rating on Dendreon. We believe Provenge has blockbuster potential and its successful commercialization should push Dendreon towards profitability. We are also encouraged by the upbeat commercial and regulatory update. On a more cautious note, we remain concerned about the company’s dependence on Provenge and the lack of a robust pipeline. Dendreon has little to fall back on if Provenge’s performance belies its potential. We therefore prefer to be Neutral on the company.


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[GuHu1]

Antwort auf Beitrag Nr.: 41.145.256 von Magnetfeldfredy am 04.03.11 08:46:15

hi freddy,
was noch bemerkenswert ist, die analyse der db sagt folgendes zu den centren:

Company has guided they currently have many online(like more than 70), but they said they plan to have 225 online by end of 2Q (this is june)

für märz wurden von db mit 100 kalkuliert, dndn vermeldete gestern 200!

von der seite scheint alles im lot, zulassung der 100% nj + cms entscheidung stehen für märz an.

[GuHu1]

Antwort auf Beitrag Nr.: 41.145.256 von Magnetfeldfredy am 04.03.11 08:46:15

das eine noch und dann halt ich mich zurück.


......Email from IR-FWIW:
In our March 1 call we said that we expect cms will support on-label access to patients in our labeled indication. We expect to see the facility approved. We expect to hear from the FDA in mid March. We're focusing on execution and eventually the stock price should follow.
Susan Specht, Investor Relations, Dendreon....

http://www.investorvillage.com/smbd.asp?mb=971&mn=391485&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.151.018 von GuHu1 am 04.03.11 20:51:34

Danke, guad Nacht!

[GuHu1]

Antwort auf Beitrag Nr.: 41.151.610 von Magnetfeldfredy am 04.03.11 23:48:45

ja, hab noch was zum lesen gefunden......

http://www.deepcapture.com/wp-content/uploads/2009/10/story-…

[Der.Eroberer]

Anbei der Link zu dem Transcript Earnings Call Q4/2010:

http://www.morningstar.com/earnings/22848088-dendreon-corpor…

Sollte man sich zu Gemüte führen. Keinerlei Bedenken bezüglich der Zulassung von NJ auszumachen...

[GuHu1]

Antwort auf Beitrag Nr.: 41.156.190 von Der.Eroberer am 07.03.11 09:20:11

hakur

http://www.fotos-hochladen.net/uploads/dndnmonthba23yunxoz.p…

http://www.fotos-hochladen.net/uploads/dndnmonthdetars7yivhu…

[GuHu1]

Antwort auf Beitrag Nr.: 41.167.245 von GuHu1 am 08.03.11 20:37:03

oder so



http://www.fotos-hochladen.net/uploads/dndnmonthdetars7yivhu…

[NoSelters]

Antwort auf Beitrag Nr.: 41.167.256 von GuHu1 am 08.03.11 20:38:51

Ergänzend noch seine Analyse:

Re: Beneath $ 30.-?


--As one can see since the highs chart has formed a nice falling wedge and the maximum lows in between the green legs as in this chart can be circa $31.40--

Wasn`t here for a while, coming back just now and saw that shorty crooks did play again hardball.


ull range was Hope nobody here has set a stop, no margin! From TA side the full range of the falling wedge they

used! Wan`t expect a lower from that point we are. But who knows;-)

I`m for myself often surprised how TA works when looking at the triangle, don`t ask me why but works.


Best to you ALL ( Whithout crooks ;-( )

[GuHu1]

Antwort auf Beitrag Nr.: 41.167.300 von NoSelters am 08.03.11 20:47:09

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.167.318 von GuHu1 am 08.03.11 20:51:16

Good news:

Dendreon Expands Launch of PROVENGE
-FDA Approval of Additional 36 Workstations in New Jersey Manufacturing Facility Provides Increased Availability of First-in-Class Prostate Cancer Immunotherapy PROVENGE-


ShareretweetEmailPrintCompaniesendreon Corporation Related Quotes
Symbol Price Change
DNDN 32.45 +0.23


{"s" : "dndn","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Dendreon Corporation On Thursday March 10, 2011, 2:17 pm
SEATTLE, March 10, 2011 /PRNewswire/ -- Dendreon Corporation (NasdaqNDN - News) announced today that the U.S. Food and Drug Administration (FDA) approved the remainder of its New Jersey manufacturing facility, allowing the company to significantly increase the availability of PROVENGE® (sipuleucel-T) to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

Last April, upon receiving FDA approval of PROVENGE, Dendreon launched the world's first patient-specific prostate cancer immunotherapy from 12 workstations in its New Jersey facility. With the FDA approval of 36 additional workstations, the New Jersey facility will now have a total of 48 approved workstations. Dendreon will bring these new workstations online in a staged approach.

PROVENGE is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class of drugs known as autologous cellular immunotherapies.

"PROVENGE has the largest reported survival benefit in patients with asymptomatic or minimally symptomatic metastatic prostate cancer, with the most common side effects being primarily transient and mild to moderate. As such, PROVENGE is the standard of care for these patients," said Daniel George, M.D., director of GU Medical Oncology and the Prostate Clinic at Duke University Medical Center. "The increased availability of PROVENGE will allow more treatment centers and patients across the country to access this important treatment option."

In anticipation of the availability of the additional workstations, Dendreon expects to have approximately 225 infusion centers prepared to treat their first patient by the end of the second quarter, approximately 450 infusion centers upon entering the fourth quarter, and approximately 500 by the end of 2011.

PROVENGE was approved based on three Phase 3 studies, including the pivotal, 512-patient Phase 3 IMPACT study, which showed that PROVENGE demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (CRPC). That trial showed PROVENGE extended median survival by 4.1 months compared to control. Overall, PROVENGE reduced the risk of death by 22.5 percent compared to the control group (HR=0.775). Results from the similarly designed Phase 3 Study D9901 in asymptomatic metastatic CRPC also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.

"The significant 4.1 month median survival benefit PROVENGE demonstrated represents a major milestone in the treatment of metastatic CRPC. To put PROVENGE in perspective, over the past 15 years, there have only been three other therapies in any metastatic cancer setting to show a survival benefit of four months or more," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "With FDA approval of the additional NJ workstations, we now have significant capacity to make this important therapy available to the many men across the U.S. who may benefit from it."

Dendreon expects to continue to provide additional capacity through the anticipated licensure of its two other manufacturing facilities. Dendreon filed a post-approval supplement on February 28, 2011, requesting licensure of 36 work stations in its Los Angeles facility to manufacture PROVENGE and expects a decision in mid-2011.

Dendreon also plans to file a post-approval supplement for its third facility in Atlanta, which is expected to come online in mid-2011.

PROVENGE Indication and Safety

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

For more information on PROVENGE, please see the full prescribing information or call Dendreon ON Call at 1-877-336-3736.

About Prostate Cancer

According to the American Cancer Society, prostate cancer is the most common non-skin cancer in men in the United States and the third most common cancer worldwide. More than two million men in the United States have prostate cancer, with an estimated 217,730 new cases and approximately 32,050 men expected to die from the disease in 2010.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon's first autologous cellular immunotherapy product, PROVENGE® (sipuleucel-T), was approved by the FDA in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer. The Company is headquartered in Seattle, Washington and has manufacturing facilities in New Jersey, Georgia and California. Dendreon is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.

This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon's business and prospects, including commercialization of PROVENGE. Information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.


Follow Yahoo! Finance on Twitter; become a fan on Facebook.

[alabama76]

Dendreon steigt entgegen dem breiten Markt langsam wieder. Vermutlich, weil aufgrund der radioaktiven Strahlung langfristig mit mehr Krebsfällen gerechnet wird? Was meint ihr?

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.205.976 von alabama76 am 15.03.11 11:50:08

Könnte sein, kann aber auch sein, daß mit den Amis auch Dendreon heute den Bach runter geht!

[GuHu1]

Antwort auf Beitrag Nr.: 41.205.976 von alabama76 am 15.03.11 11:50:08

ne ne,
das hat nichts mit den aktuellen vorgängen in japan zu tun.
liegt eher am ausbau von nj auf 100% = 48 worstations was bedeutet das die rahmenbedingungen der weitern werke scheinbar gut handelbar sind.

das wirkt sich derzeit meiner meinung nach positiv auf den kurs aus.

[GuHu1]

Antwort auf Beitrag Nr.: 41.206.588 von Magnetfeldfredy am 15.03.11 12:43:29

hoffentlich nicht.....

[ditzeroni]

Wie die korrupten FDA-Penner damals in 2007 zehntausenden Patienten Provenge vorenthalten haben sollte ja jedem hier bekannt sein.
Hier nochmal ein guter kurzer Überblick, wer damals mit wem zusammen gegen DNDN intregiert hat, um Provenge vom Markt fernzuhalten:
http://caretolive.com/wp-content/uploads/2008/05/players_pro…

Wen es ganz genau interessiert und wer mal etwas Zeit hat:
http://www.deepcapture.com/michael-milken-60000-deaths-and-t…

Ich kann es nur empfehlen, sich das mal durchzulesen. Dann versteht man auch viel mehr von den Dingen, die bei der FDA und der SEC so vor sich gehen.

[huetchen6]

Antwort auf Beitrag Nr.: 41.206.588 von Magnetfeldfredy am 15.03.11 12:43:29

Hallo, da ist was dran, glaube schon das man jetzt noch gezielter an das Immunsystem
ran geht, und das kommt so, da wird auch die Dendreonaktie kurzfristig darunter leiden,durch Erfolgideen, das wäre dann ein neuer Schub, ansonsten glaube ich an den Aktienkurs von Dendreon nicht mehr, hier werden nur noch die Sponsoren in alle Richtungen die für den Erfolg beigetragen haben, beglückt.
huetchen

[trade4profit]

Man sollte auf jeden Fall Prima Biomed im Auge behalten. Sieht ganz so aus als ist sie die naechste Dendreon. Die Entwicklung ist sehr positiv und recht rasant. Jetzt nur sehr neugierig was mit Nasdaq passiert.

Regards, trade4profit

[trade4profit]

http://www.dailyfinance.com/story/investing/inside-wall-stre…

[GuHu1]

http://www.nature.com/naturejobs/2011/110324/full/nj7339-537…

[ditzeroni]

Super Video!
Ein Patient bekommt Provenge verabreicht und gibt nebenher ein Interview.
Ein Arzt kommt locker vorbei geschlendert und fragt ihn, ob alles ok ist.
Der Patient antwortet: Mir gehts gut, Doc!
Arzt: ..hab auch nix anderes erwartet!..
und schlendert locker weiter..

Außerdem hab ich im ganzen Video nicht einmal gehört, das Provenge $93K kostet für lumpige 4 Monate extra Leben; den üblichen Scheiß halt, den sonst immer alle von sich geben.

http://www.digtriad.com/news/health/article/168046/8/New-Tre…

[Poppholz]

J.P. Morgan Reiterates OW Rating On DNDN
By BenzingaStaffL
March 28, 2011 7:16 AM

J.P. Morgan is reiterating its OW rating on Dendreon Corp. (NASDAQ: DNDN) “ahead of the anticipated CMS memo regarding the ongoing National Coverage Analysis of Provenge, which is expected later this week (by Wed March 30).”

“We believe the Street broadly shares our view and expects confirmation that Provenge will continue to be reimbursed according to the labeled indication (asymptomatic and minimally symptomatic castrate resistant prostate cancer),” J.P. Morgan writes.

“Nevertheless, we still consider this another meaningful de-risking event (on top of the recent manufacturing progress). There also could be incremental buyers waiting for this important box to be checked. DNDN remains our top pick.”

Dendreon closed Friday at $32.95.

http://www.benzinga.com/analyst-ratings/11/03/955546/j-p-mor…

[GuHu1]

Dendreon Expected to Get Positive Medicare Ruling
By Brett Chase Mar 28, 2011 11:45 am
Ruling by Medicare officials should remove overhang on the stock.

There’s a high probability that Dendreon’s (DNDN) prostate cancer treatment Provenge will get a positive ruling this week from the folks who determine Medicare reimbursements.

That’s the prediction from RBC Capital Markets analyst Michael Yee, who rates the stock a buy and sets a 12-month price target of $50 on the shares.

Yee estimates there is only a 15% to 20% chance the Centers for Medicare and Medicaid Services will either delay a ruling or choose not to pay for Provenge. In other words, bet on a favorable ruling because it should eliminate a serious drag on the stock. The agency is due to make its preliminary decision, issuing draft guidance by Wednesday. A final ruling comes June 30.

“A positive memo should remove another overhang and clear the decks for the company to continue to execute this year,” Yee says.

Yee and other analysts say Provenge, a vaccine that triggers the body’s immune system to attack cancer cells, will be a blockbuster drug exceeding $1 billion in sales. Unlike a number of other smaller biotech companies, Dendreon was able to bring the treatment to market by itself and doesn’t have to share sales with a drug development partner.

Dendreon’s stock surged last year, topping out above $55 after the Food and Drug Administration approved Provenge. But the stock took a hit after Medicare officials said they were reviewing the treatment. The shares traded at $34, up 3%, in morning trading Monday. They’ve dropped 19% in the past six months.

Medicare coverage is crucial as a large population of prostate cancer patients count on the government health plan for seniors. Private insurers often look to Medicare to determine coverage and reimbursement. Medicaid is the US health plan for low income patients and is administered by the same agency that oversees Medicare.

In November, a panel of government advisers recommended that the US health plans pay for Provenge because it extended lives of patients with advanced stages of the cancer. (See Dendreon Passes Medicare Test.)

The government and private health insurers currently are paying for the treatment.

Although the stated purpose of the government review was to determine if Provenge was an effective drug worth reimbursing, the process raised questions whether the agency was scrutinizing the treatment because of its price (even though that isn’t supposed to be the criteria).

Provenge costs $93,000 per regimen -- three treatments. That’s about twice the cost of some traditional treatments commonly used for prostate cancer, consultant Michael Becker says.

However, Provenge doesn’t require multiple regimens. And it lacks some of the serious side effects common with radiation or chemotherapy, Becker adds. Those treatments can require additional patient care.

“We believe that the market opportunity for Provenge is significant as a unique agent with demonstrated survival benefits and mild toxicity in the large population of prostate cancer patients who currently have limited options,” Leerink Swann analyst Howard Liang says in a recent note. He recommends buying the stock and has a $55 price target.

http://www.minyanville.com/businessmarkets/articles/endreon-…

na ja wir werden sehen wohin die reise geht.

[NoSelters]

Gold verkauft wieder mal im grossen Stil,
Shortquote steigt auf über 14 Mio. und die Analysten empfehlen auf Teufel komm raus.



Was uns wohl heute erwartet?

Good luck allen Longies...

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.287.634 von NoSelters am 30.03.11 10:31:13

This is Dendreon!
Gold hat 19.000 Stück verkauft, automatic sale, aber er hat ja noch 540.000, muß nicht viel heißen wenn er Steuern sparen wollte aber äußerst schlechter Zeitpunt!

[GuHu1]

Antwort auf Beitrag Nr.: 41.288.700 von Magnetfeldfredy am 30.03.11 12:38:36

wohl war, aber die kernaussage ist ja automatic sale.
hat er sich diesen zeitpunkt ausgesucht??

[ditzeroni]

CMS - reasonable & necessary
Avatar BiotechStockRsr CMS: "reasonable and necessary for the indication" $DNDN Mar. 30 at 4:05 PM

Avatar BiotechStockRsr CMS: "Improves health outcomes for Medicare beneficiaries" $DNDN Mar. 30 at 4:05 PM

BiotechStockResearch
BiotechStockRsr BiotechStockResearch
Off label use of Provenge left up to local subcontrators. CMS does NOT prohibit off label coverage. $DNDN
2 minutes ago Favorite Retweet Reply

[NoSelters]

Antwort auf Beitrag Nr.: 41.292.824 von ditzeroni am 30.03.11 22:15:54

The Centers for Medicare and Medicaid Services (CMS) proposes that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication under 1862(a)(1)(A) of the Social Security Act (the Act).

We are requesting public comments on this proposed determination pursuant to section 1862 (l) of the Act. After considering the public comments, we will make a final determination and issue a final decision memorandum.

[NoSelters]

Antwort auf Beitrag Nr.: 41.292.833 von NoSelters am 30.03.11 22:16:54

Sorry,vergass die Quelle:

http://ht.ly/4ptXs

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.292.851 von NoSelters am 30.03.11 22:19:37

Yes!:

Dendreon $93,000-a-Year Prostate Cancer Drug Backed for Medicare Coverage
By Catherine Larkin - Mar 30, 2011 10:22 PM GMT+0200 inShare0More
Business Exchange Buzz up! Digg Print Email Dendreon Corp. (DNDN)’s prostate cancer drug Provenge should be covered by the U.S. government for use in older men, regulators said.

The $93,000 drug regimen is “reasonable and necessary” for men with advanced, castrate-resistant prostate tumors who have minimal or no symptoms of the disease, the Centers for Medicare & Medicaid Services said today in a proposed decision memo. The proposal is in line with the approved prescribing information.

The decision is critical for Seattle-based Dendreon as three-quarters of the men approved for Provenge are eligible for Medicare because they are 65 years old or older. Investors’ skepticism that Dendreon wouldn’t win reimbursement or be able to satisfy demand for the drug has pushed shares below the traded price before Provenge was cleared for sale on April 29.

“That weakness should reverse over the next year because they will now be in an unconstrained environment,” said Michael Yee, an analyst at RBC Capital Markets in San Francisco, in a telephone interview before the announcement. “Once they execute on sales, people will see the true potential of this drug.”

Medicare coverage will help Provenge generate $2.3 billion in sales in 2014, according to the average estimate of four analysts surveyed by Bloomberg.

Shares Rise
Dendreon rose 43 cents, or 1.2 percent, at 4:16 p.m. New York time in extended trading. The shares earlier fell 34 cents, or 1 percent, to $35.54 at the close of Nasdaq Stock Market composite trading. Dendreon has dropped 36 percent from a peak of $55.43 on May 3.

The Baltimore agency that regulates Medicare coverage began its review of Provenge on June 30 after regional contractors voiced concerns about potential use beyond the approved patient population. While the 15 local plans currently are paying for the drug, supplies have been limited. Dendreon aims to open new plants this year.

The American Cancer Society estimated that 217,730 U.S. men would be diagnosed with prostate cancer last year and 32,050 men would die of the disease. Symptoms typically start when patients have less than a year to live. Of more than 1 million men with the disease, about 70,000 qualify for Provenge, according to Robyn Karnauskas, an analyst at Deutsche Bank Securities in New York.

Immune System Response
Provenge is the first medicine that trains the body’s immune system to attack cancer cells as it would a virus. The therapy involves extracting white blood cells from a patient, mixing them with vaccine components and delivering the combination as an infusion. Treatment lasts one month with three doses, each given two weeks apart.

Studies supporting Provenge approval showed the drug helped men with prostate cancer live four months longer on average.

Outside advisers to Medicare said in November that they were confident that Provenge significantly improved survival in men with advanced tumors. The 10-member panel rated their confidence in the survival benefits a 3.6, on average, on a 1 to 5 scale with 5 being the most confident.

No cure exists for advanced prostate cancer that has spread outside the prostate gland. Patients often are given hormone therapy or chemotherapy drugs such as Paris-based Sanofi-Aventis SA (SAN)’s Taxotere or Jevtana. Those drugs improved survival by 2.4 months in studies and are linked to higher rates of side effects and longer treatment regimens than with Provenge.

To contact the reporter on this story: Catherine Larkin in Washington at [e-mail].

To contact the editors responsible for this story: Adriel Bettelheim

[GuHu1]

Antwort auf Beitrag Nr.: 41.292.913 von Magnetfeldfredy am 30.03.11 22:33:33

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=396005&pt=…

OFF LABEL USE:

While we may nationally noncover items and services that fail to demonstrate achievement of the “reasonable and necessary” statutory requirement, we may also leave it to our local administrative contractors to implement noncoverage. In this case we propose the latter, for the following reasons.

Autologous cellular immunotherapy is a new paradigm in the treatment of cancer, and we do not yet know if the development of additional evidence will follow the same trajectory as manufactured pharmaceutical products. Should the pace of evidence development for these products prove to be faster-paced and indicative of improved health outcomes, we believe that preserving local contractors’ ability to quickly broaden coverage within their jurisdictions will hasten beneficiary access.

If future evidence demonstrates improvement in patient health outcomes as a result of incremental improvement(s) to the current labeled process, we want our administrative contractors to have the flexibility to determine local coverage without the need to reconsider an NCD.

[GuHu1]

Deutsche Bank

CMS language is less restrictive on off-label use of Provenge.
In the NCA memo, CMS points out that there is no mature efficacy data that
supports off-label use of Provenge. However, the agency is leaving it to
local physicians to use Provenge off-label on a case by case basis. This
language is less restrictive than what the Street was expecting.

Although less restrictive - CMS can pull the plug if off-label use is great.
CMS hopes that the vast majority of off-label use occurs in clinical trials.
However, if the soft language used in today's memo, leads to substantial
off-label use, CMS would reconsider the NCD to make sure Provenge is only used on-label.

Why is CMS doing this?
It appears that CMS is being less restrictive because it is awaiting results
of ongoing trials that are evaluating Provenge in earlier settings of prostate
cancer. If these trials are successful, it does not want to have to revise a
restrictive NCD. Hence, by using less restrictive language now, it will not
need to revise if positive data emerges. Revising an NCD can be a long
process and would restrict physicians from using Provenge in earlier settings
of prostate cancer during the revision process.

We are not increasing Provenge sales numbers but view as incremental
positive for DNDN shares.
We reiterate our Buy rating & $54 TP.

http://www.investorvillage.com/smbd.asp?mb=971&mn=396397&pt=…" target="_blank" rel="nofollow ugc noopener">
http://www.investorvillage.com/smbd.asp?mb=971&mn=396397&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.300.374 von GuHu1 am 31.03.11 22:49:48

[GuHu1]

Antwort auf Beitrag Nr.: 41.300.394 von Magnetfeldfredy am 31.03.11 22:52:34

[ditzeroni]

Und es spricht sich immer weiter rum..
http://www.youtube.com/watch?v=Mbw8Hs9NJT0&feature=player_em…

Aber all diese kleinen Videos und News in lokalen TV-Sendern und Radiostationen werden mM nach nicht annähernd soviel ausmachen wie die Mund-zu-Mund Propaganda in einiger Zeit. Sobald die ersten paar Tausend Männer behandelt wurden, und die in ihrem Familien-/Bekanntenkreis davon erzählen, dann gehts erst richtig los!
Hätte PC so eine große Lobby wie Brustkrebs, sähe es jetzt schon ganz ander aus, aber so dauert es halt ein wenig.
Solange die Kapazitäten sowieso komplett ausgelastet sind, ist es ja auch nicht so schlimm. Wie ich bereits erwähnte, gehe ich von weiteren Fabriken in den USA in den nächsten 2-3 Jahren aus.
Sobald die Daten von NeoAct und P11 kommen, wird auch klarer was mit off-label ist. Je länger wir auf die Daten von P11 warten müssen, umso besser werden sie, vorraussichtlich Mitte 2012 werden wir erst das nächste Mal Daten bekommen.

[ditzeroni]

http://blogs.forbes.com/jamesaltucher/2011/04/05/four-billio…

http://seekingalpha.com/article/261851-interview-immunocellu…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.322.274 von ditzeroni am 05.04.11 17:16:32

Die Milliardäre kaufen jetzt, wir kauften schon bei US Dollar 4-5!

[GuHu1]

Antwort auf Beitrag Nr.: 41.322.386 von Magnetfeldfredy am 05.04.11 17:26:49

wie viele aktien sind short? 14 + x mios

[Poppholz]

Antwort auf Beitrag Nr.: 41.323.217 von GuHu1 am 05.04.11 19:15:26

bist Du mit 14 Aktien short?

(sorry, war Spass, passt aber so schön)

[ditzeroni]

Antwort auf Beitrag Nr.: 41.323.217 von GuHu1 am 05.04.11 19:15:26

Shortinterest:
http://www.nasdaq.com/aspxcontent/shortinterests.aspx?symbol…

Dendreon Corporation (DNDN) Short Interest
DNDN
Dendreon CorporationNASDAQ-GS
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
3/15/2011 14,293,917 3,613,893 3.955268
2/28/2011 13,776,939 3,098,368 4.446515
2/15/2011 14,458,708 2,082,028 6.944531
1/31/2011 15,599,259 2,953,512 5.281597
1/14/2011 12,963,904 4,214,509 3.076018
12/31/2010 12,505,464 1,799,146 6.950778
12/15/2010 12,281,281 2,202,841 5.575201

[GuHu1]

http://www.twst.com/yagoo/yeemichael1234.html

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=397431&pt=…

[crivit]

Ich hoffe die alten Hasen sind noch dabei!
Jetzt geht die Party erst richtig los!
LONG and STRONG
GLTA

Gruß
Crivit

[crivit]

Weil es so schön ist! ;-)

[GuHu1]

Antwort auf Beitrag Nr.: 41.342.174 von crivit am 08.04.11 18:46:40

LONG and STRONG
yep was mich angeht.

[brazzo007]

http://seekingalpha.com/article/262803-why-provenge-could-be…

[Fruehrentner]

Antwort auf Beitrag Nr.: 41.348.692 von brazzo007 am 11.04.11 14:06:39

http://seekingalpha.com/article/262803-why-provenge-could-be…

[GuHu1]

auch nett.......

http://www.empowher.com/cancer/content/prostate-cancer-fight…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.351.553 von GuHu1 am 11.04.11 22:58:54

Wow, deutlich über 40, go Dendreon go!

[GuHu1]

Antwort auf Beitrag Nr.: 41.368.536 von Magnetfeldfredy am 14.04.11 16:22:29

treib little debbie nicht zu stark an, wird schon.
2 der unsicherheits faktoren die du erwähntest ( nj + cms ) scheinen geklärt, jetzt gehts ans beweisen. ist die nachfrage an provenge tatsächlich hoch und kann dndn diese befriedigen.

[crivit]

Sehr schöner Verlauf heute!
Morgen ist ja Freitag, mal schauen was die Amis daraus machen.

[GuHu1]

.......
TWST: You also mentioned Dendreon.

Mr. Yee: Dendreon got their drug, Provenge, approved by the FDA in the middle of 2010 to treat prostate cancer, which demonstrated a robust four months survival benefit. They went from being on the verge of having a drug that did not look like it was going to get approved to now having that drug approved and the potential to be a multibillion-dollar commercialized product. I think that there are a couple of things going on here which make the stock look very attractive. Number one, there is still some skepticism that remained as to whether there is going to be strong demand for this drug, but based on our conversation with physicians I think that there is very solid demand over the next one to two years for Provenge.

I think that guidance is beatable assuming reasonable execution. Secondly, I think that the stock should appreciate because it's had a pullback recently. But I think that as we get through Q2, Q3 and Q4, and execute and by meeting those estimates, I think the stock will go up and people will get more comfortable with demand as well as comfort that this company can execute. Third, I think that demonstrating continued solid demand over next one or two years as well as potentially getting European approval in later 2012, which is not in estimates, is upside. And I think their valuation is very attractive because it owns 100% proprietary rights to this blockbuster drug, which is also very unique in biotech, and it has 1 billion or 2 billion drug on its hands, but only a 5 billion market cap..........

http://www.twst.com/yagoo/yeemichael1234.html

[GuHu1]

By: LYNNE JETER
Posted: Tuesday, April 12, 2011 5:29 pm

Gaining Hope

Prostate cancer patient Michael Mead of Orange Park was running out of options when doctors recommended him as a candidate for the innovative Provenge® treatment developed by Seattle, Wash.-based biotech company, Dendreon Corporation (NASDAQ: DNDN).

Since doctors diagnosed Mead with prostate cancer in 2004, he had tried radiation treatments, which failed after two years. He participated in various clinical trials at Johns Hopkins Medical Center in Baltimore, Md., but became hormone resistant, thus limiting the effective treatment available to him. The cancer continued to grow aggressively, producing two cancerous spots in the lymph nodes near his lower left kidneys.

Doctors were carefully monitoring the location with CT scans to ensure that the cancer had not metastasized and spread to his bones when the innovative medical therapy became available for Mead as the first FDA-approved autologous cellular immunotherapy A treatment that stimulates the immune system to provide protection against disease. that stimulates a patient’s own immune system to target and attack prostate cancer.

The treatment called for Mead to have a group of his white blood cells—mononuclear cells—drawn at Florida’s Blood Centers (FBC) in Orlando through a process called leukapheresis. Once these immune cells are collected, they’re immediately shipped to Dendreon.

“This is cutting-edge medical technology,” said Tisha M. Foster., MD, chief medical affairs officer for FBC. “Our main objective is to supply blood to our community’s hospitals, but it is an added benefit of our work to be directly involved with a patient’s treatment.”

The dosage was administered to Mead within 72 hours of cells extraction at FBC in Orlando. This process was repeated in two additional sessions over six weeks.

“This revolutionary treatment opens up the area of personalized medicine where you can get the right drug to the right individual to treat the right condition,” said FBC medical director Richard R. Gammon, MD.

Mead and his doctors are optimistic the Provenge treatment will stabilize the disease.

http://orlandomedicalnews.com/gaining-hope-cms-1234

[GuHu1]

http://www.9news.com/news/article/195457/188/New-drug-treatm…

[GuHu1]

http://www.deepcapture.com/the-miscreants-global-bust-out-ch…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.432.664 von GuHu1 am 29.04.11 22:37:41

Servus GuHu1,

was erwartest Du Dir von Q1, Erfüllung der Prognosen, Übertreffen oder miss....

Ich denke der Ausblick wird entscheidend sein und der ist meiner Meinung nach super....

[GuHu1]

Antwort auf Beitrag Nr.: 41.436.169 von Magnetfeldfredy am 01.05.11 21:39:39

könnte mir vorstellen das dndn leicht über den einschätzungen liegen wird, der ausbau von nj spielt bei den zahlen noch nicht mit rein....
der ausblick hängt auch noch an der entgültigen entscheidung zur kostenübernahme ab.

übrigens hab auch im sppi thread gelesen, mich wundert ein wenig das ihr euch über flintstone so aufregt, ihr solltet wissen das das eine made ist.
dndn hat bis heute mit einer reihe dieser maden zu kämpfen, falsche bzw. oberflächliche berichterstattung uvm.....
denk nur mal an die shortattacke bei dndn, da war das bei sppi kinderkacke.

trotzdem, glückwunsch!

[GuHu1]

Antwort auf Beitrag Nr.: 41.436.169 von Magnetfeldfredy am 01.05.11 21:39:39

nur noch eines zum thema maden, warum wird die kostenübername der behandlung mit abiraterone nicht durch cms überprüft, etwa weil dr. scher (leaked fda letter) maßgeblich beteiligt ist oder weil es von j&j kommt?

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.436.342 von GuHu1 am 01.05.11 23:19:18

Korruption hoch drei, die FDA ist dabei!

[GuHu1]

Press Release Source: Dendreon Corporation On Monday May 2, 2011, 4:00 pm
SEATTLE, May 2, 2011 /PRNewswire/ -- Dendreon Corporation (NasdaqNDN - News) today reported results for the first quarter ended March 31, 2011. Revenue for the quarter ended March 31, 2011 was $28.1 million compared to $21,000 for the quarter ended March 31, 2010.

The GAAP net loss for the quarter ended March 31, 2011 was $111.8 million, or $0.77 per share, compared to $125.7 million, or $0.96 per share for the quarter ended March 31, 2010 (which included a non-cash charge of $68 million loss from valuation of warrant liability). On a pro-forma basis, excluding non-cash expenses associated with depreciation and amortization, non-cash imputed interest expense, and non-cash deferred stock compensation, Dendreon’s net loss was approximately $85 million or $0.59 per share. Dendreon's total operating expenses for the quarter ended March 31, 2011 were $112.9 million compared to $57.6 million for the three months ended March 31, 2010.

As of March 31, 2011, Dendreon had approximately $779.0 million in cash, cash equivalents, and short-term and long-term investments compared to $277.3 million as of December 31, 2010.

Recent Highlights:

In addition to the $28.1 million in revenue in the first quarter, sales of PROVENGE® (sipuleucel-T) in April 2011 were approximately $15 million, reflecting increasing demand and increasing utilization of its newly approved capacity. Dendreon continues to expect revenue this year of between $350-400 million with approximately half of that anticipated in the fourth quarter.
The number of accounts infusing PROVENGE as of March 31, 2011 increased from approximately 50 to approximately 135 and we are on track to meet our goal of 225 sites infusing PROVENGE by the end of Q2.
The U.S. Food and Drug Administration (FDA) approved the expanded New Jersey manufacturing facility. The 36 additional workstations will come online in a staged approach.
Dendreon filed for FDA approval of the Los Angeles area manufacturing facility and has an action date of June 30, 2011.
Dendreon filed for FDA approval of the Atlanta facility on April 28 and expects a decision in late August or early September.
The Centers for Medicare and Medicaid Services (CMS) issued a proposed decision memo supporting the on-label coverage of PROVENGE.
Dendreon selected a contract manufacturing organization in Europe and a location for a manufacturing facility outside Frankfurt, Germany.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.441.625 von GuHu1 am 02.05.11 22:19:35

Dendreon "underperform"


Rating-Update:

Zürich (aktiencheck.de AG) - L. Kalowski, Analyst der Credit Suisse, stuft die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) in einer Ersteinschätzung mit "underperform" ein. Das Kursziel werde bei 29 USD gesehen. (02.05.2011/ac/a/u)



Anzeigen von Google Der Platow Brief

[GuHu1]

Antwort auf Beitrag Nr.: 41.444.499 von Magnetfeldfredy am 03.05.11 13:55:32

arbeitet flintstone auch für credit swiss?

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.447.117 von GuHu1 am 03.05.11 20:25:12

Wahrscheinlich!

[GuHu1]

Antwort auf Beitrag Nr.: 41.444.499 von Magnetfeldfredy am 03.05.11 13:55:32

http://www.benzinga.com/analyst-ratings/analyst-color/11/05/…

J.P. Morgan Reiterates Overweight Rating On Dendreon
By BenzingaStaffB
Benzinga Staff Writer
May 03, 2011 9:04 AM

According to J.P. Morgan, Dendreon (NASDAQ: DNDN) Overweight rating is reiterated.

J.P. Morgan said that it reiterates its OW rating on DNDN and are providing follow-up thoughts post the company's 1Q conference call. “See our earlier Quick Take for our initial thoughts on quarterly performance. Overall, DNDN continues to provide guide points that indicate favorable progress (2Q off to a good start, trajectory of adding treatment sites on track) that keep us comfortable with year-end guidance. Indeed, we are encouraged that DNDN remains on track to treat the 2,000th patient by the end of July. By our modeling, it would be difficult for Provenge not to at least meet, if not beat, 2011 guidance if new patient starts continue on the same trajectory.”

Dendreon closed yesterday at $42.81.

Read more: http://www.benzinga.com/analyst-ratings/analyst-color/11/05/…

[GuHu1]

Antwort auf Beitrag Nr.: 41.447.778 von GuHu1 am 03.05.11 22:16:22

Needham & Company Reiterates a 'Buy' on Dendreon (DNDN); Company Management Executing on Sales/Manufacturing Plans to Expand PROVENGE Use
Needham & Company reiterates a 'Buy' on Dendreon (NASDAQ: DNDN), PT $62.

Needham analyst says, "Yesterday, Dendreon reported its 1Q11 financial results and 2011 outlook. We are encouraged by management’s execution on its ..
_________

Citi research

Dendreon Corporation (DNDN)

1Q11 Results In-Line

 1Q11 Revenues In-Line — Dendreon reported 1Q revenues of $28.1M, vs. CIRA

$27.3M and consensus $29.2M. Gross margins of 35% continue to be lower than

CIRA 47% and consensus 50%; however, mgmt indicated that some of the increase in

COGS was due to start up costs related to the additional NJ capacity which was shifted

from the SG&A line to the COGS line. Mgmt indicated that they continue to expect

COGS to decrease to the 30s in 2012 when they can start realizing some operational

efficiencies. EPS for the quarter came in at ($0.77), vs. CIRA and consensus ($0.69).

Variance vs. our EPS estimate was mostly due to higher than expected GAAP interest

expense (-$0.04/sh impact), which is being recorded at a rate of 8.1% rather than the

actual cash interest expense of 2.875%. Report GAAP EPS also deviated from our

estimate due to higher COGS (-$0.02/sh impact) and higher R&D (-$0.02/sh impact).

See note for model changes.

 Expectations of 2Q — Consensus estimate for 2Q sales is currently $59M. We

believe this is doable as April sales were $15M and management indicated that "on

average" they will have 24 active work stations in NJ during 2Q, which implies capacity

of $60M for the quarter. We maintain our 2Q sales estimate of $57M.

 Expectations of 3Q & 4Q — As the "average" number of stations will be 24 in NJ, we

believe this implies that they exit 2Q with 36 work stations. Additionally, with expected

approval of the LA facility in late June, we believe the company can have "on average"

48 work stations during 3Q. This implies capacity of $120M, which is above current

consensus estimate of $102M and our previous estimate of $93M. Therefore, we are

shifting some of our forecasted sales from 4Q to 3Q as we project a smoother ramp up.

Our 3Q number now increases to $108M (+$14.4M) as our 4Q estimate decreases to

$172M (-$14.4M). Our out year revenue estimates remain unchanged.

 Conclusion(s) — We believe 2011 will be a year when the company continues to lay

the ground work for full commercialization of Provenge and do not believe the stock will

react substantially to small top-line misses/beats.

_____________


Deutsche Bank research quick take

Dendreon Alert

Q1 Quick Take - Everything is On-Track to Hit '11 Guidance.

DNDN just reported 1Q:11 earnings. Provenges sales were in-line with
consensus of $28M.
As a reminder, 1Q was capacity constrained at $9-$10/month.
Highlights from press release below. All is on-track to meet '11
sales guidance of $350-$400M in Provenge sales.

- Importantly, sales in April were $15M, which is in-line with
expectations as it represents represent 6 more workstations coming
on-line in March. Hence, Provenge demand is still causing supply
constraint.

- LA & Atlanta action dates of June 30 and late August & early
September are in-line with expectations.

- Infusing centers are on-track to have 225 on-line by end of Q2.
135 are now on-line.


The company is hosting a conference call at 4:30 PM ET. Dial-in: 877-
548-9590 (domestic) or 720-545-0037 (int'l); conference pass code:
57436485.


What to look for in the conference call?
- Additional color on April Provenge sales. More on workstations.

- Time between workstations coming online in groups of 6/month.

- Is company on-track to meet 2000 patient guidance in July & $350-
$400M Provenge '11 sales guidance.

- Progress on EU filing.

[GuHu1]

http://www.ohsu.edu/xd/about/news_events/news/2011/05-23-imm…

OHSU Knight Cancer Institute study results suggest that Provenge® could potentially prove effective in slowing down the progression of prostate cancer in its early stages

An immunotherapy for prostate cancer, which is currently used to treat men whose disease has spread to bones and is considered life threatening, shows early promise in slowing cancer progression in men whose disease has recurred following surgery, an Oregon Health & Science University Knight Cancer Institute study found.

The study results also suggest that more research is warranted to determine if the therapy, Provenge® or sipuleucel-T, could be effective in slowing the progression of the disease in its early stages.

The results of the randomized study, which were recently published in the online edition of Clinical Cancer Research, indicate that rate of rise of PSA measured in the blood was 50 percent slower in men who received the immunotherapy sipuleucel-T than those who did not. Other studies have shown that when prostate cancer returns after surgery or radiation, how rapidly PSA, a blood marker of prostate cancer, goes up correlates with the risk that the cancer will spread. It also correlates with length of life.

“One of the questions on everyone’s mind is whether sipuleucel-T could have more of an impact if it were used before the disease became life threatening. This is the first study to ask that question,” said Tomasz M. Beer, M.D., deputy director of the OHSU Knight Cancer Institute, professor of medicine in the Division of Hematology & Medical Oncology and lead author of the study. “It’s an important question for our patients because this is a drug that’s approved and available.”

Sipuleucel-T is made from a patient’s own immune cells. It is designed to stimulate a patient’s immune system to attack prostate cancer. The drug, which is manufactured by Dendreon Corp., is currently approved by the FDA to treat men with metastatic prostate cancer that is resistant to standard hormone treatment and who have minimal or no symptoms of the disease. Studies found these men live a median of four months longer when treated with the drug than those who don’t receive therapy.

But, exactly who can be helped most by the immune system boost is a subject for additional study.

“Men can live a long time with prostate cancer. If there’s a way to slow the cancer down even more at the earlier stages, the appeal is that you can change the trajectory of the disease,” Beer added. “There’s a chance of making a bigger impact.”

The study was too small to determine if the slowing in the rise of PSA will lead to delays in more serious manifestations of disease, such as spread of the cancer to bones or if it will result in longer survival. Additional larger studies are needed to answer these questions. This study, however, provides the first signal that immunotherapy may be impactful when used early after cancer recurs rather than only after the cancer is widely disseminated.

The study, titled “Randomized Trial of Autologous Cellular Immunotherapy With Sipuleucel-T in Androgen Dependent Prostate Cancer,” was funded by Dendreon. Along with Beer, the other authors are Guy T. Bernstein of the Center for Urologic Care, John M. Corman of Virginia Mason Medical Center, L. Michael Glode of the University of Colorado Health Science Center, Simon J. Hall of Mount Sinai School of Medicine, Wayne L. Poll of AKSM Clinical Research Corp., Paul F. Schellhammer of Urology of Virginia, PC/Eastern Virginia Medical School, Lori A. Jones and Yi Xu of Dendreon, Jelle W. Kylstra of Spectrum Pharmaceuticals and Mark W. Frohlich of Dendreon and PROTECT Investigators (PROvenge Treatment and Early Cancer Treatment).

# # #
About the OHSU Knight Cancer Institute

With the latest treatments, technologies, hundreds of research studies and approximately 400 clinical trials, the OHSU Knight Cancer Institute is the only National Cancer Institute-designated Cancer Center between Sacramento and Seattle— an honor earned only by the nation's top cancer centers. The honor is shared among the more than 650 doctors, nurses, scientists and staff who work together at the OHSU Knight Cancer Institute to reduce the impact of cancer. Visitwww.ohsuhealth.com/cancer or www.facebook.com/OHSUKnight for more information.
About OHSU

The Oregon Health & Science University is the state's only health and research university, and Oregon's only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government). OHSU’s size contributes to its ability to provide many services and community support activities not found anywhere else in the state. OHSU serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.
Download Related High-Resolution Image:
Download a high resolution image for Immune System Therapy Shows Promise in Slowing the Progression of Prostate Cancer in Patients with Recurrent Disease

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.551.133 von GuHu1 am 24.05.11 21:27:29

Super Recherche, wenn das hinhaut werden wir dreistellig!

[GuHu1]

http://www.minyanville.com/businessmarkets/articles/pfizer-b…

June 30
Dendreon (DNDN) should hear from the FDA on its plans to expand production of prostate cancer vaccine Provenge to a plant in Orange County, California.

[GuHu1]

Antwort auf Beitrag Nr.: 41.551.142 von Magnetfeldfredy am 24.05.11 21:29:24

Experimental Vaccine Made from Frozen Immune Cells Shows Promise for Prostate Cancer Patients

ScienceDaily (June 2, 2011) — Metastatic prostate cancer patients who received an investigational vaccine made from their own frozen immune cells lived 10 months longer than those not treated with it, according to data being presented by researchers from the Kimmel Cancer Center at Jefferson at the 2011 American Society of Clinical Oncology annual meeting in Chicago.

In an exploratory, multi-institutional analysis, researchers administered the vaccine APC8015F to a group of patients from the control arm of three randomized, Phase 3 clinical trials evaluating sipuleucel-T, a similar, FDA-approved cancer vaccine for metastatic castrate resistant prostate cancer.

APC8015F is made from immune system cells taken from a patient with prostate cancer; however, unlike sipuleucel-T, which is never frozen, APC8015F is cryopreserved at a time before the disease progressed.

Results from the analysis showed that patients treated with APC8015F had improved survival relative to the patients who were not treated in the control arm. Following disease progression, the median survival of patients treated with APC8015F was 20.0 months compared to 9.8 months for control patients.

"The study is important because it suggests that the sipuleucel-T therapy may have extended survival for a longer time than estimated in the clinical trials due to the beneficial effects of the frozen product on some men who initially received the placebo," said Leonard Gomella, M.D., Chair of Urology at Jefferson's Kimmel Cancer Center in Philadelphia. "Further, the clinical activity of the frozen-activated product is maintained."

Post-progression treatment with APC8015F, which is not FDA approved, may have extended survival of subjects, potentially reducing the magnitude of survival difference observed between sipuleucel-T and controls in randomized controlled trials.

Sipuleucel-T is FDA approved under the brand name Provenge to treat men with advanced prostate cancer that is asymptomatic or minimally symptomatic and no longer responding to hormonal therapy.

http://www.sciencedaily.com/releases/2011/06/110602162824.ht…

[GuHu1]

http://www.fiercepharma.com/story/dendreon-test-provenge-ear…

[GuHu1]

http://investor.dendreon.com/releases.cfm

FDA Approves Dendreon's Los Angeles Cancer Immunotherapy Manufacturing Facility

-FDA Approval of 36 Workstations Further Supports National Availability of First-in-Class Prostate Cancer Immunotherapy PROVENGE-

SEATTLE, June 29, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) approved its Los Angeles cancer immunotherapy manufacturing facility, allowing the company to continue to increase the availability of PROVENGE® (sipuleucel-T) across the U.S. to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

The Los Angeles facility includes 36 workstations, and Dendreon will bring these new workstations online in a staged approach. With this FDA approval and the fully approved New Jersey facility, Dendreon now has total of 84 workstations available to manufacture PROVENGE. Dendreon expects to continue to provide additional capacity through the anticipated licensure mid-year of one other manufacturing facility in the United States. In April, Dendreon filed a post-approval supplement for its third facility in Atlanta, for which there is an FDA action date of August 28, 2011.

PROVENGE is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class of drugs known as autologous cellular immunotherapies.

"As the foundation of care, PROVENGE is an important treatment option for men with metastatic castrate resistant prostate cancer," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "The FDA approval of the Los Angeles facility will enhance our ability to provide PROVENGE to the many patients across the country who may benefit from it."

In anticipation of the availability of the additional workstations, Dendreon expects to have approximately 225 active infusing sites by the end of the second quarter and approximately 500 by the end of 2011.

PROVENGE was approved based on three Phase 3 studies, including the pivotal, 512-patient Phase 3 IMPACT study, which showed that PROVENGE demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (CRPC). That trial showed PROVENGE extended median survival by 4.1 months compared to control. Overall, PROVENGE reduced the risk of death by 22.5 percent compared to the control group (HR=0.775). Results from the similarly designed Phase 3 Study D9901 in asymptomatic metastatic CRPC also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.

PROVENGE Indication and Safety

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

For more information on PROVENGE, please see the full prescribing information or call 1-877-336-3736.

About Prostate Cancer

According to the American Cancer Society, prostate cancer is the most common non-skin cancer in men in the United States and the third most common cancer worldwide. More than two million men in the United States have prostate cancer, with an estimated 240,890 new cases and approximately 33,720 men expected to die from the disease in 2011.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon's first autologous cellular immunotherapy product, PROVENGE® (sipuleucel-T), was approved by the FDA in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer. The Company is headquartered in Seattle, Washington and has manufacturing facilities in New Jersey, Georgia and California. Dendreon is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.

www.dendreon.com

This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon's business and prospects, including commercialization of PROVENGE. Information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

SOURCE Dendreon Corporation

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.721.674 von GuHu1 am 30.06.11 10:25:43

Jetzt noch eine positive CMS Entscheidung!

[HeinzBork]

Antwort auf Beitrag Nr.: 41.722.499 von Magnetfeldfredy am 30.06.11 12:22:05

Moin,
wann wird die CMS Entscheidung denn erwartet?

[GuHu1]

Antwort auf Beitrag Nr.: 41.723.232 von HeinzBork am 30.06.11 14:14:44

heute? spätestens morgen... jedenfalls wenns wie angekündigt läuft.

[GuHu1]

CMS: Final Decision

I just spoke with Dr. Leslye Fitterman at CMS and she told me that the final decision will be released between 4:01 PM and midnight. I believe that the "Proposed Decision Memo" was released at 4:15 PM. Given the positive language within the Proposed Decision Memo, I expect at least full coverage.

All the best...

http://www.investorvillage.com/mbthread.asp?mb=971&tid=10665…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.726.264 von GuHu1 am 30.06.11 21:55:32

Dendreon Wins Final Medicare Coverage Decision on Prostate Cancer Drug

By Catherine Larkin - Jun 30, 2011 10:03 PM GMT+0200
.




inShare.

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...
Dendreon Corp. (DNDN)’s prostate cancer medicine Provenge should be covered by the U.S. health plan for the elderly and disabled, regulators said, confirming a proposal from March.

The Centers for Medicare & Medicaid Services issued a final ruling today saying the $93,000 treatment is “reasonable and necessary” for men with advanced, prostate tumors resistant to hormone therapy who have minimal or no symptoms. The decision is in line with prescribing information for the drug approved in April 2010.

[GuHu1]

Medicare confirms payment for prostate cancer drug
Medicare confirms it will pay for $93,000 prostate cancer drug Provenge

On Thursday June 30, 2011, 4:19 pm
WASHINGTON (AP) -- Medicare officials are confirming that the program will pay for the prostate cancer drug Provenge, an innovative therapy that costs $93,000 and extends life about four months.

The decision from the Centers for Medicare and Medicaid repeats an earlier proposed ruling that the biotech drug from Dendreon Corp. is a "reasonable and necessary" medicine. The agency will only pay for the treatment when it is used in accordance with the instructions on the label.

The decision ensures that thousands of older men will be able to take the drug through government-backed health care coverage. With government reimbursement, analysts estimate Provenge could rack up $1 billion in sales next year.

The decision is important for Dendreon because most prostate cancer patients are 65 or older.

http://www.investorvillage.com/smbd.asp?mb=971&mn=406902&pt=…

[GuHu1]

Antwort auf Beitrag Nr.: 41.726.446 von Magnetfeldfredy am 30.06.11 22:29:22

hi fredy alter zosse.

bleibt nur eines was festzustellen ist, alles aber auch wirklich alles was das unternehmen anvisierte ist dz umgesetzt worden.
wo taxt der durchschnitt der analysten den kurs zum jahresende, um die $50 - $65 glaub ich....

[edelupolino]

Hi an die "alten" Dendreon-Fans,
ich hab die Entwicklung von unserer Aktie -besonders auch durch die Arbeit von GuHu und Fredy- aus der Ferne verfolgt und mich über die allgemeine Entwicklung bei Dndn gefreut.
Die Entwicklung auf dem Gebiet der Therapien gegen Krebs geht an viele Fronten weiter, wie auch in diesem Artikel aus der Welt zu lesen ist:

http://www.welt.de/print/die_welt/wissen/article13477016/Spr…
Beim Lesen des Artikels fiel mir unangenehm auf, dass der Autor nicht nur über die hohen Kosten der Behandlung schrieb, sondern auch vor "Nebenwirkungen, bis hin zum Schlaganfall" warnte.

Frage an euch: ist der Autor bestochen/uninformiert/ naiv oder was sonst? Als Nebenwirkungen waren doch bisher nur "leichtes Fieber" o. ä. bekannt.
Ciao Ede

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.766.998 von edelupolino am 10.07.11 16:38:52

Hi Ede,

es wird immer Kritiker gegen das "Neue" geben aber letztendlich wird sich die Immuntherapie gegen Krebs durchsetzen, was würde der Autor wohl über die Nebenwirkungen der Chemo schreiben?

Gruß

Fredy

[VaJo]

Was ist denn hier passiert? Split oder schlechte Zahlen?
Schaut ja grausam aus.

[HeinzBork]

Antwort auf Beitrag Nr.: 41.890.989 von VaJo am 04.08.11 12:26:42

http://www.xconomy.com/seattle/2011/08/03/dendreon-takes-hug…

Bin ich aber froh, den größten Teil vor dem Schuldenstreit der Amis abgestossen zu haben.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.891.215 von HeinzBork am 04.08.11 13:01:19

Brutal, so ist die Börse!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.891.557 von Magnetfeldfredy am 04.08.11 13:48:22

./. 60 %, Wahnsinn!

[VaJo]

Antwort auf Beitrag Nr.: 41.891.602 von Magnetfeldfredy am 04.08.11 13:54:13

Du hast das meiste doch schon im Hoch verkauft oder? Sei froh.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.891.936 von VaJo am 04.08.11 14:34:15

Ja, habe ich, aber hänge trotzdem noch sehr an der Story!

[brazzo007]

Wie kann denn das sein? Stand vor Provenge Zulassung war ja schon
um die 30 $, dass der Wert so gebeutelt wird, das gibts doch nicht.
Ein Kumpel von mir sagt, dass in den Staaten eine Anzeige gegen Gold läuft wegen Insiderhandel. Angeblich wusster um den Kursverlust und hat verkauft.
@ Freddy
Kannst du konkret sagen, was genau passiert ist, bzw. wie du den Kursverlauf einschätzt? Wäre sehr nett von Dir! Danke!

Gruss
Brazzo

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.892.174 von brazzo007 am 04.08.11 14:58:48

Servus,

der Ausblick von 300-400 Millionen wurde gestern zurückgenommen und die Q2 Ergebnisse haben entäuscht, das sind die Hauptpunkte in meinen Augen!
Schade, schade!

[brazzo007]

Kann jemand hier was genaueres zu dem Kursmassaker sagen?
Stand vor der Provenge Zulassung war um die 30 §. Jetzt steht der Kurs bei 13 $. Wie kann das sein. Laut nem Kumpel von mir, hat Gold ne
Anzeige wegen Insiderhandel in den USA am Hals. Er wusste angeblich, dass die Zahlen net besonders sind und hat verkauft.
@ Freddy
Könntest du etwas dazu sagen, was die genaue Ursache ist, bzw. deine Einschätzung zum Kursverlauf?
Wäre super von Dir.
Gruss
Brazzo

[brazzo007]

Sorry Doppelpost!

[edelupolino]

Antwort auf Beitrag Nr.: 41.891.961 von Magnetfeldfredy am 04.08.11 14:37:16

Tja, wie man sogar am Gold-strand von Bulgarien so sagt "shivotet e taka!"

Mit sowas MUSS man als aktionär rechnen -welche Gründe auch immer bei Dndn angeführt werden können, Krise in Amerika, die die Kranken allein lässt, Krise in Amerika, die weniger Geld in die Taschen der Privatleute spült? ...oder Vorboten des Crash, der dann alles nach unten sausen lässt (sogar Ford ist seit dem Hoch von ca 14 auf gerade 7 und 'n paar kaputte gefallen).

Wichtig: was soll man machen??????? Ich weiß natürlich NIX.
Bei wieviel sollte man nachkaufen?

Oder sind Artikel wie der vor kurzem in der Welt über Vaccine gegen Krebs (mehr Konkurrenz durch andere, die erfolgreich werden könnten durch ein weniger kompliziertes für alle Patienten problemlos injizierbares Mittel) auch Gründe für die Angst um das Wohlergehen von Dndn???

[GuHu1]

Antwort auf Beitrag Nr.: 41.894.579 von edelupolino am 04.08.11 18:39:33

ok ede hoffe das hilft.
dndn hat die erwartungen im 2 q um ca. 10% verfehlt, ja 10 %!
anstatt 55-60 mio warens nur 49,5.

grund laut mitch gold ist nicht die nachfrage ansich, sondern die vorgehensweise bei der bezahlung des behandelnden arztes. soweit ich weiß, legt dieser die 93000 aus um dann nach 2 wochen das geld von medicare zurückerstattet zu bekommen. hier fehlt laut mitch noch die sicherheit bzgl. der abwicklung, will sagen die ärzte handeln vorsichtig.

But unlike regular prescription drugs, which consumers pick up at a pharmacy, many cancer treatments are delivered in the doctor’s office. The doctor buys the drugs up front, administers them to the patient and then awaits reimbursement from Medicare or other insurance plan.

anbei ein link dazu.

http://blogs.wsj.com/health/2011/08/04/dendreon-shares-plumm…

[GuHu1]

Antwort auf Beitrag Nr.: 41.892.214 von brazzo007 am 04.08.11 15:02:33

soweit mir bekannt verklagen die amis jeden wenn sie können. (kleiner scherz)
noch mal unter vorbehalt, ich meine mitch hat seit 2007 einen festgelegten verkaufsplan unabhängig von irgendwelchen äußeren ereignissen.

[GuHu1]

Antwort auf Beitrag Nr.: 41.894.924 von GuHu1 am 04.08.11 19:30:44

wie es um den guten hans steht weiß ich nicht.....

Hans needs to beinvestigated. Hans knew a few days ago that news was bad and he sold his shares at $37.65. Check the insider transaction for DNDN. These guys need to go to jail.

http://www.cafepharma.com/boards/showthread.php?t=472884

aber mal ganz ehrlich, wie blöde muss man da sein..... speziell im fall dendreon, da hat MG in 2007 dsbzgl. schon die aufmerksamkeit auf das unternehmen gelenkt.

[GuHu1]

SEATTLE--(BUSINESS WIRE)-- Hagens Berman Sobol Shapiro, a Seattle-based investor-rights law firm today announced it is investigating Dendreon Corp. (NASDAQNDN - News) for potential violations of federal securities laws following the company’s withdrawal of its sales forecasts for its prostate cancer therapy Provenge. Dendreon previously projected that it would earn between $350 - $400 million on sales of Provenge. On news of Dendreon withdrawing earnings guidance, the stock dropped from a closing price on August 3, 2011 of $33.65 to an opening price on August 4, 2011 of $12.73.

Shares of the Seattle-based company fell more than 60 percent after the company withdrew its 2011 revenue estimates allegedly costing the company $3.2 billion in market value. Hagens Berman is investigating whether the company issued false or misleading statements to investors.

According to media reports, Provenge costs $93,000 per patient and doctors, fearing that they may not be reimbursed quickly enough, wait for payment before putting new patients on the drug. This has, according to the reports, resulted in sales below Wall Street estimates and a slowed rate of revenue growth for the company.

If you have information that would assist Hagens Berman in its investigation or are an investor who purchased Dendreon’s common stock between August 3, 2010 and the present, you are encouraged to contact attorney Peter Borkon at [e-mail] or by phone at 206-623-7292. Additional information is also available at www.hbsslaw.com/dendreon.

http://finance.yahoo.com/news/SeattleBased-Hagens-Berman-bw-…

[MrBean07]

Antwort auf Beitrag Nr.: 41.895.316 von GuHu1 am 04.08.11 20:24:59

hab ich hier schon mal vor Jahren gepostet dass das nicht funktioniert mit provenge wegen der Kostenerstattung und wurde dafür ausgelacht. Kursziel unter 0.01 EURO, ihr werdet es sehen

[edelupolino]

Antwort auf Beitrag Nr.: 41.894.884 von GuHu1 am 04.08.11 19:24:20

Hi GuHu,
danke für die Hinweise!

Da glaubt man, man hat die "Microsoft" der modernen Medizin mit ungeahnten zukünftigen Möglichkeiten und muss erfahren, dass u.a. die einfachen Zusammenhänge von Liefern/Behandeln und Bezahlen (zunächst?) alles zerplatzen lassen.

Ciao Ede

[VaJo]

Antwort auf Beitrag Nr.: 41.895.503 von MrBean07 am 04.08.11 20:50:57

Naja, wenn Dendreon scheitert haben die meisten aber riesig verdient. Wer von Anfang an dabei war und im Hoch ausgestiegen ist hat alles richtig gemacht. Von daher ist DNDN ein Erfolg.

[GuHu1]

Antwort auf Beitrag Nr.: 41.895.503 von MrBean07 am 04.08.11 20:50:57

49,5 mio anstatt der erwarteten 55 - 60 mio!
nicht funktioniert sieht etwas anders aus.

du hast behauptet das die kosten für die behandlung nicht durch medicar übernommen werden. wird es aber.

und bisher hast du immer daneben gelegen mit kostenübernahme und kursziel gelle.

[GuHu1]

Antwort auf Beitrag Nr.: 41.895.705 von VaJo am 04.08.11 21:17:41

Naja, wenn Dendreon scheitert haben die meisten aber riesig verdient
genau.
wo aber machst du das scheitern fest, doch nicht an der heutigen kursreaktion.

[future_trader]

Antwort auf Beitrag Nr.: 41.895.705 von VaJo am 04.08.11 21:17:41

Die Abstrafung ist vollkommen übertrieben. Die Aktie tendiert, wie einen Tag nach Zulassung.

Krass. Wir werden schnell einen Rebound sehen.

[GuHu1]

Antwort auf Beitrag Nr.: 41.895.830 von future_trader am 04.08.11 21:34:28

naja schau dir dow und nasdaq an, das verstärkt den absturz zusätzlich. :O

[future_trader]

Antwort auf Beitrag Nr.: 41.895.830 von future_trader am 04.08.11 21:34:28

ich hab heute gekauft ;-)

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.896.186 von future_trader am 04.08.11 22:15:00

War wahrscheinlich kein Fehler, etwas langer Atem und Du kannst nächstes Jahr belohnt werden!
Der Kurssturz heute war gleichzusetzen einer Nichtzulassung von Provenge, jedoch wird mit Provenge Geld verdient, zwar nicht soviel wie erwartet aber sollte Provenge auch für frühen Prostatakrebs zugelassen werden sind auch wieder die alten Kurse drin, kann zwar lange dauern aber denkbar!

Jedoch, wenn es mit dem Sell-Out des Gesamtmarktes so weitergeht sehen wir die 10 US Dollar erst von unten!

[mirko75]

auch wenn ich mich wiederhole,wer hoch steigt kann auch tief fallen. aktie lag 2009 bei ca. 2,10 euro.fand den anstieg der aktie bis über 30 euro für übertrieben. jetzt ist sie "immer"noch bei über 8 euro. also was solls.........

[GuHu1]

Antwort auf Beitrag Nr.: 41.896.258 von Magnetfeldfredy am 04.08.11 22:25:39

dndn muss eine lösung finden den behandelnden arzt bei dieser vorabzahlung zu entlasten.
bei 5 patienten liegt der vorschuß schon bei runden $500,000.
Also behandelt man halt nach und nach. egal ob jetziges oder frühes stadium der erkrankung.

[Elrond]

Wahnsinn ...

[VaJo]

Zitat von GuHu1: Naja, wenn Dendreon scheitert haben die meisten aber riesig verdient
genau.
wo aber machst du das scheitern fest, doch nicht an der heutigen kursreaktion.

Mit scheitern beziehe ich mich auf den wirtschaftlichen Aspekt. Was ich bei Biotechs gelernt habe ist das es eine Sache ist ein Medikament oder eine Anwendung durch die Zulassung zu bringen, aber es ist mindestens nochmal genauso Schwierig daraus auch einen wirtschaftlichen Erfolg zu machen.
Die Regel sagt, die Kosten für Forschung und Entwicklung sind gleich die Kosten für Werbung und Marketing.
Bei Provenge kommt dazu noch ein sehr großer Betrag für die Behandlung selbst.

Kranke Gesundheitssysteme, leere Kassen, Wirtschaftskrise, bankrotte Staaten, wer kann da noch zahlen?

Mir wird in dieser Hinsicht Angst und Bange vor der Zukunft. Es gibt Behandlungen die Leben retten und verlängern doch leider sind die Taschen leer, Pech gehabt...

[GuHu1]

Antwort auf Beitrag Nr.: 41.897.320 von VaJo am 05.08.11 07:49:02

http://www.minyanville.com/businessmarkets/articles/health-c…

das hatte ich vorher mit eigenen worten umschrieben:

....Dendreon's issue is more micro. Literally, urology practices don't have a big enough credit line to absorb the cost of Provenge between the time they put patients on the drug and when the Medicare subcontractors who administer Medicare get around to paying them. As a result, urologists put a couple of patients on Provenge, get paid, put a couple more on, get paid, etc. This has slowed the rate of revenue growth more than the company expected......

das gilt es zu lösen.....
und bitte nicht immer wieder suggerieren provenge sei vergleichsweise teuer...., am ende der therapien sind die kosten der "anderen produkte" auf dem gleichen level.

[GuHu1]

http://www.pharmalot.com/2011/08/provenge-reimbursement-is-a…

[GuHu1]

DNDN: Market crash or not, Dendreon (NASDAQNDN) was primed to tank anyway when news of revised guidance for 2011 hit the wires last week. The original sales guidance of $350-$400 million was canned when the high price of Provenge treatment - which can largely be attributed to logistics and manufacturing costs – cut into the willingness of Doctors to prescribe the treatment.

The haircut tore into the DNDN share price, which closed Monday under $10.50, with a total market cap of 1.5 billion. When it was all said and done – and there’s no guarantee that it is – Dendreon took a haircut by 2/3.

Not pretty.

Unless you think that the plunge was unwarranted and that Provenge sales are eventually going to kick it into high gear, as many predicted.

In terms of catalysts, everything had been going right.

The FDA was approving new manufacturing facilities for Provenge and the Centers for Medicare and Medicaid Services (CMS) decided to provide full reimbursement for the Provenge treatment. It was looking like Dendreon’s ‘Golden Age‘ would go off without a hitch.

Today, however, with the stock right around ten dollars, is it likely that DNDN is done, or does it have a good chance of recovery?

In my opinion, barring any monumental setbacks, this one has about as good a chance as you can have at bouncing back. The current prices that resulted from both the market crash and revised guidance look to be a bit overdone, and with patient demand continuing for Provenge treatment, it’s also likely that sales will grow along with manufacturing capability over the next few quarters.

In the meantime, the vultures come out of the woodworks in these situations. The law firms are already issuing press releases looking for a class action lawsuit, which I think is weak every time. The market is risky enough as it is, so your stock goes down and you cry class action?

Weak.

It’s a pretty good bet, in my opinion, that Dendreon is going to come out of this just fine. In fact, I think it’s a pretty good buy right now. Don’t forget, Provenge is still the grand daddy of cancer immunotherapy right now.

Also see: The Dendreon Bloodbath

http://marketplayground.com/2011/08/09/as-the-market-sinks-i…

[edelupolino]

Antwort auf Beitrag Nr.: 41.901.547 von GuHu1 am 05.08.11 15:46:36

zu den Kosten:
leider weiß nicht mal die "gute und seriöse" deutsche Presse (z.B. "Die Welt"), wie die Kosten von Provenge im Vergleich zu anderen (z.B. Chemotherapie) zu sehen sind.

Unsere Firma muss noch viel Aufklärungsarbeit leisten und endlich mal richtige PR - Arbeit machen.

[GuHu1]

Antwort auf Beitrag Nr.: 41.925.052 von edelupolino am 09.08.11 20:51:10

ede, eine schwalbe macht noch keinen sommer....., aber schön diese zu sehen.

[GuHu1]

Antwort auf Beitrag Nr.: 41.954.394 von GuHu1 am 15.08.11 19:23:38

Schiffman's response to my email
Just received this, and his permission to share:

Below is the response I have received just now from greg Schiffman.

----- Forwarded Message -----
From: "Schiffman, Greg" <[e-mail]>
To: "[e-mail]" <[e-mail]>
Cc: "Stueland, Katherine" <[e-mail]>
Sent: Monday, August 15, 2011 12:53 PM
Subject: RE: Please respond


Saul,

I am sorry for being so slow in responding. We have been extremely busy since our call trying to get to as many investors as we possibly can. I would expect that the next major announcement will coincide with disclosures surrounding our restructuring plan. We are working through this as quickly as possible to get the information out to both internal stakeholders as well as our investors. I appreciate the link to the forum and want to thank you for sharing your concerns. We appreciate the input of all of our shareholders and will take these thoughts under serious consideration. We appreciate your call for transparency, and that’s part of the reason we provided detail on the call that went beyond our second-quarter numbers. We intend to provide metrics that will give investors insights into our progress on a regular basis. Again, thank you for all of the support you have provided.

Regards,

Greg

From: [e-mail] [mailto:[e-mail]]
Sent: Saturday, August 13, 2011 10:44 AM
To: Schiffman, Greg
Subject: Please respond

Greg--
We met at last year's ASM. I really do own 650,000 shares. I write for Seeking Alpha--usually supporting the Dendreon story. I am a leader among shareholders. I rallied shareholders, including HealthCor, against Lilly's takeout of Icos.

Is some sort of plan announcement forthcoming "promptly"?

Please respond. (Not interested in a form response from IR, thanks.)
Saul Kerpelman

[GuHu1]

Antwort auf Beitrag Nr.: 41.954.891 von GuHu1 am 15.08.11 21:09:19

sorry quelle fehlte, bin ja nicht bean!

http://www.investorvillage.com/smbd.asp?mb=971&mn=414519&pt=…

[edelupolino]

Antwort auf Beitrag Nr.: 41.954.898 von GuHu1 am 15.08.11 21:10:35

Hi GuHu,
wollte den Artikel gerade reinstellen und freue mich, dass er hier schon gelesen wird!
Ciao Ede

[pokemon]

Antwort auf Beitrag Nr.: 41.954.898 von GuHu1 am 15.08.11 21:10:35

cooler anstieg gestern !

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 41.956.036 von pokemon am 16.08.11 08:13:05

Stimmt, aber nur ein kleiner Hüpfer nach dem brutalen Absturz von US Dollar 35!
Vielleicht wieder eine Einstiegschance bei meinem ehemaligen Tenbagger?
Jedoch muß erst wieder Vertrauen mit guten Quartalszahlen aufgebaut werden!

[pokemon]

Antwort auf Beitrag Nr.: 41.956.096 von Magnetfeldfredy am 16.08.11 08:27:08

verstanden, danke!
habe molos natürlich, meine tenbagger für 2012

[GuHu1]

Antwort auf Beitrag Nr.: 41.956.096 von Magnetfeldfredy am 16.08.11 08:27:08

http://www.investorvillage.com/smbd.asp?mb=971&mn=414729&pt=…

Deutsche Bank...Clarity on restructuring will be announced shortly- NEXT catalyst
We spoke with Dendreon Management. The company said with potentially the next 4 weeks they will outline in depth their restructuring plan for Dendreon.

**Specifically- the company is making precise cuts to their manufacturing business and will discuss in depth how investors should think about this.

**Core spending on sales will likely not change, if anything go up slightly. R&D spending will remain.

**Roughly $400M is the break-even point for Provenge sales profitability.

What we want to know: more color on plans in place to address reimbursement, and marketing plan (we think this is a BIG issue).

We think this restructuring announcedment will be the NEXT catalyst, give some investors (esp value) comfort owning the name.

[GuHu1]

nur mal so......

http://cancerprnews.com/cancer_articles/2011/07/prostate-can…

[GuHu1]

Dendreon Corporation CEO Mitchell H. Gold to Receive 2011 Grace Award from Cancer Research Institute
Released: 8/17/2011 2:00 PM EDT
Source: Cancer Research Institute

CRI to Honor Gold’s Leadership in Advancing First FDA-Approved Therapeutic Cancer Vaccine

Newswise — The Cancer Research Institute, Inc. (CRI), a U.S. nonprofit organization established in 1953 to advance the science of tumor immunology and drive the discovery of new cancer immunotherapies, announced today that Mitchell H. Gold, M.D., president and chief executive officer of the Seattle biotech company Dendreon Corporation (NASDAQ: DNDN), will receive the 2011 Oliver R. Grace Award for Distinguished Service in Advancing Cancer Research. This annual award recognizes the contributions of exceptionally dedicated individuals whose leadership has had significant impact on medical research, patient care, or public education.

“The April 2010 FDA approval of sipuleucel-T active cellular immunotherapy, or Provenge®, to treat prostate cancer patients with advanced disease marked a historic milestone for tumor immunotherapy,” says Jill O’Donnell-Tormey, Ph.D., chief executive officer and director of scientific affairs at CRI. “As the first therapeutic cancer vaccine to receive FDA approval, sipuleucel-T not only represents a significant advance in bringing a new class of immune system-based treatments to cancer patients, but also has helped provide a developmental roadmap for other promising cancer immunotherapies now in clinical trials that we expect will lead to more approvals in the near future.”

As president and CEO of Dendreon Corporation, Dr. Gold provided critical leadership and vision to the company as it sought to bring sipuleucel-T to market. Despite setbacks, the company succeeded where others had failed before, clearing key regulatory hurdles and surviving unanticipated delays in the approval process. The company also captured the support of patient advocates and the prostate cancer patient community, many of whom looked to Dendreon for hope in the face of few to no other treatment options.

“I am humbled by this honor, and am committed to continuing to change the way that cancer is treated,” says Dr. Gold. “The fight against cancer is a personal one, and it’s one that I know we can win, through advancements such as cancer immunotherapy. Now is the time that we must double down on our efforts to finish what we started 40 years ago in the war against cancer.”

Dr. Gold will receive the Grace Award at an evening gala hosted by the Cancer Research Institute on October 3, 2011, at 583 Park Avenue in New York City.

http://www.newswise.com/articles/dendreon-corporation-ceo-mi…

[GuHu1]

http://seekingalpha.com/article/288517-how-undervalued-dendr…

[GuHu1]

http://www.biocentury.com/biotech-pharma-news/coverstory/201…

[GuHu1]

http://www.businesswire.com/news/home/20110826005768/en/FDA-…

FDA Approves Dendreon's Atlanta Cancer Immunotherapy Manufacturing Facility

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.009.476 von GuHu1 am 26.08.11 21:39:49

.....und fast keine Reaktion, arme Dendreon!

[GuHu1]

Antwort auf Beitrag Nr.: 42.009.523 von Magnetfeldfredy am 26.08.11 21:50:09

meldung kam kurz vor börsenschluss.
sei es drum, wir werden kursreaktionen erst sehen wenn das "demand" problem gelöst ist, z.b. J code.


If DNDN won't give you some GOOD news...I WILL!!

1st new "floodgate" opened:

Oncologist colleague/friend called me this evening.

>Infused 1st patient with Provenge
>Went very smoothly
>NO adverse side effects

**THREE new patients scheduled for infusions ober the next few weeks

**Sudden INCREASE in referrals from local Urology group!!

**MULTIPLE patients from "backlog" list being "processed" for therapy

Also......

He was COMPLETELY UNaware of the events of the past three weeks.
"Too busy seeing and treating men with PCa."
His whole group VERY excited to have PV now available for thier patients.

Is NOT a shareholder.

Local DNDN rep is personable, knowledgeable and accessible.

Re-imbursement is a NON-ISSUE for his Oncology group.
and Provenge.
He sees nothing but future success for DNDN / Provenge.

I was struck by the complete DISconnect between the mainstream media/Wall Street negativity and this guy's ENTHUSIASM for being now able to infuse Provenge to his numerous patients.

Amazing, really.....

Maybe thibgs aren't as bad as they appear............

Good luck!

Chipster

PS Will keep you all posted on th progress of this particular group/infusion site.

http://www.investorvillage.com/smbd.asp?mb=971&mn=416261&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.010.417 von GuHu1 am 27.08.11 11:49:34

Servus GuHu1,

wann denkst Du bekommt Dendreon den J-Code?

[GuHu1]

Antwort auf Beitrag Nr.: 42.010.870 von Magnetfeldfredy am 27.08.11 15:26:42

hi fredy, juckt der finger wieder?

code Q = gilt ab august 2012, bezahlung des arztes nach 30 tagen.
code J = soll ab 2012 gelten, bezahlung des arztes nach 14 tagen.

ich persönlich denke anfang 2012 gibts den code J.
solange das nicht offiziell bestätigt wurde ist das spekulation, klar.

das alles ist aber unter vorbehalt, wer andere infos hat bitte einstellen.

[GuHu1]

will hier nicht weiter rumnerven und halte mich in nächster zeit wieder zurück.
nur noch einmal ein überblick der situation speziell zu provenge.
kann leider keinen link einstellen, geht halt nicht.....

I believe I owe you an apology for being mean initially. So I am sorry and I'm glad we are conversing now. Furthermore, I hope you read this in its entirety and enjoy the complexity of the situation. I hope the truth will be disseminated, and that you will be one of the brave souls to help spread the word and correct the misconception. Sections 1 and 2 are background and informative. The most important section is #3. Clinical Trials.

1. Math background:

First we have to acknowledge that the FDA and Dendreon use the word "median" and not "average" in documents and press releases.

http://en.wikipedia.org/wiki/Median defines median as "a median is described as the numerical value separating the higher half of a sample, a population, or a probability distribution, from the lower half. The median of a finite list of numbers can be found by arranging all the observations from lowest value to highest value and picking the middle one... At most, half the population have values less than the median, and, at most, half have values greater than the median."

If we have a range of numbers, say [1,4,7,8,21,25,30,33,39], then:

The median is the number in the middle. In this case it is 21. So there are 4 numbers right of 21 and 4 numbers to the left of 21. 21 is in the middle...
The average on the other hand is all the numbers added together and divided by how many numbers are in the list. The average is: 18.66

2. What is Provenge and how does it work:

Reference: http://www.provenge.com/advanced-prostate-cancer-therapy.asp…

"PROVENGE is the only FDA-approved treatment that uses the body's own immune system to fight the disease. This type of treatment is called autologous cellular immunotherapy."

Definitions:

autologous: Comes from you.
cellular: Made from your cells
immunotherapy: Treatment that helps your immune system fight cancer

The patient donates blood, the white blood cells are sent to a lab where they are trained to detect, fight, and kill prostate cancer. The patient has to repeat this process three times, and every time, the immune system becomes stronger and more knowledgeable about how to fight and destroy cancer cells. In fact, after 3 infusions, the body starts to train itself and the immune system starts to multiply itself against prostate cancer. For instance the Kaplan Meier survival chart I attached says that the survival advantage of Provenge at 1, 2, and 3 years is 12%, 27%, and 38% greater than the control group, an increasing trend indicative of Provenge ramping up the immune system and the treatment effect getting better with time. The immune system gets stronger over time as the knowledgeable white blood cells begin to multiply on their own autonomously.

3. Clinical Trials:

*** Important stuff starts here ***

So when we read that statements such as:

"The trial showed PROVENGE extended median survival by 4.1 months compared to control." (From press release August 26th, forwarded below)
"The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment [those in the control group]." (your quote from the FDA website, with my clarification)
Extends median survival beyond 2 years - 25.8 months compared with 21.7 months for patients in the control group (P=0.032) (taken from http://www.provenge.com/hcp/survival-rate.aspx)
In the Phase 3 IMPACT Trial, PROVENGE reduced the risk of death by 22.5% for patients in the PROVENGE group, compared with those in the control group (HR=0.775; [95% CI: 0.614, 0.979]) (taken from http://www.provenge.com/hcp/survival-rate.aspx)

These statements mean that it took 21.7 months for half the men in the control group to die, and 25.8 months for half the men in the Provenge arm to die. That is where the "4.1 month median survival advantage" comes from. But remember, at this point in time, half the population is still alive and lived additional months, and years. It tells nothing about those who lived longer than 25.8 months, which can't be calculated, because when they stopped following the patients in the trials, there were still men alive. Men lived years longer after taking Provenge.

The last bullet point says that on any given day a man on Provenge has 22.5% less chance of dying than one who was in the control group. Or inversely, that a man on Provenge has 29% (1/.775) greater chance of surviving to see tomorrow than one who was in the control group.

But let's go a little bit further and investigate some more. You have to ask yourself, what are they comparing? What is the control group, to have a better understanding. Are they comparing patients who received Provenge with patients who did not receive Provenge? The answer is no. They are comparing patients who received Provenge initially against a group of people who did not receive Provenge until their disease started to progress at a later time. The company decided for compassion, that they would not allow these men to die for drug testing purposes, and thus provided it to them at a later point in time. This is called "compassionate use" and occurs on a company by company basis during drug trials. Therefore, it is not a trial with a 100% true placebo where one group just gets a sugar pill. Dendreon decided that It was unethical and they attempted to save and help everyone in the trial to receive the treatment. With this in mind, it means that Provenge was competing against itself and not a placebo. Provenge was competing against Frovenge (Frozen Provenge made from a control patient's blood in the control arm which was saved (cryopreserved) and given to them at a later point in time). Amazing!

Attached is a chart (trial_design.gif) from the health care provider section of Provenge.com, which explains that the control group was given Provenge after progression. The page http://www.provenge.com/hcp/impact-trial.aspx (where the cart is taken from), continues to say that:

Patients in the control group had the option to enter a Phase 2, open-label protocol to receive an autologous immunotherapy made from cells that were cryopreserved at the time of placebo generation

Treatment—An autologous immunotherapy made from cells that were cryopreserved at the time of control generation
Participation—63.7% of patients in the control group entered the Phase 2 protocol (63.7% of the men still alive and willing to participate in the trial and given an okay from their doctors to continue in the trial and receive Provenge)

Now quoting Wikipedia again, which does mention references at the bottom of the page, http://en.wikipedia.org/wiki/Sipuleucel-T

"Placebo patients in all three trials were allowed to cross over after disease progression to take a version of Sipuleucel-T made from their frozen blood saved on trial entry (APC8015F). The publication of the IMPACT study[3] observed that the cross-over patients had an estimated median survival time of 23.8 months comparing to 11.6 months for those patients who never received Sipuleucel-T in any form. However, this observation was retrospective so a prospective test would be required before the implied benefit of frozen Sipuleucel-T could be confirmed"

What this means is that half (median) of the patients in the control group that received Frozen Provenge lived 23.8 months longer than the small number of patients who elected to not receive Frozen Provenge at all after their disease progressed. Reference the second bullet point above where 63.7% of patients in the control group crossed over to receive Frozen Provenge. There was a small number of men who elected not to cross over and therefore never received Frovenge or Provenge are the ones who lived a median of 11.6 months. You can consider this small group to be the trial's "pure placebo", i.e. not cross over to frozen provenge after progression.

From this we can infer that the patients who were in the Provenge arm from the beginning (25.8 median survival) lived 14.2 months longer than patients refused to receive Frovenge (Frozen Provenge). The number 14.2 comes from, 25.8 minus 11.6 = 14.2.

If you want to delve down further, ask yourself, did patients who received Frozen Provenge benefit from the drug in the Frozen form? After they unfroze the drug and gave it to the patients, was it an active agent that benefited them? Remember, Frovenge is the same drug, but given at a later point in time...

Unfortunately, the company is bound by the FDA on what and how it can publish the data. They are not allowed to provide a layman interpretation of the data which is what is causing this plethora of confusion. They use to have a chart that showed a 38% increased chance of survival at 3 years if given Provenge compared to control (chart attached and can be found here http://www.provenge.com/hcp/images/expanded/kaplan-meier_sur… but they have since taken it down. In fact, most men who received Provenge from the trials died of other complications rather than prostate cancer. Remember, these are senior old men who have other health issues and who have late state aggressive prostate cancer which failed to be controlled by hormone treatment and has metastasized (spread from one organ to another). Having these men overcome cancer and die of other illnesses is revolutionary. In fact, as I said in another email, Provenge shows the best overall survival of any cancer drug in history. Hopefully Provenge will be successful so that the company can further expand their pipeline to other cancers, including breast cancer. Which is why it is important that the truth is disseminated and so that doctors will not misinform their patients that they will only live 4 months longer.

4. Conclusion:

I hope I have convinced you about median and average as being two completely different things.
Patient's who have received Provenge get stronger over time as the immune system ramps up begins to autonomously multiply and destroy prostate cancer cells inhibiting their growth.
I hope I have convinced you that Provenge does not extend survival by just 4 months and that the FDA trials were done against a frozen version of Provenge, not a placebo.
63.7% of patients in the control group entered the Phase 2 protocol - http://www.provenge.com/hcp/impact-trial.aspx
That many men lived longer than any other cancer treatments available for late stage asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) advanced prostate cancer.
Survival advantage of Provenge at 1, 2, and 3 years is 12%, 27%, and 38% greater than the control group.
On any given day a man on Provenge has 22.5% less chance of dying than one who was in the control group. Or inversely, that a man on Provenge has 29% (1/.775) greater chance of surviving to see tomorrow than one who was in the control group.
The trials were conducted on the sickest of patients and showed remarkable overall survival.
Men died of complications other than Prostate cancer since they outlived and conquered their prostate cancer.
Provenge has the best overall survival in the history of medications fighting against cancer.
Provenge is truly revolutionary as it the only FDA-approved treatment that uses the body's own immune system to fight the disease. This type of treatment is called autologous cellular immunotherapy.
Is it the first cancer treatment vaccine approved by the FDA
Bottom of: http://www.provenge.com/advanced-prostate-cancer-therapy.asp…
" it may be considered a cancer treatment vaccine."
Cancer treatment vaccines, on the other hand, are used to stimulate the body's own immune cells to attack cancer cells that already exist in the body.
Just imagine if patients were allowed to take Provenge before they were in late stage prostate cancer. Dendreon is already doing trials to expand Provenge's label.

Did I mention the side affects are just Flu like symptoms? How amazing is that? Imagine if all cancer vaccines had Flu like symptoms. No more chemotherapy.

Now imagine what competitors would do, to give Provenge a bad wrap and control their monopoly.

I hope you have found this information useful and will consider writing another article about Provenge. I also urge you to contact the company, and speak with them directly to better understand the trials and statistics involved. It is a very complex trial (as all are) to understand, and can be mind boggling, but it give it some time to sink in.

Thank You SO SO Very much,
A

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.011.638 von GuHu1 am 27.08.11 21:20:56

Danke, ja er juckt wieder!

[Ville7]

Auch hier bei DNDN galt schmerzlich: Never fall in love with stock. Die Realität ist meist viel härter als die Phantasie und Euphorie.

[MrBean07]

Antwort auf Beitrag Nr.: 42.011.683 von GuHu1 am 27.08.11 21:51:20

Fand die Daten noch nie überzeugend. Man weiß doch wie solche Studien gemacht werden wenn es um die Wurst geht. Wichtig ist die Auswahl der Patienten und deren Zuordnung in die Gruppen. Insgesamt ist die Patientenzahl ohnehin zu gering gewesen. 21 Mio Umsatz ohne Wachstum zeigen ja dass, dass die eventuell zu gewinnenden 4,1 Monate teuer verlängerter Überlebenskampf in der Klinik nicht überzeugen.

[Fruehrentner]

Was man bei neu eingeführten Wirkstoffen/Medikamenten auch nie vergessen darf:

Es beginnt dann die klinische Phase IV, wo weitere Daten über Wirksamkeit und vor allem Nebenwirkungen gesammlet werden. Hier kann es wie so oft in den letzten Jahren noch so manch böse Überaschung geben (s. Lipobay von Bayer etc.).

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.063.511 von MrBean07 am 09.09.11 08:46:30

Provenge ist in der Indikation Prostatakrebs mit Metastasen im Knochen der Konkkurenz überlegen, in allen Belangen und ein grßer Gewinn für die Patienten!
Der Roll-Out hat erst begonnen, Erbitrux hat auch langsam begonnen und dann.........

[GuHu1]

Antwort auf Beitrag Nr.: 42.063.511 von MrBean07 am 09.09.11 08:46:30

vergiss was du geschrieben hast.....

das sagt die John Hopkins University zum thema provenge, artikel vom 08.09.11:

http://www.johnshopkinshealthalerts.com/alerts/prostate_diso…

The U.S. Food and Drug Administration's (FDA's) approval of sipuleucel-T (Provenge) -- the first vaccine for the treatment of cancer -- marks an important milestone in the war against prostate cancer. Provenge doesn't prevent prostate cancer (in the sense that most traditional vaccines prevent disease), or cure it or even slow its spread. But it does prolong life in some men with advanced prostate cancer. The extra time, slightly more than four months, is modest, at best, but important because it is proof that a cancer vaccine to boost the immune system can prolong life, suggesting that future vaccines might be even better.

Unlike traditional vaccines, this type of vaccine, also called cancer immunotherapy, is designed to help a person's immune system recognize its own cancerous cells as foreign. Once the cancer cells are perceived as intruders, the person's immune system can mount an attack against them. However, this is particularly challenging with prostate cancer because a man typically has had the disease for several years before it metastasizes. During that period, his immune system has seen the cancer but has grown complacent.

Provenge is approved only for men with advanced prostate cancer who have not responded to other treatments like hormonal therapy and are experiencing few or no symptoms. While the FDA's approval of Provenge is a victory, it is not the end of the fight. Researchers are already studying a number of ways to improve the vaccine's effectiveness.

For example, investigators at Johns Hopkins have found that combining Provenge with androgen deprivation therapy increases the chances of stopping prostate cancer early on. Similarly, investigators have found that combining Provenge with radiation therapy also appears to have a synergistic effect.

Provenge is also being tested in several other clinical trials, including a phase 3 study called Provenge Treatment and Early Cancer Treatment (PROTECT). This study involves men with early-stage, nonmetastatic prostate cancer. Many experts believe that immunotherapy may be most effective in men who have earlier-stage disease.

Newer vaccines also are under development. In one phase 2 study, a vaccine called Prostvac prolonged median survival by 8.5 months. However, like Provenge, Prostvac failed to improve time to disease progression. If Prostvac makes it through the FDA approval process, it promises to be cheaper than Provenge, since it does not have to be customized for each patient and will be available "off the shelf."

[GuHu1]

Antwort auf Beitrag Nr.: 42.063.213 von Ville7 am 09.09.11 07:00:23

da hast du recht.....

http://www.investorvillage.com/smbd.asp?mb=971&mn=417893&pt=…

Deutsche Bank

Dendreon Alert

BUY

Target $20

**DNDN hosted a clear call addressing mostly expense mgmt, reimbursement progress & COO departure. We believe this call was an important event for long-term/value oriented investors evaluating the story. DNDN clearly laid out cash flow breakeven strategy. Based on our analysis, the plan seems achievable.

**Stock likely range-bound until proof of inflection.

**Although expense restructuring plan & mgmt execution of call were encouraging, we believe that the stock strongly remains a show-me story until we see Q/Q Provenge sales growth. Sales in Aug are modestly up, but we believe that investors will want to see at least two more Q's of Provenge sales before becoming comfortable in a turnaround. DNDN reiterates minimal Q/Q growth & will not provide color on '12 sales. This shows need for more proof.

**Cash flow breakeven is possible in '13 - Capital raise unlikely.

**DNDN announced it will take $500M Provenge sales to achieve cash flow breakeven via $120M in annual savings from COGS & SG&A. This roughly assumes 55% gross margin (-$225M COGS), -$100M in R&D expense & -$275M in SG&A. To achieve neutral cash flow, $100M in non-cash fees is added back. Importantly, this will allow DNDN to avoid a capital raise.

**Some progress on reimbursement but never thought that was the main problem. Marketing is key.

**We were encouraged by DNDN's comments around improvement in educating docs around Q code & measurable improvement in avg time to reimbursement (now 30 days). However, we maintain that urologists comfort around reimbursement was the main issue but DNDN did not appropriately market to urologists. For us to gain comfort, we want to see that urologists are comfortable not only w/ reimbursement but treating pts. Education remains key to potential inflection.

**DNDN will not build a plant in the EU. Lowers CapEx & cash burn.

**We understand that the likely EU strategy is not a partnership but instead DNDN would pay a fee (under COGS) to a contract manufacturer. As a result, gross margins will not be as good as US but DNDN will save $65-$70M on CapEx associated w/ a plant. Progess in the EU could be a catalyst.

**Maintain Buy - $20 TP.

**We maintain our Buy as we believe that there is real demand that just needs to be unlocked w/ better marketing strategies. We remind that 15k pts are treated w/ chemo which has worse side effects. We believe Provenge has better survival & safety profile that will drive at least 5k pts to use.

[edelupolino]

@GuHu und Fredy
das sind nachrichten, die gefallen können; in einem besseren Börsenumfeld und wenn die Ärzte noch mehr Ahnung von Provenge bekommen (und die finanzielle Seite besser geregelt wird), könnte Dndn wieder verlorenen Glanz aufholen.
Ciao Ede

[GuHu1]

http://seekingalpha.com/article/292713-dendreon-righting-the…

[MrBean07]

Antwort auf Beitrag Nr.: 42.067.588 von GuHu1 am 09.09.11 19:11:45

Vorsicht vor diesen Seiten (seekingalpha, motley fool uva.). Im Angelsächsischen wird noch viel stärker manipuliert als sonst irgenwo.

Provenge ist weniger rosig als viele hier glauben. Der Kurs spricht eine eindeutige Sprache. Fachdiskussionen bringen beim hiesigen Publikum nichts. Dendreon strong sell. Die Börse hat immmer recht. Punkt.

[GuHu1]

Antwort auf Beitrag Nr.: 42.068.185 von MrBean07 am 09.09.11 21:16:43

welche seite meinst du, die der hopkins university, den der deutschen bank oder den kommentar von saulk auf seeking alpha?

die börse hat immer recht nun gut, dndn heute + 5%, nasdaq + dow um - 2,5% . lassen wir das mal so stehen.

eines noch zum wachstum.
rechne mal den umsatz auf dez. 2012 hoch wenn du 12% wachstum von monat zu monat ansetzt. das wachstum von juli 2011 auf august 2011 (q code gilt ab august) beträgt 16%.
500 mio sind break even.

[GuHu1]

Antwort auf Beitrag Nr.: 42.068.185 von MrBean07 am 09.09.11 21:16:43

eines noch, jemand der als kursziel $ 0,01 ausgibt für ein unternehmen

- mit einem FDA zugelassenem medikament
- mit dem besten überlebensvorteil + nebenwirkungsprofil für die zugelassene indikation
- kosten werden von den us krankenversicherung komplett zu übernommen
- wachstum der infusion center (dz. 656, 420 aktiv)
- 3 FDA zugelassenen produktionstätten
- wachstum, zwar nicht so rasant wie vorhergesagt, aber wenn es so weitergeht nicht schlecht (von 07 auf 08 = 16%).
- über 600 mille auf der bank
- weitere laufende studien

ja so einem würde man nie im leben manipulation nachsagen.

[Magnetfeldfredy]

!

Dieser Beitrag wurde von HotMod moderiert. Grund: Beleidigung

[GuHu1]

Antwort auf Beitrag Nr.: 42.068.660 von Magnetfeldfredy am 09.09.11 23:03:55

http://viewer.e-digitaledition.com/issue/40336

[GuHu1]

Antwort auf Beitrag Nr.: 42.072.341 von GuHu1 am 11.09.11 21:27:16

http://viewer.e-digitaledition.com/issue/40336

[GuHu1]

http://www.cancercenter.com/prostate-cancer/immunotherapy.cf…

[MrBean07]

!

Dieser Beitrag wurde von HotMod moderiert. Grund: Spam, Werbung

[Magnetfeldfredy]

!

Dieser Beitrag wurde von HotMod moderiert. Grund: Beleidigung

[MrBean07]

!

Dieser Beitrag wurde von HotMod moderiert. Grund: Spam, Werbung

[Magnetfeldfredy]

!

Dieser Beitrag wurde von HotMod moderiert. Grund: Beleidigung

[edelupolino]

Antwort auf Beitrag Nr.: 42.088.058 von GuHu1 am 14.09.11 19:52:30

Hi GuHu,
hier ein interessanter Artikel:

Is Dendreon a Turnaround Candidate?
http://www.fool.com/investing/high-growth/2011/09/12/is-dend…

Es wird darin auf Konkurrenz von J+J und Sanofi verwiesen.
Wie ist deine Meinung dazu?

Ciao Ede

[GuHu1]

anbei eine graphische darstellung zu welchem zeitpunkt provenge eingesetzt wird (laut label).
ist aus der letzten präsentation.... "Rodman & Renshaw Annual Global Investment Conference"



hoffe das klappt?

[GuHu1]

Antwort auf Beitrag Nr.: 42.088.967 von edelupolino am 14.09.11 22:35:06

zwei doofe ein gedanke
nie den überlebensvorteil und das sehr gute nebenwikungsprofil von provenge vergessen.

[edelupolino]

Antwort auf Beitrag Nr.: 42.088.984 von GuHu1 am 14.09.11 22:37:40

Hi GuHu,
ja, die Graphik ist sehr klar. Ich danke dir.
Persönlich würde ich -wegen der kaum vorhandenen Nebenwirkungen, die du auch wieder erwähnt hast-, Provenge vorziehen.
Aus Vorsicht werd ich bei evtl Aktienkäufen zwar nicht alles auf dndn setzen; aber die Gewinnzone scheint mir erreichbar zu sein, was wieder einige Käufer anlocken wird: das Fazit scheint zu sein, dass sich ein Engagement lohnt.
Ciao Ede

PS: wenn die anderen Medikamente ohne (große) Nebenwirkungen sind, sieht's natürlich nicht so gut aus; abwarten ist wohl angesagt.

[edelupolino]

Antwort auf Beitrag Nr.: 42.088.997 von GuHu1 am 14.09.11 22:40:59

...lese gerade noch über Zytiga:
"Für Patienten, die die Standardtherapieformen wie beispielsweise Chemotherapie erschöpft haben, bietet Abirateronacetat eine neue, gut verträgliche Möglichkeit zur Behandlung dieser zerstörerischen Krankheit", erklärte Professor Johann S. de Bono, MD, FRCP, MSc, PhD vom The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, einer der führenden Forscher der klinischen Phase 3-Studie. "In Europa ist Prostatakrebs die dritthäufigste Todesursache; daher müssen unbedingt neue Behandlungsmöglichkeiten wie Abirateronacetat entwickelt werden."

Insgesamt war die Compliance bei der Behandlung mit Abirateronacetat hoch, die Nebenwirkungen waren trotz des hohen Alters und der Gebrechlichkeit der Studienteilnehmer einfach therapierbar und reversibel.[4] Die häufigsten Nebenwirkungen von Abirateronacetat sind periphere Ödeme, Hypokalämie, Bluthochdruck und Infektionen der Harnwege.[1]
aus: http://www.presseportal.ch/de/pm/100000676/100703471/zytiga-…

Vor der Einnahme von Z soll erst per Chemo therapiert werden?? Die Chemo will ich mir aber im Fall der Fälle 100%-ig ersparen!

[GuHu1]

http://www.usoncology.com/network/NewsRoom/NewsReleases?p_mo…

[GuHu1]

http://news.yahoo.com/immune-system-discoveries-earn-nobel-m…

[GuHu1]

http://www.spiegel.de/wissenschaft/medizin/0,1518,789668,00.…

.......Der verstorbene Ralph Steinman, der das Labor für zelluläre Physiologie und Immunologie an der Rockefeller University in New York leitete, sollte die Hälfte des Preisgelds von rund 1,1 Millionen Euro erhalten. 1973 hatte er eine Gruppe von wichtigen Zellen im Immunsystem entdeckt: die sogenannten dentritischen Zellen. Diese können die Erkennungsstrukturen von körperfremden Zellen, die Antigene, präsentieren und so ein größeres Arsenal an Waffen des erworbenen Abwehrsystems aktivieren. Vor allem die T-Lymphozyten schlagen dann zu: T-Killerzellen zerstören direkt fremde Zellen, T-Helferzellen schütten Botenstoffe aus, die wiederum Entzündungszellen anlocken und regulatorische T-Zellen sorgen dafür, dass körpereigene Strukturen nicht zu stark angegriffen werden.

Die dendritischen Zellen sollten auch Steinman das Leben retten. Dass er vier Jahre gegen den Bauchspeicheldrüsenkrebs kämpfte, werten einige Forscher so, dass seine selbst entwickelte Immuntherapie ihm geholfen hat. Der aggressive Tumor führt unbehandelt meist innerhalb von kurzer Zeit zum Tod. Doch auch ein ganzes Arsenal an Abwehrzellen konnte den Forscher am Ende nicht retten. Für die Familie könnte die Ehrung ein schwacher Trost sein: "Wir sind alle so berührt, dass die vieljährige harte Arbeit meines Vaters für den Nobelpreis ausgewählt wurde", sagte Steinmans Tochter Alexis. "Er wäre zutiefst geehrt."

[edelupolino]

Antwort auf Beitrag Nr.: 42.164.890 von GuHu1 am 03.10.11 23:31:53

Hi GuHu,
dass er mit Hilfe (auch) seiner Erkenntnisse SO LANGE mit Bauchspeicheldrüsenkrebs überlebte, muss jeden, der diese Form des Krebses in seiner Familie/Bekanntenkreis kennen lernen "durfte" extremst überraschen. Trotz Behandlung mit Chemo sterben die Patienten i.d.R. nach kurzer Zeit.

Der Kursverlust wird ja in IV stark diskutiert: mal sehen, wie tief es noch sein wird; viele schieben die Schuld auf Gold oder auf Probleme, Provenge professionell zu vermarkten.
Ciao Ede

PS: wenn ich das Wort "dendritisch" höre, möchte ich gern den kleinen Film von Dndn noch mal sehen, der die Wirkungsweise von Provenge verdeutlichte. Hast du zufällig einen Link dazu?

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.166.918 von edelupolino am 04.10.11 14:02:36

Servus Ede,

bin auch wieder dabei mit 1000 Stück, die Welt wird nicht untergehen, leider wird es immer Prostatakrebs geben und Dendreon hat die Zulassung für die erste nebenwirkunsarme Immunkrebstherapie, wird erstattet......
Kurse wie vor der Zulassung.....
Kann mir Kurse von 20 US Dollar in einem Zeitraum von 6 Monaten vorstellen!

[GuHu1]

Antwort auf Beitrag Nr.: 42.166.918 von edelupolino am 04.10.11 14:02:36

hi ede,
meinst du das auf provenge.com

http://www.provenge.com/how-provenge-works.aspx

[GuHu1]

http://www.bloomberg.com/news/2011-10-03/nobel-laureate-ralp…

...Audience Scoffed

“I remember a meeting in Paris, an international meeting where Ralph had me give the talk,” he said. The response from the audience “was abusive.”

The problem was that other scientists couldn’t immediately reproduce the research, Nussenzweig said.

“There was a terrific amount of skepticism in the early days that these dendritic cells were anything other than an artifactual variant of another cell type,” said Mellman, who described Steinman as his mentor in the late 1970s when they were at Rockefeller. “Because there was this skepticism, Ralph didn’t advance in a fashion that was anywhere near the rate of advancement had he simply gone with the flow.”

Steinman’s ability to purify the cells wasn’t replicated until a decade later, when researchers found ways to isolate them in larger numbers using newer techniques.

“It took a long time,” Nussenzweig said. “But he just always knew he was right.”

...Laying a Foundation

The work of this year’s winners has provided the basis for research into medicines for cancer, inflammatory diseases and infections, the Nobel committee said on its website.

“These are kind of the master cells in starting immune response,” James Allison, an immunologist at Memorial Sloan- Kettering Cancer Center, said of Steinman’s discovery in a telephone interview.

Steinman’s research is the basis for the prostate-cancer therapy Provenge, developed by Seattle-based Dendreon Corp. (DNDN), which last year received regulatory approval as the first medicine to train the body’s immune system to attack cancer cells like a virus.

“While he wasn’t directly involved in the founding of Dendreon Corporation, it was his science which our scientific founder, Ed Engleman, was working with as he was looking to find these type of cells,” said David Urdal, Dendreon’s chief scientific officer. “Ralph is really one of the giants in immunology.”

[edelupolino]

Antwort auf Beitrag Nr.: 42.168.913 von GuHu1 am 04.10.11 19:30:58

@ GuHu: genau das meine ich! Vielen Dank; werde den Link sofort speichern!

@ Fredy und GuHu: bin immer wieder für Provenge und Dndn und kaufe (vorsichtig) weiter.
Ciao, ihr zwei!
Ede

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.169.818 von edelupolino am 04.10.11 21:58:01

Servus Ede,

Provenge ist ein Erfolg, aber das Vertrauen muß wieder reinkommen, wird nur durch stetig steigende revenues kommen!
Aber eine Übernahme zum doppelten Marktpreis ist jederzeit drin, was ich nicht hoffe!
Das größte Plus für uns, alleinige Rechte weltweit an Provenge dadurch ein ROW-Partner auch jederzeit möglich...

Für mich überwiegen die Vorteile ganz klar gegenüber den Nachteilen bei solchen pre-approval-Kursen!

Gute Nacht

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.170.176 von Magnetfeldfredy am 04.10.11 22:41:39

Deutsche Bank Expects "Uptick" for Dendreon in Early 2012




By Joe Young
Benzinga Staff Writer
October 06, 2011 9:36 AM




Symbols: DNDN

Tags: Deutsche Bank

Posted in: News, Analyst Color, Short Ideas, Analyst Ratings, Trading Ideas




inShare.





Share








Last night, Deutsche Bank published a research report on Dendreon (NASDAQ: DNDN) citing that the "uptick" for Provenge could likely come in 1Q 2012.

In the report, Deutsche Bank writes, "It is DB's take the timing of a significant uptick for Provenge will most likely come 1H12/mid-2012. According to the CFO, many centers are saying they want to see 4-6 patients are FULLY reimbursed before adding more patients/month. They think a cycle takes on average 2.5 months to [prescribe], treat, & reimburse. As many started online early to mid-year 2011, this suggests we could see an "uptick" anywhere between 1Q and 2Q12."

Deutsche Bank maintains its Buy rating and $20 price target on Dendreon at the time of the published report.

Dendreon closed yesterday at $9.00 and is currently trading up $0.22 today since market open.

[Marchella]

07.10.2011
Krebsvorsorge

USA schaffen umstrittenen Prostata-Test ab

Von Cinthia Briseño


Gefährliche Medizin? Mit dem sogenannten PSA-Test wollen Ärzte Prostatakrebs entdecken. Doch das Verfahren gilt als unsicher, gesunde Männer werden irrtümlich operiert. Die US-Regierung will jetzt die Kostenübernahme ganz abschaffen. Deutschen Urologen geht dieser Vorstoß aber zu weit.

http://www.spiegel.de/wissenschaft/medizin/0,1518,790439,00.…

[edelupolino]

Medizinisch gute neuartige Produkte auf dem Markt zu etablieren, scheint schwierig zu sein.
Dies wird auch in IV angesprochen, z.B.von LookoutJoe:


Re: My recent Seeking Alpha article...
"Dendreon is being out marketed by big pharma, who obviously is fighting the introduction of immunology into the medical field for treating cancer. "

That is why it is so important for Dendreon to finally get a pharma on board, in any capacity. Once that occurs, the playing field will be level, as least with regard to exposure.

LookoutJoe


Ciao Ede

[Kursziel1000]

Turnaround sollte nun nachhaltig hier erfolgen. Aktie hat heute fast auf Tageshoch bei $9.84 geschlossen. Das Volumen lag heute bei 6M Aktien Tendenz weiter steigend.
Bricht die $10 Marke dürfte der Zug erst richtig ins Laufen kommen, da aktuell noch 21.8M Aktien short sind!

[Magnetfeldfredy]

It's Not Too Late to Buy These Cheap Stocks

By Jim Mueller | More Articles
October 13, 2011 | Comments (0)


This article is part of our Rising Star Portfolios series.

It's been just shy of a year since the launch of The Motley Fool's Rising Star Portfolios, and my value-investing Messed-Up Expectations approach is doing just about what you'd expect in a tough market environment. The past few months have been especially difficult, but I've been doing what any long-term investor should be doing -- buying shares of beaten-up companies.

Today, I'm going to bring the positions of three companies back up to a 2% position of investable funds, given that the Fool has decided to continue funding this portfolio. The great thing for me and this portfolio is that all the share prices are near or below the price at which I originally purchased them.



Company

Purchased

Recent Share Price

Current Expectations*



SUPERVALU (NYSE: SVU )

2/1/11 @ $7.30

$7.66

(25.9%) / (13%) / 0%



Hertz Global (NYSE: HTZ )

4/21/11 @ $17.18

$10.59

(0.9%) / (0.5%) / 0%



Dendreon (Nasdaq: DNDN )

8/11/11 @ $10.15

$9.00

NM


*Expectations are the growth rates for one to five years / six to 10 years / 10 years from trailing free cash flow needed to justify the recent price using a discount rate of 15% in a DCF model. NM = not meaningful.

The thesis for SUPERVALU involved a big disconnect between what the equity market and the debt market were expecting. That hasn't changed, given current expectations. Further, the company was in the midst of a turnaround, going from "terrible" to "merely bad." That has continued, with further repayment of debt (from $7.33 billion when I bought to $6.69 billion most recently) while at the same time seeing declining same-store sales but improving costs. In an environment where even Wal-Mart Stores (NYSE: WMT ) is having difficulty with same-store sales, it's nice to see that this investment thesis is still intact. I'll be adding enough money to this position to bring it back up to the 2% level.

Hertz's thesis, too, is still intact. This includes growing sales and net income as well as improving fundamentals like residual value (so that its used cars can be sold at higher prices) and declining days sales outstanding. The equipment-rental side of the business is doing well, also, with more equipment being rented at higher prices. Hertz is also now the only major bidder for Dollar Thrifty (NYSE: DTG ) , with Avis Budget Group (Nasdaq: CAR ) having dropped out. That should give Hertz a nice boost to growth. With shares down substantially from when I purchased them, little change to the priced-in expectations, and a still-intact thesis, I'm comfortable bringing this back up to a full, but small, position.

Finally, the situation at Dendreon is slowly improving. This stock was purchased after the market's strongly negative reaction to sharply reduced Provenge sales guidance came out. Dendreon has since made several steps toward improving the situation, including cutting its workforce to reduce costs and educating prescribing physicians better on Medicare reimbursement. Reimbursement time is now down to 30 days, and one physician reported reimbursement within eight days. Plus, worries about competition from Johnson & Johnson's (NYSE: JNJ ) Zytiga are abating, as that is currently only being used in third- and fourth-stage cancers, which is not where Provenge is used. These are good things to see, and they demonstrate that management is getting a handle on this situation to turn it around. Thus, I have no problem adding more money to this investment, bringing it back up to a full 2% position.

[GuHu1]

nun ja kennt man:
http://www.rush.edu/webapps/MEDREL/servlet/NewsRelease?id=15…" target="_blank" rel="nofollow ugc noopener">
http://www.rush.edu/webapps/MEDREL/servlet/NewsRelease?id=15…

[GuHu1]

Antwort auf Beitrag Nr.: 42.215.812 von GuHu1 am 14.10.11 23:16:00

http://www.rush.edu/webapps/MEDREL/servlet/NewsRelease?id=15…

[edelupolino]

Hi an alle,
wollte mir gerade dieses Buch kaufen, um es in aller Ruhe zu lesen und dann an interessierte Freunde weiterzugeben.

The Dendreon Effect: How Felons, Con-men and Wall Street Insiders Manipulate High-tech Stocks (M. Mitchell)

Es war bei Amazon nicht zu haben, dito bei Barnes&N.!

Ciao Ede

[GuHu1]

Dendreon Begins Enrollment in Phase 2 Neu-ACT Trial for Second Active Cellular Immunotherapy Product Candidate, DN24-02

http://finance.yahoo.com/news/Dendreon-Begins-Enrollment-in-…

[GuHu1]

Antwort auf Beitrag Nr.: 42.218.605 von edelupolino am 16.10.11 20:46:21

hi ede, kannst ja vorab hier schon mal schmökern

http://www.deepcapture.com/wp-content/uploads/story-of-dendr…

[03482]

Antwort auf Beitrag Nr.: 42.223.064 von GuHu1 am 17.10.11 21:27:24

Ich hab mir die 80 Seiten auf meinen Kindle geladen und freue mich auf das Lesevergnügen !

[edelupolino]

Antwort auf Beitrag Nr.: 42.223.064 von GuHu1 am 17.10.11 21:27:24

Hi GuHu1,
Danke! Werde da auf jeden Fall reinschauen.

Hier eine Seite über "zytiga side effects":

http://www.investorvillage.com/smbd.asp?mb=971&mn=421547&pt=…

Ciao Ede

[GuHu1]

Antwort auf Beitrag Nr.: 42.225.540 von edelupolino am 18.10.11 13:05:28

Re: Deutsch Bank Bio - DNDN (Buy) - **Zytiga read-thru from JNJ call for Provenge**
Sounds like interim didn't cut it.
If so... post-chemo interim hits, but pre-chemo does not. Raises doubts about hitting final overall survival endpoint in pre-chemo it would seem?. Proving to be a tougher disease setting than post chemo? This on top of still no publication of pre-chemo phase 2 data?


http://www.investorvillage.com/smbd.asp?mb=971&mn=421562&pt=…

Deutsch Bank Bio - DNDN (Buy) - **Zytiga read-thru from JNJ call for Provenge**

Classification: Public

>From JNJ call this morning, we're highlighting comments on Zytiga which could have a read-thru to DNDN's Provenge
*Not counting on interim look in Q4 but waiting on overall survival data. So JNJ is guiding to filing on overall survival
*This should bode well for DNDN b/c overall survival endpoint will take longer giving them more lead time for 1L in US and EU
*Zytiga contributed 1.5 points of growth to pharmaceutical business compared to same quarter last year.

haut wohl nicht hin mit den daten für zytiga....

[GuHu1]

Antwort auf Beitrag Nr.: 42.223.064 von GuHu1 am 17.10.11 21:27:24

http://www.investorvillage.com/smbd.asp?mb=971&mn=421581&pt=…

in verbindung mit dem deep capture pdf wird klar was der autor des postings meint.

[edelupolino]

Antwort auf Beitrag Nr.: 42.228.712 von GuHu1 am 18.10.11 22:09:00

haut wohl nicht hin mit den daten für zytiga

Etwas Schöneres kann uns nicht passieren: das ist das Richtige für diese über Leichen gehende Scher-etc-Mafia.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.230.663 von edelupolino am 19.10.11 11:20:01

Hi Ede,

Bid in Frankfurt mit 10.000 Stück zu 7,05 EUR!

Daß ist für jeden eine zweite "big chance" mit Dendreon viel Geld zu verdienen!

Schönen Tag noch!

Einmal Dendrone immer Dendrone!

Fredy

[GuHu1]

http://www.hemonctoday.com/article.aspx?rid=87874

[edelupolino]

Antwort auf Beitrag Nr.: 42.234.158 von GuHu1 am 19.10.11 21:31:45

@ GuHu1 und Fredy

...schöner Artikel über die Vaccine, die vielen Menschen Hoffnung geben.

Für Dndn muss das aber bedeuten, die eigenen Vorteile und das Know-How endlich richtig und mit echter/überzeugender Werbekampagne überall herauszustellen.

Es reicht nicht, die ERSTEN gewesen zu sein; jedes neue Produkt ist in unserer Gesellschaft nur dann etwas wert und kann sich nur dann gegen Konkurrenten durchsetzen, wenn es richtig vermarktet wird.
Daran scheint/schien es zu hapern.

[GuHu1]

Antwort auf Beitrag Nr.: 42.237.748 von edelupolino am 20.10.11 16:30:50

analysten rechnen durchschnittlich mit $62,8m für q3, was wird dndn am 02.11.11 vermelden?

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.244.983 von GuHu1 am 22.10.11 00:09:09

Hoffentlich mehr!

[GuHu1]

Antwort auf Beitrag Nr.: 42.225.540 von edelupolino am 18.10.11 13:05:28

ich hoffe du hast das pdf.... das war es nämlich vorerst damit

http://www.theprovince.com/news/Vancouver+stock+promoter+get…

http://mindbodypolitic.com/2011/10/22/patrick-byrnes-deep-ca…

[edelupolino]

Antwort auf Beitrag Nr.: 42.246.534 von GuHu1 am 23.10.11 01:26:40

Ich habe mir einige Seiten noch einmal durchgelesen, und warte nun darauf, dass irgendein Verlag sich traut, das Buch zu veröffentlichen.
Ich hoffe, dass nicht alle dort beschriebenen "Figuren" mit evtl Klagen durchkommen - es wäre jammerschade, wenn man am Ende nur statt eines Buches eine Mini-Broschüre lesen könnte.

[edelupolino]

And our asshole management just continues to sell.

...zitiert aus einem Beitrag eines wütenden Dendreonen, der wohl gern Käufe des Management sehen würde: (http://www.investorvillage.com/smbd.asp?mb=971&mn=422092&pt=…)

Ich hab mal nachgesehen, wieviel verkauft wurde: relativ wenige Stücke.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.256.393 von edelupolino am 25.10.11 18:27:56

Tortzdem, muß das sein, die haben doch schon genug Kohle gemacht und Vertrauen schaffen sie damit nicht!

[edelupolino]

Antwort auf Beitrag Nr.: 42.256.399 von Magnetfeldfredy am 25.10.11 18:29:25

ist mir auch recht schleierhaft, wie diese Vertreter des großen Geldes immer wieder zur (un)rechten Zeit verkaufen.

Stimme dir zu, dass z.B. shorts durch einen mutigen Zukauf von eigenen Aktien ins Grübeln kommen würden; nach dem Motto: "Muss ich jetzt etwa long gehen???"

Und es gibt nichts Schöneres in der Welt der Aktien, den shorts Feuer unterm Hintern zu machen.

Aber mit diesem Management (muss mich hier mal den Klagerufen einiger Leute aus IV anschließen!)

[edelupolino]

Antwort auf Beitrag Nr.: 42.257.482 von edelupolino am 25.10.11 21:43:23

hier der Beitrag eines sich verfolgt/verarscht fühlenden Schreibers aus IV:


http://www.investorvillage.com/smbd.asp?mb=971&mn=422109&pt=…


Ich sage nur "Gute Nacht, Freunde!" (ich WILL dem Burschen nicht glauben.)

[GuHu1]

Antwort auf Beitrag Nr.: 42.257.482 von edelupolino am 25.10.11 21:43:23

es ist so wie es ist und es hat sich daran (seit 2007) nichts geändert.
hat das mngm. vor der zulassung shares gekauft?

derzeit sind 716 infusion centers (steigend) zugelassen, macht jeder einen patienten/monat kommen wir bei $93.000/patienten auf einen jahresumsatz von?
das rechen spiel kannst du treiben wie du willst....

ich warte auf die zahlen von sept (jul + aug sind bekannt), da erst greift der Q-Code richtig, IMO.
____

auch eine meinung aus dem IV:

http://www.investorvillage.com/smbd.asp?mb=971&mn=421969&pt=…

12 Patients per Month at one center
Dana Farber Cancer institute in a Q&A on Provenge expects to prescribe to 12 patients per month. Check out link and scroll towards bottom.
Folks, there is a tsunami of uptake by the country regarding Provenge in my opinion and this is just one tell of many.

http://www.dana-farber.org/Health-Library/Provenge®----Freq…

EDIT: Above link my give you an error. If so, try www.dana-farber.org

Then in the search window for the website type Provenge and you'll see the link to the Q&A I am referencing.

[edelupolino]

Antwort auf Beitrag Nr.: 42.257.818 von GuHu1 am 25.10.11 23:04:45

Das Zahlenspiel macht richtig Spaß.
Wenn Organisation, Sorgfalt und medizinisch saubere Methodik wie ein Rad ins andere greifen, sehe ich große Möglichkeiten.

Aber als an vielen möglichen Fronten gebranntes Kind (Verkauf von Insideraktien ist noch das geringste)bin ich nur noch vorsichtig optimistisch, aber optimistisch.

[Biohero]

Trotz des massiven absturz von über $40 auf $10 wird weiterhin fleißig aktien von den Insidern verkauft und der rasante anstieg des short interest deutet erneut auf schlechte Quartalszahlen hin die nächste Woche veröffentlicht werden .

Also ich würde die Aktie meiden zumindest bis nach den Zahlen .Ich persönlich sehe keine grosse Zukunft für das Unternehmen wegen der extrem hohen Burn-rate und den schlechten Verkaufszahlen dazu kommt noch das weitere konkurrenten auf den Markt gekommen sind .


Insider verkaufen
http://www.nasdaq.com/asp/quotes_sec.asp?symbol=DNDN&selecte…


Short interest erreicht neues 52W hoch
http://www.nasdaq.com/symbol/dndn/short-interest

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.260.076 von Biohero am 26.10.11 14:19:55

Du hast aber viel Ahnung von Dendreon!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.261.230 von Magnetfeldfredy am 26.10.11 17:19:52

It's Crunch Time For Dendreon
by: Theodore Cohen October 26, 2011 | about: DNDN Font Size: PrintEmail Recommend 1 Share this page
Share Dendreon (DNDN) is pushing against the 50-day moving average, which currently stands at $10.64. The stock was turned back from this area this morning, as you might expect, in the absence of news.

Clearly, the Street is waiting for the 3Q11 results to be announced on November 2, after the close (see below). With the current count of Provenge providers now at 722 (up 20% from early August), Medicare reimbursement issues behind us (the Q-code was published in early August), the ease with which Provenge providers can qualify patients (using simple bone scans), and a new marketing team at the helm, I am sanguine that the company will exceed the Street’s conservative expectations, which currently posit sales in the low-to-mid $60-million-range for the third quarter. I would expect (but of course do not know) that the company also will provide some indication of the sales achieved for October, 2011. Remember, once the company achieves $500 million in sales, it is cash flow-positive, something that should happen 1H12, and possibly as early as 1Q12.

If the company surprises the Street on November 2, I would expect the stock to move smartly through the 50-day moving average and begin a new uptrend. Next stop: the low $20s, as seen in the weekly chart, where the 200-week moving average is just over $22. Note that on the weekly chart, the stock still is oversold. Importantly, however, the weekly MACD line is just about to turn positive (black line to thrust up through the red line), suggesting that the smart money will begin buying again, once it sees signs that the company has "righted the ship."

Stay tuned, especially on November 2.

Charts courtesy of Stockcharts.com:





The information below, from the Dendreon Web site, will be useful in finding presentations of interest. Click here for more.


Webcasts and Presentations

Nov. 2, 2011 at 4:30 p.m. ET

Q3 2011 Dendreon Earnings Conference Call

Nov 15, 2011 at 9:00 AM ET

Lazard Healthcare Conference

Nov 9, 2011 at 8:30 AM MT

Credit Suisse Healthcare Conference

Disclosure: I am long DNDN.

Additional disclosure: I am long DNDN and will not alter my position within 72 hours of the time of publication of this article.
This article is tagged with: Long & Short Ideas, Long Ideas, Healthcare, Biotechnology, United States
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[GuHu1]

Antwort auf Beitrag Nr.: 42.260.076 von Biohero am 26.10.11 14:19:55

"...und der rasante anstieg des short interest deutet erneut auf schlechte Quartalszahlen hin..."

nachdem der ausblick für 2011 zurückgezogen wurde, geht der durchschnitt der analysten von 62,8M für q3 aus.

was sind aus deiner sicht schlechte q zahlen?
kleiner 62,8M
gleich 62,8M

nur mal so, Jul = 19M bekannt, Aug = 22M bekannt, Sep = (21,8 schätzen die analysten). vieleicht bekommen wir auch einen Ausblick auf den Oktober...

hier schrieb mal einer es gäbe keine provenge nachfrage. das würde dann heißen, schlechte q3 zahlen = kein wachstum.

jedenfalls wächsen die anzahl der infusion centren, letzter stand 722, weiter wachsend.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.268.259 von GuHu1 am 27.10.11 18:30:47

Das wäre nicht schlecht:

All Eyes On Dendreon With Earnings Set For Wednesday
by: VFC's Stock House October 30, 2011 | about: DNDN, includes: JNJ Font Size: PrintEmail Recommend 0 Share this page
Share0 inShare0The short term potential of Dendreon (DNDN) is set to play itself out this week, with the third quarter earnings report set for Wednesday, November 2nd. Following the blood bath that ensued following the company's last earnings report - which included a drastic revision of year-end Provenge sales expectations, - this report will be key for convincing investors that the reimbursement problems that plagued the company earlier this year are now in the rear view mirror.

The potential is there for a swift turnaround.

Even given the dire news and drastic restructuring of the previous few months, Provenge sales still came in at over $50 million for the second quarter. Given the already-established growth trends, and assuming that the reimbursement issues have been somewhat solved, it's likely that Provenge sales could approach or surpass the eighty million dollar mark for the quarter; far from allowing the company to achieve the previous sales guidance levels, but maybe enough to reinstill investor and market confidence enough to push shares again closer to twenty dollars.

In anticipation of the upcoming earnings report, shares of Dendreon were trading higher all week last week before closing Friday at $11.29. It's true that some of that rebound could be more attributed to the broad market rebound as the result of positive news on the economic front from Europe, but it's also likely that some shorts were looking to cover and other positions were being established in anticipation of this report.

Another disappointment, however, or a swift downturn in the economic recovery could send shares back below ten dollars in a hurry, so it's imperative that investors are given the impression that reimbursement is no longer an issue and that Provenge is gaining traction in the market, even with new competition hitting the market in the form of Johnson & Johnson's (JNJ) Zytiga.

Dendreon options were up last week as well, but only Wednesday will tell us if the rebound is for real or not.

Disclosure: I am long DNDN.

[GuHu1]

Antwort auf Beitrag Nr.: 42.276.587 von Magnetfeldfredy am 30.10.11 07:23:24

even with new competition hitting the market in the form of Johnson & Johnson's (JNJ) Zytiga.
Zytiga ist d.z. kein konkurrent.... da es laut label nach provenge zur anwendung kommt.

auszug nebenwirkungsprofil zytiga:
http://www.drugs.com/sfx/zytiga-side-effects.html#
Cardiovascular
Cardiovascular side effects have included hypertension, edema, hot flushes, arrhythmias, atrial and ventricular tachycardia, supraventricular tachycardia, atrial flutter, bradycardia, AV block, chest pain or discomfort, angina, left ventricular dysfunction, cardiogenic shock, cardiomegaly, cardiomyopathy, decreased ejection fraction, and heart failure.

auszug nebenwikungsprofil provenge:
http://www.drugs.com/sfx/provenge-side-effects.html#
Cardiovascular
Cardiovascular side effects have included peripheral edema and hot flashes.

[GuHu1]

Antwort auf Beitrag Nr.: 42.268.259 von GuHu1 am 27.10.11 18:30:47

http://www.businesswire.com/news/home/20111102006921/en/Dend…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.293.373 von GuHu1 am 02.11.11 21:07:59

Solides Quartal, aber keine großartigen Neuigkeiten auf dem CC!

[Biohero]

Antwort auf Beitrag Nr.: 42.260.076 von Biohero am 26.10.11 14:19:55

Trotz des massiven absturz von über $40 auf $10 wird weiterhin fleißig aktien von den Insidern verkauft und der rasante anstieg des short interest deutet erneut auf schlechte Quartalszahlen hin die nächste Woche veröffentlicht werden .

Also ich würde die Aktie meiden zumindest bis nach den Zahlen .Ich persönlich sehe keine grosse Zukunft für das Unternehmen wegen der extrem hohen Burn-rate und den schlechten Verkaufszahlen dazu kommt noch das weitere konkurrenten auf den Markt gekommen sind .



Hab doch gesagt die Q-Zahlen werden nicht gut sein . DNDN hat ganze 147 million dollar in nur einem Q verbrannt nur um einen Umsatz von 66 Million zu erzielen das nenne ich mal ne leistung .

Kurs bricht nachbörslich ein ...Würde die Aktie weiterhin meiden

[Ville7]

Ein Highflyer, der nun tief gestürzt ist. Nachdem die Verkäufe von Provenge alles andere als gut laufen und die Wachstumserwartungen flach sind reicht das Cash nicht mehr allzu lange bevor die Firma vor die Hunde geht. Die Börse quittiert es nachbörslich entsprechend mit minus 22% (ausgehend von einem eh schon im Laufe des Jahres mehr als geviertelten Wert).

Kommt mit Dendreon die nächste Biotech-Katastrophe?

[MrBean07]

Antwort auf Beitrag Nr.: 42.294.213 von Ville7 am 03.11.11 06:21:23

Kommt mit Dendreon die nächste Biotech-Katastrophe?

Aber nein, die Katastrophe ist schon da. Die Firma ist eine Geldverbrennungsmaschine mit einem Nischenprodukt, aber immer noch 1,4 Milliarden an der Börse wert. Der Kurs wird sich zehnteln auf ca. 50 Cents und dann wird vielleicht ein Käufer kommen. An sich sind solche Nischenprodukte und Orphan Drugs ja absolut "in" bei big pharma, aber mehr als 5 Jahresumsätze würden die niemals zahlen ..

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.294.515 von MrBean07 am 03.11.11 08:40:26

Jetzt kommen die "Kellerasseln" wieder raus, Dendreon hat ca. 60 Millionen revenues im Quartal, 500 Millionen cash und alle Rechte weltweit auf Provenge, EU-Partner, ROW-Partner möglich!
Es dauert bis ein Produkt ankommt aber Du bist ein Nullchecker!

[barabo]

Zitat von MrBean07: Kommt mit Dendreon die nächste Biotech-Katastrophe?

Aber nein, die Katastrophe ist schon da. Die Firma ist eine Geldverbrennungsmaschine mit einem Nischenprodukt, aber immer noch 1,4 Milliarden an der Börse wert. Der Kurs wird sich zehnteln auf ca. 50 Cents und dann wird vielleicht ein Käufer kommen. An sich sind solche Nischenprodukte und Orphan Drugs ja absolut "in" bei big pharma, aber mehr als 5 Jahresumsätze würden die niemals zahlen ..

Naja, der bereinigte Quartalsumsatz lag bei knapp 70 Millionen und dass diese Marke erst der Anfang ist, sollte jedem klar sein.
Selbst bei 70 Mill. beträgt der Jahresumsatz = 280 x 5 Jahre = 1,4 Milliarden. Insofern ist DNDN fair bewertet, wenn man das Wachstumspotential ignorieren würde.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.294.818 von barabo am 03.11.11 09:43:22

dazu die weltweiten Rechte mit Verpartnerung.....

Dendreon ist jetzt ein spotbilliger buyout Kandidat mit Kursziel von 15-20 US Dollar!

big pharma scharrt schon mit den Hufen, so billig bekommen sie DNDN nie wieder!

[Biohero]

Antwort auf Beitrag Nr.: 42.294.818 von barabo am 03.11.11 09:43:22

@barabo

Die Ausgaben sind mehr als doppelt so hoch wie die Einnahmen (Griechenland lässt grüssen) bleibt das so und danach sieht es aus dann ereilt DNDN dasselbe schicksal wie den Griechen .

Was mich noch stört sind die brutalen Schulden von 560 millionen dollar und natürlich die extrem hohe burn rate von mehr als 100 million pro Quartal .

Ich denke eine neue Kapitalerhöhung wird bald folgen .

FAZIT : Ich würde die Aktie nicht anfassen

[barabo]

Antwort auf Beitrag Nr.: 42.296.325 von Biohero am 03.11.11 13:26:39

Klar, m.E. wird sich um Zuge einer Bodenbildung, die es jetzt abzuwarten gilt, eine Chance auftun.

Im CC hieß es, dass sich ab 500 Mill. Umsatz (Jahr) Gewinn einstellt und im Oktober wurden 26 Mill. umgesetzt.

Auf´s Jahr gerechnet also gute 300 Millionen plus den Umsatzsteigerungen. Dieser Umsatz fällt allerdings allein in Nordamerika an und wenn ab Ende 2012 Europa hinzukommt, dann sind ab Mitte 2013 durchaus das Überschreiten der 500 Millionen drin. Dann muss man noch das Entwicklungspotential der Pipeline berücksichtigen und schon rechtfertigen sich wieder Kurse im Bereich von 20 $.

Wer also nach Abschluss der nun bevorstehenden Bodenbildung zuschlägt, wird m.E. seinen Schnitt machen. Den Boden erwarte ich im Bereich von ca. 6 $.

[Hobbyaktien]

Kann mir bitte jemand hier einen Realtime Chart aus den USA von Dendreon hier einstellen??

Das wäre echt super nett!

Danke!

[ericcartman]

Typische Ami-Blase, da wird der Kurs auf nahezu 52 Dollar hochgepumpt und nun findet erst die wahre Preisbildung statt. Ein Blick über die ganzen Biotec-Buden sagt ja alles. Verdienen tun meist nur die Administration und wenn es mittel Splits oder Aktienofferten ist.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.297.065 von ericcartman am 03.11.11 15:08:12

52 Dollar war genauso deppert wie jetzt 6 US Dollar, der Tiefpunkt ist nahe:

heute, 16:27 BREAN MURRAY & CO
Dendreon "sell"

New York (aktiencheck.de AG) - Jonathan Aschoff, Analyst von Brean Murray Carret & Co, stuft die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) mit "sell" ein. Das Kursziel werde bei 6 USD gesehen. (Analyse vom 03.11.2011) (03.11.2011/ac/a/a)


.
.
Offenlegung von möglichen Interessenskonflikten: Das Wertpapierdienstleistungsunternehmen oder ein mit ihm verbundenes Unternehmen betreuen die analysierte Gesellschaft am Markt. Weitere mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen.


Auch von heute:

heute, 14:27 RBC CAPITAL MARKETS
Dendreon "sector perform"

Toronto (aktiencheck.de AG) - Michael J. Yee, Jason Kantor, Charmaine Chan und Adnan Butt, Analysten von RBC Capital Markets, stufen die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) mit dem Rating "sector perform" ein. Das Kursziel werde bei 15 USD gesehen. (Analyse vom 03.11.2011) (03.11.2011/ac/a/a)


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[pokemon]

wird richtig spannend!

[huetchen6]

Hier etwas aus dem Jahr 2001 Okt.
Frage, wer hat die ganzen Jahre finanziert, wer bekommt Provenge.
Behandlungspreis ca. 90.000 .- Dollar.
10 Mann = 900.000.- Dollar
100 Mann 9.000.000.- Dollar
1000 Mann u.s.w.



Dendreon Corporation and Gambro team up for US cell collection network for commercialization of cancer vaccine therapy Dendreon Corporation und Gambro-Team für US Zellsammlung Netzwerk für die Vermarktung der Krebs-Impfstoff-Therapie 10/24/2001 7:54 EST 2001.10.24 07.54 EST

Dendreon Corporation and Gambro team up for US cell collection network Dendreon Corporation und Gambro-Team für US Zellsammlung Netzwerk
for commercialization of cancer vaccine therapy für die Vermarktung der Krebs-Impfstoff-Therapie

Stockholm, Sweden, October 24, 2001 Gambro AB (Stockholmsbörsen: Stockholm, Schweden, 24. Oktober 2001 Gambro AB (Stockholmer:
GAMBaST, GAMBbST), a leading international medical technology and GAMBaST, GAMBbST), ein international führender Medizin-und
healthcare company, today announced that Gambro and Dendreon Corporation Healthcare-Unternehmen, gab heute bekannt, dass Gambro und Dendreon Corporation
(Nasdaq: DNDN) will team up to support the commercialization of (Nasdaq: DNDN) wird sich zusammen, um die Kommerzialisierung der Unterstützung
Dendreon's therapeutic vaccines. Dendreon die therapeutische Impfstoffe. Gambro Healthcare's US network of Gambro Healthcare US-Netz
clinics will serve as cell collection centers and Gambro BCT's COBE Kliniken wird als Zelle Sammelstellen und Gambro BCT ist COBE dienen
SpectraTM Apheresis System, will be used for the cell collection SpectraTM Apherese-System wird für die Zelle Auflistung verwendet werden
procedure. Verfahren. The collected cells serve as a raw material component in the Die gesammelten Zellen dienen als Rohstoff-Komponente in der
prodution of Dendreon's cancer vaccines. prodution der Dendreon-Krebs-Impfstoffe.

"We are excited about the opportunity to team with Dendreon and expand "Wir freuen uns über die Möglichkeit, Team mit Dendreon gespannt und erweitern
our business to serve this new group of patients. unser Geschäft zu dienen diese neue Gruppe von Patienten. These new patient Diese neuen Patienten
services fit within the strategic direction of Gambro Healthcare, which Dienstleistungen passen in die strategische Ausrichtung der Gambro Healthcare, die
is focused on providing value-added services that leverage our core ist auf die Bereitstellung von Mehrwertdiensten, die unser Kerngeschäft nutzen fokussiert
competencies and our clinical network," says Larry Buckelew, President Kompetenzen und unsere klinischen Netzwerk ", sagt Larry Buckelew, Präsident
of Gambro Healthcare US. von Gambro Healthcare USA.

David Perez, President of Gambro BCT said, "Gambro BCT's Spectra David Perez, Präsident von Gambro BCT sagte: "Gambro BCT Spectra
apheresis system is the premier device for stem cell collection. Apherese-System ist das erste Gerät für die Stammzell-Sammlung. This Dieses
superior technology, along with the clinical and technical expertise of überlegene Technologie, zusammen mit der klinischen und technischen Know-how der
Gambro BCT and Gambro Healthcare, provides a basis for our Therapeutics Gambro BCT und Gambro Healthcare, bietet eine Grundlage für unsere Therapeutics
business strategy: delivering valued blood therapy innovations to Business-Strategie: Bereitstellung von geschätzten Blut-Therapie Innovationen
improve clinical outcomes for patients. Verbesserung der klinischen Ergebnisse für Patienten. It is also an outstanding Es ist auch eine hervorragende
opportunity for collaboration between Gambro Healthcare and Gambro BCT." Möglichkeit zur Zusammenarbeit zwischen Gambro Healthcare und Gambro BCT. "

The agreements will provide Dendreon with a network of cell collection Die Vereinbarungen werden Dendreon mit einem Netzwerk von Zellen Sammlung bieten
centers to support clinical development and commercial production of Zentren für die klinische Entwicklung und die kommerzielle Produktion von Unterstützung
Dendreon's therapeutic vaccines, including its lead product ProvengeTM. Dendreon die therapeutische Impfstoffe, ua das Hauptprodukt ProvengeTM.
Dendreon recently announced the completion of patient enrollment in the Dendreon gab kürzlich den Abschluss der Patientenaufnahme in die
first of its Phase III clinical trials of Provenge in patients with erste seiner Phase III-Studien für Provenge bei Patienten mit
hormone refractory prostate cancer. hormonresistentem Prostatakrebs.

"This agreement solidifies a key element of our Provenge "Diese Vereinbarung festigt ein Schlüsselelement unserer Provenge
commercialization strategy," said Christopher S. Henney, Ph.D., D.Sc., Vermarktungsstrategie ", sagte Christopher S. Henney, Ph.D., D. Sc,
Chairman and CEO of Dendreon. Chairman und CEO von Dendreon. "By tapping into Gambro's vast clinical "Durch die Erschließung weite klinische Gambro
network and cell collection expertise, we will be able to streamline Netzwerk-und Zell-Sammlung Know-how werden wir in der Lage sein zu straffen
Provenge therapy to enhance convenience and accessibility for patients Provenge Therapie Bequemlichkeit und Erreichbarkeit für die Patienten verbessern
and physicians." und Ärzte. "

Prostate cancer is the most commonly diagnosed cancer among American Prostatakrebs ist die am häufigsten diagnostizierte Krebserkrankung bei amerikanischen
men. Männer. More than one million men in the United States have prostate Mehr als eine Million Männer in den Vereinigten Staaten haben Prostata
cancer, with 198,000 new cases and 31,500 deaths estimated in 2001. Krebs, mit 198.000 Neuerkrankungen und 31.500 Todesfällen im Jahr 2001 geschätzt.
There is currently no treatment that increases the long-term survival of Derzeit gibt es keine Behandlung, die das langfristige Überleben des Anstiegs
patients with metastatic prostate cancer. Patienten mit metastasiertem Prostatakrebs.

Dendreon Corporation (www.dendreon.com) is dedicated to the discovery Dendreon Corporation (www.dendreon.com) ist auf die Entdeckung gewidmet
and development of novel products for the treatment of cancer through und Entwicklung neuartiger Produkte für die Behandlung von Krebs durch
its innovative manipulation of the immune system. seine innovative Manipulation des Immunsystems. Dendreon is a leader Dendreon ist ein führendes Unternehmen
in the development of therapeutic, dendritic cell-based cancer vaccines. in die Entwicklung von therapeutischen, dendritischen Zellen basierende Impfstoffe gegen Krebs.
In addition to Provenge, Dendreon has two therapeutic vaccines in Zusätzlich zu Provenge hat Dendreon zwei marktnahe therapeutische Impfstoffe in
clinical trials - MylovengeTM, for the treatment of multiple myeloma, in klinischen Studien - MylovengeTM, für die Behandlung des multiplen Myeloms, in
Phase II trials; and APC8024, for the treatment of breast, ovarian and Phase-II-Studien, und APC8024, für die Behandlung von Brust-, Eierstock-und
colon cancers, in Phase I trials. Darmkrebs, in Phase I-Studien.

Except for historical information contained herein, this news release Abgesehen von hierin enthaltenen historischen Informationen, dieser Pressemitteilung
contains forward-looking statements that are subject to risks and enthält zukunftsgerichtete Aussagen, die Risiken und
uncertainties that may cause actual results to differ materially from Unsicherheiten, aufgrund derer die tatsächlichen Ergebnisse erheblich von den möglicherweise
the results discussed in the forward-looking statements, particularly die Ergebnisse in den zukunftsgerichteten Aussagen diskutiert, insbesondere
those risks and uncertainties inherent in the process of discovering, diese Risiken und Ungewissheiten in den Prozess der Entdeckung,
developing and commercializing drugs that are safe and effective for use Entwicklung und Vermarktung von Medikamenten, die sicher und wirksam für die Anwendung sind
as human therapeutics. als Therapeutika für den Menschen. Factors that may cause such a difference include Faktoren, die solche Abweichungen verursachen können, gehören
risks related to Dendreon's limited operating history, risks associated Risiken für die begrenzte Betriebsgeschichte Dendreon Geschichte verbunden, Risiken
with completing Dendreon's clinical trials, the risk that the safety mit Abschluss Dendreon der klinischen Studien, das Risiko, dass die Sicherheit
and/or efficacy results of a clinical trial will not support an und / oder Wirksamkeit Ergebnisse einer klinischen Studie wird nicht unterstützt eine
application for a biologics license, the risk that the FDA will not Antrag auf Erteilung einer Biologics License, die Gefahr, dass die FDA nicht
approve a product for which a biologics license has been applied, the Genehmigung eines Produkts, für die eine Biologics License angewendet wurde, die
uncertainty of Dendreon's future access to capital, the failure by Unsicherheit der zukünftigen Zugang Dendreon ist das Kapital, das Scheitern von
Dendreon to secure and maintain relationships with collaborators, Dendreon zur Sicherung und Pflege von Beziehungen mit Mitarbeitern,
dependence on the efforts of third parties, and dependence on Abhängigkeit von den Bemühungen der Dritte, und die Abhängigkeit von
intellectual property. geistigen Eigentums. Further information on the factors and risks that Weitere Informationen über die Faktoren und Risiken, die
could affect Dendreon's business, financial condition and results of konnte Dendreon Geschäfts-, Finanz-und Ertragslage beeinflussen
operations, are contained in Dendreon's public disclosure filings with Operationen sind in die Offenlegung Dendreon eingereichten Unterlagen enthaltenen
the US Securities and Exchange Commission (SEC), which are available der US Securities and Exchange Commission (SEC), die verfügbar sind
at www.sec.gov. unter www.sec.gov.

For further information please contact: Für weitere Informationen kontaktieren Sie bitte:
Karin Avasalu, Vice President, Corporate Communications, tel. Karin Avasalu, Vice President, Corporate Communications, Tel.. +46-8-613 +46-8-613
65 99, [phone], [phone]
Pia Irell, Investor Relations Director, Corporate Finance, tel. Pia Irell, Investor Relations Director, Corporate Finance, Tel.. +46-8- +46-8-
613 65 91, [phone] 65 91, [phone]
Kevin Smith, President Gambro Inc., Investor Relations US, tel. Kevin Smith, President Gambro Inc., Investor Relations USA, tel. [phone]
231 4750 231 4750

[ericcartman]

Hinzu kommt, das das Medikament von Medivation deutlich besser sein soll. Daher sehe ich das KZ nicht mehr bei 14.

http://www.marketwatch.com/story/medivation-rockets-120-on-d…

[MrBean07]

Antwort auf Beitrag Nr.: 42.294.576 von Magnetfeldfredy am 03.11.11 08:56:19

Selber Nullchecker lieber Magnetfeldfredy! Infomriere dich mal über den Cashburn bei Dendreon, der den revenues gegenübersteht! Da ist eher mit einer baldigen Insolvenz zu rechnen

[GuHu1]

Antwort auf Beitrag Nr.: 42.299.201 von MrBean07 am 03.11.11 20:19:25

sofern die revenues nicht steigen gelle.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.299.201 von MrBean07 am 03.11.11 20:19:25

Ich hab genug Gewinne mit DNDN gemacht und wenn ich auch jetzt verliere, die Gewinner sind die Patienten mit Provenge denen eine Alternative zur Chemo im Endstadion geboten wird!
Geld ist nicht alles im Leben!

Wer zuletzt lacht, lacht am besten!

[GuHu1]

Antwort auf Beitrag Nr.: 42.299.543 von GuHu1 am 03.11.11 21:26:25

ISI Group - Biotech & Pharmaceuticals Analyst

This morning, MDVN just announced Phase III AFFIRM results, which showed a 4.9 month survival benefit (18.4 months vs. 13.6 in placebo) and a 37% reduction in risk ofdeath (hazard ratio of 0.631).

Recall that this study was completed in the post-chemo, metastatic CR prostate cancer setting, a similar population to that in JNJ/Cougar’s Zytiga Phase III study. According to the NEJM paper, the Zytiga study should a 3.9 month survival benefit (14.8 vs. 10.9 months in placebo) and a 35% reduction in risk of death (hazard ratio of 0.65).

We believe MDV3100 will be a direct competitor to Zytiga in the post-chemo setting, but we continue to believe that MDV310 and Zytiga could be used in sequence with Provenge and are not necessarily direct cannibalizers of Provenge sales. Also, keep in mind that Provenge is used today largely in the pre-chemo setting. Both the Zytiga and MDV3100 study readouts are in the post-chemo setting – though Phase III pre-chemo studies are underway with data for Zytiga due in 2012.

Data for these drugs in the PRE-CHEMO setting will likely present more of a possible threat to Dendreon’s Provenge, since many physicians may elect to use them ahead of Provenge. This could reduce the number of patients eligible for Provenge at any given time. However, this we’ve tried to incorporate this into our Provenge sales model. From DNDN’s point of view, success for MDV3100 over Zytiga in the market place would be a positive since MDV doesn’t require concomitant use of steroids (Zytiga does) – thus, Provenge could theoretically be used in combo with MDV, but probably not with Zytiga.

We believe investors gave a probability of success on this trial as high. Given this sentiment as well as the potential sequencing opportunities among Provenge and MDV3100, we view this news may have modest near-term impact to the stock price today but minimal impact longer-term as investors digest the news.

http://www.investorvillage.com/smbd.asp?mb=971&mn=423358&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.299.719 von GuHu1 am 03.11.11 22:05:33

Man sieht Provenge von Dendreon wird und kann noch mit vielen anderen Medikamenten eingesetzt werden und vielleicht ist ja big pharma für den Kurssturz verantwortlich um billig an Provenge zu kommen, buyout!

[GuHu1]

Antwort auf Beitrag Nr.: 42.299.719 von GuHu1 am 03.11.11 22:05:33

More from ISI Group's Mark Schoenebaum, MD

siehe link:

http://www.investorvillage.com/smbd.asp?mb=971&mn=423371&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.299.861 von GuHu1 am 03.11.11 22:37:34

Dendreon neues Kursziel

Zürich (aktiencheck.de AG) - Lee Kalowski, Analyst der Credit Suisse, stuft die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) unverändert mit "neutral" ein. Das Kursziel werde von 14,00 auf 11,00 USD gesenkt. (Analyse vom 03.11.11) (04.11.2011/ac/a/a)

[edelupolino]

Antwort auf Beitrag Nr.: 42.299.861 von GuHu1 am 03.11.11 22:37:34

@ GuHu und Fredy:
wie so oft liegt man bei Dndn "in Gottes Hand" (wer auch immer gerade Gott spielen will...): der Meinungen gibt es viele; wer letztlich recht hat???
Wer weiß schon, ob die Produktion/Organisation nicht doch plötzlich klappt? Welche rivalisierenden Produkte schränken die Nachfrage ein?
All das sind Probleme, die Raum für Spekulationen und Spekulanten (auch übler Art) lassen.

Ich find es gut , dass z.B. von Dndn-Managern gesagt wurde, dass im Winter ein Rückgang der Umsätze zu erwarten ist: das ist klar und ehrlich und beim amerikanischen Klima einsichtig: was machten interessierte Kreise aus diesen (richtigen) Angaben???
Ciao Ede

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.302.756 von edelupolino am 04.11.11 13:43:18

Die Chemo-Lobby ist wieder voll im Gange aber DNDN hat die erste Immunkrebstherapie mit voller Erstattung in Ihrem Label!Medivation muß erst zugelassen werden, Zytiga hat erhebliche Nebenwirkungen....
Jetzt braucht Dendreon einen starken ROW-Partner die dem untauglichen Management die Leviten ließt und Provenge an den Mann bringt!
DNDN auf diesem Level mit Zulassung, unglaublich..........

[Hobbyaktien]

Antwort auf Beitrag Nr.: 42.302.847 von Magnetfeldfredy am 04.11.11 13:57:29

Alles einsteigen, denke der Zug fährt gleich ab, Richtung Norden.



Alles nur meine Meinung!!

[edelupolino]

Hier einige Gedanken eines "alten IV- Hasen:

Re: Dndn : Investor vs. Speculators - Maradawn - Sam here
Your message encapsulates my viewpoint. Your phrase: >>the bottom line is : do you believe<< is key at this trying time. I think you are hearing wailing from not only speculators but investors also, because this horrible dip (opportunity) did not have to happen.

I have been on the sidelines since the 40' and 30's, with one re-entry at 9 or so and swift departure with a 12% profit a few weeks ago. This dip is what I have been awaiting for my next large market success. I have bought back in, and have a buy ladder in place, should the opposition take us lower (a real possibility). If not, I will buy on the way up when the promise of Provenge reveals itself in ever increasing droves at the infusion centres.
We are now approaching a period where my greatest caution in DNDN investing is changing. We have been fortunate (some of us, anyway) to have identified the real potential of this miracle, Provenge. It is still there, however, it becomes increasingly at risk as a money-maker, with the leapfrog technology that brings new treatments to the fore. My investment timeline will now be primarily driven by a watchful eye on who is about to eclipse our market share with their new offerings. If the management bumblers had been just mediocre at getting Provenge to the needy, we would all be quite richer at this time. It will take a bit longer, but this is the new open door to riches that Gold and company have stumbled, bumbled and fumbled us into. They have done most of the wrong things that they could - now it should be simple for them to discard the non-productive initiatives, and go forth and prosper, for us. sam
http://www.investorvillage.com/smbd.asp?mb=971&mn=423845&pt=…

Mal sehen, wie sich das alles entwickelt, und SCHADE, dass jetzt nicht das schneefreie Frühjahr anfängt!

[Magnetfeldfredy]

Servus Ede,

das Management hat viel Mist gemacht, zu hohe Ausblicke gegeben, gierig nur an sich gedacht und immer feste Aktien verkauft .....Jetzt können Sie oder andere (neuer CEO) das Ruder rumreißen, ein guter ROW-Partner wäre sehr wichtig um der Welt zu zeigen was big pharma von Provenge hält!
Ich bleib dabei!

[edelupolino]

Antwort auf Beitrag Nr.: 42.309.321 von Magnetfeldfredy am 06.11.11 19:41:10

Hi Fredy,
etwas Positives über ein chartbild, das viel vernünftiger aussieht als der chart über die vom Dndn-Management prophezeiten/angenommenen Verkäufe:

http://www.investorvillage.com/smbd.asp?mb=971&mn=423847&pt=…
Ciao Ede

PS ich nehme an, Provenge wird noch von vielen gebraucht und angenommen!

[GuHu1]

Antwort auf Beitrag Nr.: 42.309.382 von edelupolino am 06.11.11 20:00:06

grundlage dazu sind die annahmen von "guam", siehe links.
tja wie wird es sich entwickeln.....

http://www.investorvillage.com/smbd.asp?mb=971&mn=423795&pt=…

http://www.investorvillage.com/smbd.asp?mb=971&mn=423796&pt=…

[Biohero]

Jetzt wo die Zahlen raus sind und die Aktie abgestraft wurde kann man über eine kleine Position nachdenken .

Das beste wäre wenn dendreon die globale vermarktung für provenge an einem big pharma auslizensiert und weitere angestellte entlässt das würde den cash burn erheblich reduzieren und sie würden die gewinnzone schneller erreichen .

Da Provenge schon zugelassen ist kann dendreon locker einen superdeal aushandeln mit hoher upfront zahlung und double-digit royalties das würde den cashbestand weiter stärken und dendreon könnte sich entspannt um die entwickelung der anderen produkte kümmern.


Also wie gesagt die schlechten nachrichten sind erstmal raus deshalb denke ich kann man sich erste stücke ins depot legen.

[GuHu1]

huch, wußte gar nicht das dndn royalitys für Merck’s hepatitis C drug Victrelis bekommt.

nur ein kleiner auszug. franke haste dazu mehr infos.
ansonsten den folgenden thread lesen.
Because of its impressive trial results and oral formulation, analysts have predicted blockbuster sales of over $1 billion a year at its peak.

http://www.investorvillage.com/mbthread.asp?mb=971&tid=11131…

[GuHu1]

Antwort auf Beitrag Nr.: 42.314.671 von GuHu1 am 07.11.11 19:39:18

http://www.investorvillage.com/mbthread.asp?mb=971&tid=11131…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.314.688 von GuHu1 am 07.11.11 19:40:48

....und warum klärt uns vom Dendreon Management keiner auf, ich wußte gar nicht daß Dendreon dieses Medikament auslizensiert hat!

[kmastra]

Wie kann denn so etwas passieren? Das Management scheint unfähig. Das kann und darf man weder den aktionären vorenthalten noch nebenbei erwähnen. Da fehlen mir die worte.
Soweit ich weiß wird/wurden dem Medikament Umsätze im blockbusterbereich zugetraut. Lange hieß es Vertex gegen Merck. Zur Zeit scheint da Vertex die Nase vorn zu haben. Mittel- langfristig schielen aber alle wohl schon auf die ersten Medikamente ohne zusätzlich interferon-gabe. Pharmasset wird ja gerade gehypt ohne Ende.
Ansonsten muss ich biohero recht geben. Die sollen den fehler einsehen und big-pharma ins boot holen, den Zeit ist bekanntlich geld. Und ich nehme nicht an, dass Provenge bis zum Patentende das Maß der Dinge sein wird...

[edelupolino]

Antwort auf Beitrag Nr.: 42.315.194 von Magnetfeldfredy am 07.11.11 21:03:12

Dass die Typen da oben bei Dndn ÄHNLICH unfähig sind wie die "Herrscher Europas" (unsere erwählten "Volks"-Vertreter) ist leider seit langem klar: unfähig in PR, unfähig ihre unglaublich herausragende Technologie gegen die wütenden Angriffe von vielen Seiten zu verteidigen und deutlich in ihrer (bisher) Einmaligkeit herauszustellen:

ein Artikel, der mich gestern nochmal hat zuschlagen lassen (Autor ist "long" (daher verdächtig???für einige):
"...For sure Dendreon management could have done a better job of managing expectations. Perhaps, as the CEO Dr. Mitchell Gold has admitted in an interview, the company in introducing a first of its kind, paradigm shifting cancer treatment, should have just waited to see what the market acceptance of the treatment would be before guiding the financial markets as to sales expectations....." (UND VIEL MEHR!:::

http://seekingalpha.com/article/305878-dendreon-market-mania…

[Biohero]

Aussagekräftiger als irgendwelches gefasel sind Insiderkäufe und die gab es gestern nach langer zeit wieder von Schiffman & Co mit über 32000 aktien .

http://www.nasdaq.com/asp/quotes_sec.asp?symbol=DNDN&selecte…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.318.400 von edelupolino am 08.11.11 13:44:53

Danke Ede,

den hab ich schon gelesen, aber Saul war auch bei 40 US Dollar bullish, was ich auch wieder bin!
"Die Zeit heilt Wunden", ein Sprichwort, daß bei Dendreon mit vernünftigen Management passen könnte!

[edelupolino]

Antwort auf Beitrag Nr.: 42.318.582 von Biohero am 08.11.11 14:05:19

Wär ja doll, wenn neben den überzeugten aktionären auch noch der eine oder andere manager kaufen würde/könnte.

[edelupolino]

von "watchdog" (IV):

Schiffman is one SMART dude......up 10% already.

Hope he starts buying 1000 shares a MONTH for the foreseeable future.
That's what I would do.

And where is that A$$hole Gold??

He could buy a MILLION shares right here and never feel a pinch.

[GuHu1]

We met w/ DNDN senior mgmt. Key points were below:

1. The company expressed a high degree of confidence that, over time, gross margins would improve from 3Q levels to closer to 50% at ~$500M in sales (and ~70%+ at peak). Recall that this has been a major source of recent investor confusion.

2. Although mgmt has said previously that the breakeven Provenge US sales number is around $500M, they said today that if sales really did PEAK at that level, they would be able to restructure the business so that the breakeven sales number would be lower than $500M.

3. Mgmt’s view of peak sales potential of Provenge has not changed (they repeated this several times). This is why they haven’t shut down any of the manufacturing plants. Based only on our estimates of capacity for the three currently approved US plants, we suspect management’s view of peak sales is at least $2B (US only). The cost of shutting down 1 of the 3 facilities would be cost effective only if the 3rd facility was closed for at least 2-2.5 years according to the company. The start-up costs and the facility validation would be the drivers of the cost. Cash costs of closing a facility is around < $10 M.

4. The topic of bone scans received a lot of attention. Mgmt said that most docs scan every 2 years, and that they think this will increase with education and the approval of new agents (like MDV-3100 and Zytiga) in the pre-chemo setting.

Mark Schoenebaum, MD
ISI Group - Biotech & Pharmaceuticals Analyst

http://www.investorvillage.com/smbd.asp?mb=971&mn=424243&pt=…

[GuHu1]

Mäusestudie
Starkes Immunsystem schützt vor Krebs

Hoffnungsschimmer im Kampf gegen Krebs: Forscher haben bei Mäusen ein raffiniertes Abwehrsystem entdeckt. Gesunde Immunzellen versetzen potentielle Tumorzellen in eine Art Winterschlaf - so lassen sich die gefährlichen Einheiten in Schach halten.

Braunschweig - Ein starkes Immunsystem kann vermutlich Leberkrebs verhindern. Forscher des Braunschweiger Helmholtz-Zentrums für Infektionsforschung (HZI) und der Medizinischen Hochschule Hannover (MHH) berichten, dass ein gesundes und leistungsfähiges Immunsystem werdende Krebszellen in der Leber frühzeitig entdecken und abtöten kann. Ihre Erkenntnisse, die sie bei Versuchen mit Mäusen und Studien mit Patienten gewonnen haben, beschreiben die Wissenschaftler im Wissenschaftsjournal "Nature". Ein ähnlicher Mechanismus wie in der Leber könnte auch in anderen Organen eine Schlüsselrolle spielen, vermuten die Forscher.

Danach treten Zellen, die besonders gefährdet sind, zu Tumorzellen zu entarten in einen Ruhezustand, den man als Seneszenz bezeichnet. Durch die Art Winterschlaf machen sich die Zellen für das Immunsystem erkennbar und die körpereigene Abwehr, die T-Helferzellen, beginnen, diese Zellen verschärft zu überwachen und zu beseitigen, bevor Krebs ausbricht. Ein geschwächtes Immunsystem könnte die Leistung wahrscheinlich nicht in vollem Umfang erbringen, schreiben die Forscher.

Der Ruhezustand schütze fehlerhafte Zellen davor, sich unkontrolliert zu vermehren und Tumore zu bilden. "So verhindert der Körper, dass die Zellen sich weiter verändern und doch zu einem Krebs heranwachsen", erklärte Professor Lars Zender, Leiter der HZI-Forschergruppe Chronische Infektionen und Krebs.

Starke Reaktion

Um den Zusammenhang zwischen Seneszenz, Immunabwehr und Krebsentstehung zu untersuchen, lösten die Forscher das Seneszenz-Programm in Leberzellen von Labormäusen mit molekularbiologischen Methoden aus. "Wir konnten deutlich sehen, dass das Immunsystem eine starke Reaktion gegen die veränderten Zellen startet", sagte Zender. Nach einigen Wochen seien die veränderten Zellen aus dem Körper entfernt gewesen.

In Mäusen, die einen Immundefekt und daher keine T-Helferzellen zur Abwehr besitzen, konnten die Forscher beobachten, dass sich die seneszenten Leberzellen zu einem Leberzellkarzinom entwickelten. "Das zeigt deutlich, wie wichtig die Überwachung der seneszenten Zellen durch das Immunsystem und speziell durch die Helferzellen ist", erklärte Zender.

Der neu identifizierte Mechanismus biete auch eine Erklärungsmöglichkeit für die Tatsache, dass für HIV-positive Patienten ein erhöhtes Leberkrebs-Risiko besteht. "Bei HIV-Patienten ist die Immunabwehr durch T-Helferzellen beeinträchtigt, so dass in Lebern von HIV Patienten seneszente Leberzellen wahrscheinlich nicht effektiv entfernt werden können."

Die Autoren der Studie hoffen, dass der neu entdeckte Mechanismus neue Ansätze für die Prävention und Therapie bei Krebserkrankungen ermöglichen wird.

http://www.spiegel.de/wissenschaft/medizin/0,1518,796949,00.…

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=424391&pt=…" target="_blank" rel="nofollow ugc noopener">
http://www.investorvillage.com/smbd.asp?mb=971&mn=424391&pt=…

[GuHu1]

Antwort auf Beitrag Nr.: 42.337.697 von GuHu1 am 11.11.11 15:21:58

noch ein versuch....
http://www.investorvillage.com/smbd.asp?mb=971&mn=424391&pt=…" target="_blank" rel="nofollow ugc noopener">
http://www.investorvillage.com/smbd.asp?mb=971&mn=424391&pt=…

[Fruehrentner]

Zitat von GuHu1: noch ein versuch....
http://www.investorvillage.com/smbd.asp?mb=971&mn=424391&pt=…" target="_blank" rel="nofollow ugc noopener">
http://www.investorvillage.com/smbd.asp?mb=971&mn=424391&pt=…

Fehler: Server nicht gefunden






Der Server unter %3cbr%20 konnte nicht gefunden werden.

[GuHu1]

Antwort auf Beitrag Nr.: 42.337.697 von GuHu1 am 11.11.11 15:21:58

Cancer Vaccines

Yusuke Nakamura, MD, PhD

Professor, Laboratory of Molecular Medicine

Institute of Medical Science

The University of Tokyo

Tokyo, Japan

H&O What are some recent developments in tumor vaccines?

YN The goal of tumor vaccines, a type of immunotherapy, is to stimulate the immune system in order to recognize and eliminate cancer cells. There are various strategies in immunotherapy; some use cancer cells from the patient, some use cancer cell lines, and others use proteins and peptides. Immunotherapy has been viewed as an experimental therapy until very recently.

In April 2010, sipuleucel-T (Provenge, Dendreon) was approved for men with advanced prostate cancer. This regulatory approval provided some proof that immunotherapy could be used for treatment of cancer, and in the next 5–10 years, we expect many therapeutic cancer vaccines to be approved. At present, there are approximately 20 multiple type vaccines (ie, cancer cell-, protein-, and peptide-based vaccines) being investigated in phase III trials. This discussion will focus on peptide-based vaccines.

H&O Why are vaccines an attractive option for cancer treatment?

YN I think there is interest in cancer vaccines as anticancer therapeutics because they have very limited side effects. Although many patients may develop local reactions at the injection site when vaccines are administered subcutaneously or intradermally, systemic reactions are rarely seen. Further, I believe that cancer vaccines will improve quality of life compared to most of the anticancer therapies. At present, an important consideration in cancer treatment is quality-adjusted life years. Generally, oncologists are concerned with overall survival or tumor shrinkage when evaluating drug efficacy; however, it is also important to consider the quality of life of the patient, which may be better with immunotherapy. This is something to keep in mind when developing next generation anti-cancer therapies.

H&O What are the challenges seen in cancer vaccine development?

YN One of the challenges is convincing oncologists of the way to evaluate the effect of cancer vaccines, as it is different from that used to evaluate anti-cancer therapies. During a clinical trial of immunotherapy, even if no tumor shrinkage is observed, this does not mean that the therapy is not effective. It is particularly difficult to convince oncologists of this idea in Japan. Another limitation that is encountered is the need for a longer period of time to see effects of immunotherapy. Because of the time it takes to increase the number of cytotoxic T cells, especially for patients with larger tumors, more time is needed to observe benefit. Considering the kinetics of the activated T cells by vaccine, antitumor effect may take up to several months. In general, early-stage clinical trials for cancer therapies that include vaccine treatment can only enroll patients who have failed previous chemotherapy and who have advanced-stage disease. Because these patients are in advanced disease, their survival is usually not long enough for us to be able to see the effects from vaccination, especially if longer follow-up is necessary.

H&O Is there evidence of synergy between vaccines and chemotherapy?

YN Vaccines and chemotherapy have been administered concurrently to treat cancer, and such combinations are actively being investigated. However, there are some concerns because cytotoxic anticancer drugs naturally cause immunosuppression while the tumor vaccine enhances the immune response. However, many doctors feel that there is some synergistic effect between chemotherapy and cancer vaccine treatment given to patients with good performance status.

Our laboratory is involved in translational research evaluating cancer vaccines in various tumors. In the last 5 years, we have enrolled 1,600 patients; in our analysis of these patients we have seen evidence of synergy between chemotherapy and immunotherapy. Some examples of vaccine and chemotherapy combinations include gemcitabine and vaccination for pancreatic cancer and tegafur-uracil plus vaccination for colon cancer.

H&O At what point should a vaccine be administered?

YN Ideally, we would provide cancer vaccines in the adjuvant setting or even in patients with minimum metastatic disease because the number of the cancer cells is small enough. The number of cancer cells of a 10-cm tumor is estimated to be approximately 1011. It is very difficult to increase the number of vaccine-specific cytotoxic T cells to this level. We should be providing chemotherapy and immunotherapy concurrently in the early stages of disease. If we are to expect a clinical effect of a vaccine as a single therapy, we should try to select a patient population with minimal tumor burden and use overall survival as the endpoint.



H&O What kind of patient population is ideal for vaccines?

YN We have been providing vaccination to patients with very advanced disease after at least 1 regimen of chemotherapy. However, vaccine therapy should ideally be given to patients with minimum metastatic disease or to prevent recurrence in patients who, after a surgical procedure, have no signs of metastasis. Patients with smaller tumors (eg, 1 cm) are expected to have benefit from cancer vaccines because we do not need to increase the large number of T cells as much as we would need to for someone with a tumor that was 10 cm.

H&O What kind of research are you involved with?

YN Recently, we had a meeting of the Cancer Peptide Vaccine Translational Research Network, which is madeup of members from approximately 60 hospitals in Japan. Five
years ago, our members accepted the idea that cancer vaccines could be a viable treatment approach, and our study results from 2 years ago further solidified this possibility. At this year’s meeting, we have presented additional evidence that cancer vaccines will be established as a cancer treatment in the near future. In addition to the research being done by our group, various Japanese companies are running clinical trials of cancer vaccines for pancreatic, bile duct, esophageal, and bladder cancers.

http://www.searchmedica.com/resource.html?rurl=http://www.cl…

[GuHu1]

Antwort auf Beitrag Nr.: 42.337.778 von Fruehrentner am 11.11.11 15:33:45

habs jetzt rauskopiert!

[GuHu1]

na wenn er meint, wollen wir mal sehen... noch muss dndn 2011 einigermaßen anständig beenden.

Charly Travers, Motley Fool Million Dollar Portfolio analyst:
I'm calling Dendreon (Nasdaq: DNDN ) as the comeback stock of 2012. A confluence of factors ranging from management's loss of credibility, slashed Provenge sales guidance, and a slower-than-expected sales ramp has sent this former highflier stock crashing back to Earth. As a one-of-a-kind product for treating prostate cancer, Provenge holds a lot of value, and I expect Dendreon's shares to bounce back.

http://www.fool.com/investing/high-growth/2011/11/11/roundta…

[GuHu1]

Lazard Capital Markets Presentation

Impressions (from memory)
- Schiffman gave a straight forward presentation.
- Many of the slides we have seen before.
- Two visually attractive and informative slides near end of presentation
Commitment to Immunotherapy Research (showing six Provenge-related ongoing trials: PROCEED, Abiraterone-Provenge, DO Phase 2, NeoACT, ProACT, OpenAct; and one Her2/neu trial: NeuACT).
Platform Targets Large Unmet Medical Needs.
- Reiterated strong balance sheet and expectation that current cash resources adequate to achieve cash flow break even in US without needing to access capital markets.
- Affirmed that sites with experience are servicing on average 2 patients per month (as expected), new sites about 0.5 patients per month; will take about 4 - 6 experiences for new sites to reach 2/month.
- Financial guidance withheld until patterns affirmed. Roughly by third quarter next year.
- Excellent response to cost question. Made it clear that cost was not exceptional and that other therapies can/do cost more when doctor visits, treatment of side effects, etc., are factored in.
- Confirmed that current manufacturing utilizes a small percentage of capacity; that unless plant is shuttered for two years or more it is a poor decision to shut plant down.
- Reiterated European filing expected in early 2012.

http://www.investorvillage.com/smbd.asp?mb=971&mn=424662&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.354.126 von GuHu1 am 15.11.11 17:32:46

Hi GuHu,

hab mir den CC reingezogen, war gut, aber DNDN muß mit guten Quartalszahlen das Vertrauen der Investoren zurückgewinnen dann wird`s schon wieder werden,
was für mich zählt: Es gibt in diesem miesen Endstadium von Prostatakrebs kein besseres Produkt als das FDA zugelassene Provenge!
Qualität mit geringem Nebenwirkungen wird sich durchsetzen, Erstattung auch innerhalb von 30 Tagen, was will die Börse mehr? ROW-Partner, es gibt überall auf der Welt reiche prostatakrebskranke Männer die Provenge als Mittel der Wahl nehmen, das muß ein Ziel von Dendreon werden bzw. vom ROW-Partner!

Aber bei den Manipulationen an den Börsen ist nicht einfach wieder herauszukommen aus dem Sumpf von Lug und Betrug!

[Gulliver]

Antwort auf Beitrag Nr.: 42.354.541 von Magnetfeldfredy am 15.11.11 19:01:58

Vielen Dank erstmal für die hochwertige Arbeit hier - seit dem letzten Absturz auf 6,5$ lese ich hier wieder intensiv mit, da die aktuelle Bewertung imho wieder fundamental attraktive Chancen nach oben eröffnet.

Ich bin kein Dendreonjünger, habe aber damals zum Glück rechtzeitig vor der Provenge-Zulassung im Preisbereich 3-5 $ ordentlich DNDN-Calls gesammelt und bin dann nach der Zulassung im Bereich 18-20$ an den ersten 2-3 Handelstagen ausgestiegen.

Imho machen Gold und Kosorten einen sehr guten Job, das Problem ist eher, dass DNDN lange Zeit die letzten 24 Monate "priced for perfection" war - also viel zu teuer und die Erwartungen viel zu hoch, als dass man sie überhaupt erfüllen konnte.

Man darf nicht vergessen - und das kam in einem der hier zuletzt geposteten Artikel sehr gut hervor - Provenge ist immerhin der 8-beste Medikamentenlaunch aller Zeiten - und das durch ein Startup, welches gerade erst alle Strukturen aufbaut.

Eine Glaxo, Roche oder Pfizer haben da natürlich ganz andere Startchancen...

In dem Sinne sehe ich schon einen erheblichen Schritt in der Umsatzentwicklung der letzten 12 Monate.

Jetzt wird es darum gehen mit einem weiteren 50%igen Umsatzwachstum in den USA Richtung Break-Even zu laufen.

Für Q4 ist da nicht mehr viel zu erwarten - aber immerhin wieder 3 Monate wo neue Center aufgenommen werden - und die Doktoren und Patienten weitere Erfahrung mit der gerade erst etablierten Krankenkassenerstattung und der Medikamentengabe machen! Das wird dann in 2012 imho einen Schub geben.

Mich würde es jedenfalls nicht wundern, wenn man ab April, vielleicht auch erst August September bei 40-50 Mio $ Monatzsumsatz angelangt ist. Denn die Lernkurve in der Cancercommunity ist noch recht steil momentan in Bezug auf Provenge...

Bei Break-Even ist die Aktie imho für 14-20$ gut...

cu gulliver

[edelupolino]

Antwort auf Beitrag Nr.: 42.354.541 von Magnetfeldfredy am 15.11.11 19:01:58

Hi Fredy,
Sumpf von Lug und Betrug!

Für mich ist es -trotz aller schlechten Erfahrungen und aller Beweise über gigantische Betrügereien und verbrecherische Kungeleien an den amerikanischen Börsen- immer wieder erstaunlich, wie die US-Behörden es zulassen,dass die Drahtzieher an den Börsen ihr übles Spiel so dreist durchziehen können.

Das angebliche "freie Spiel der Kräfte", das einen (guten) Kapitalismus auszeichnen sollte, ist nichts als ein lächerlicher Spruch, wenn je nach Gusto die eine oder andere Firma (fast) in den Ruin getrieben werden kann, und das Schlimmste:
die Hedgefonds etc nutzen "nur" den Spielraum aus, der ihnen von blinden (oder bestochenen!!) Behörden gelassen wird.
Ciao Ede

[03482]

Antwort auf Beitrag Nr.: 42.355.657 von edelupolino am 15.11.11 22:59:36

Im Aufsatz "Dendreon" von Mark Mitchell kann man lesen, wieviele Betrüger und
Gangster sich im Umkreis der Wall Street tummeln. Ich frage mich nur, wie lange die USA als normaler Staat bestehen wird können ?

[edelupolino]

Antwort auf Beitrag Nr.: 42.355.987 von 03482 am 16.11.11 07:17:52

dito!

Es gab vor Jahren mal nen Staatsanwalt, der Hoffnungsträger für eine bessere, gereinigte Wallstreet war (Spitzer); ein Finanzgangster nach dem anderen fing an zu zittern, weil S. durchgriff und kriminelle Geldgier bestrafte.
Leider fiel S. selbst durch eine andere Gier -und die WSt-Gangster hatten wieder FREIE Fahrt.

[GuHu1]

Antwort auf Beitrag Nr.: 42.355.987 von 03482 am 16.11.11 07:17:52

damit nicht genug......

November 16, 2011
13:14 EDT DNDN
Dendreon resumes trading

13:11 EDT DNDN
Dendreon trading paused for volatility after spiking over 11%

das ist wohl ein witz, oder.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.360.187 von GuHu1 am 16.11.11 20:19:46

Autodesk, Bob Evans Farms, Dendreon, InvenSense, Tyco: U.S. Equity Movers


Q
By Whitney Kisling - Nov 16, 2011 8:41 PM GMT+0100 .




inShare.1

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Shares of the following companies are having unusual moves in U.S. trading. Stock symbols are in parentheses and prices are as of 2:15 p.m. in New York.

Gulf Coast refiners fell on the prospect of less favorable pricing after Enbridge Inc. (ENB) said it would reverse the direction of the Seaway pipeline to eliminate a bottleneck that had lowered the price of West Texas Intermediate versus other oils.

Tesoro Corp. (TSO) slid 6.3 percent to $25.15. Valero Energy Corp. (VLO) declined 6.7 percent to $23.22. HollyFrontier Corp. (HFC US) lost 6.6 percent to $25.75. CVR Energy Inc. (CVI) retreated 14 percent to $18.95.

Abercrombie & Fitch Co. (ANF) fell the most in the Standard & Poor’s 500 Index, slumping 13 percent to $48.38. The teen-clothing retailer reported third-quarter earnings excluding some items of 57 cents a share, missing the average analyst estimate by 20 percent, according to Bloomberg data.

Amtech Systems Inc. (ASYS) dropped 17 percent, the most in the Russell 2000 Index, to $8.58. The maker of products for manufacturing computer chips and solar cells forecast a loss in the first quarter. Analysts in a Bloomberg survey expected a profit.

Autodesk Inc. (ADSK) rose 6.7 percent to $36.31 for the second-biggest advance in the S&P 500. The maker of design software reported third-quarter profit of 44 cents a share, exceeding the 41-cent average analyst estimate.

Bob Evans Farms Inc. (BOBE US) dropped 5.3 percent to $31.92 after losing 7.9 percent earlier for the biggest intraday decline since Feb. 16. The family-restaurant chain owner reported second-quarter earnings that missed the average analyst projection.

Chemed Corp. (CHE) fell 8.5 percent to $52.61 after tumbling 16 percent earlier, the most intraday since April 2008. A hospice-chain unit of the health-care company owner was accused by a former manager of defrauding the federal government by conspiring with health insurers to enroll Medicare patients who weren’t dying, according to a lawsuit unsealed last week in U.S. District Court in Dallas. The unit, Vitas Healthcare Corp., has attracted government scrutiny as its Medicare-covered patients have doubled to 1.1 million over the last decade. Vitas spokeswoman Kal Mistry said the company “cannot comment on pending litigation.”

Dendreon Corp. (DNDN) rose 4.3 percent to $7.52 and rallied 12 percent earlier, the most since Nov. 8. Goldman Sachs Group Inc. held a conference call with a urology expert to discuss the prostate-cancer drug Provenge, which Dendreon makes, according to a source familiar with the situation.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 42.360.358 von Magnetfeldfredy am 16.11.11 20:54:00

Unsere Debbie ist immer für Überraschungen gut, diesesmal sollte mal wieder eine positive news kommen, oder?

[GuHu1]

Antwort auf Beitrag Nr.: 42.360.528 von Magnetfeldfredy am 16.11.11 21:28:12

November 16, 2011

COMMENT
Dendreon Corporation (DNDN) $7.21

Positive takeaways from a call on Provenge with a leading urologist

We hosted a call today with a urologist, who is a leader in the Large Urology Group Practice Associations (LUGPAs; 10+ urologists), to discuss the evolving prostate cancer landscape, with a focus on Provenge. LUGPA represent nearly 20% of the US urologists. We have previously identified the LUGPAs as a key target for potentially increasing Provenge use given they are best equipped, in our view, to use the drug.

http://lugpa.org/default.aspx

Our key takeaway from the call is that the use of Provenge could be expected to significantly accelerate in 2012:

- In the urologist’s view, the CMS National Coverage Determination (NCD) was largely responsible for the limited uptake of Provenge over the past year. In his practice, for example, he was unable to roll out a protocol for Provenge use until November 1, 2011. Since he has rolled out the protocol, his practice has already placed 7 patients on Provenge, and has identified 100-200 eligible patients for the drug as well.

- He also feels that the other LUGPA members are beginning to embrace Provenge. He believes there could be a logarithmic increase in uptake of the drug in 2012.

- He also articulated the need for urologists to embrace Provenge to optimize patient care as they could otherwise risk losing the patients to others who might.

- He sees the risk/reward of Provenge use as compelling. He felt his patient traded in 10 hours of logistics in getting Provenge for a potential 4-month increase in survival with no toxicity (unlike chemotherapy).

Our rating and price target are unchanged.

Sapna Srivastava
Yogesh Ahuj


http://www.investorvillage.com/smbd.asp?mb=971&mn=424811&pt=…

[GuHu1]

Corporate presentations at healthcare conferences conducted by Wall Street financial firms don’t often reveal much that the Street doesn’t already know. So, I didn’t expect Greg Schiffman, Dendreon’s (DNDN) chief financial officer, to reveal much in the way of new information when he made a presentation at the Lazard Healthcare Conference on November 15, 2011.

Importantly, however, near the end of his presentation, Schiffman mentioned that in 2013, the company will initiate a trial with Provenge in earlier stage prostate cancer, a trial for men who are hormonally sensitive (not castrate resistant, but where the disease has metastasized). In particular, he stressed that the placebo arm in this trial would be a true placebo ... that is, one that did not include frozen Provenge, or Frovenge, as it is known. As such, he said, the company anticipated a much higher overall survival, or OS, advantage than what had been observed in the pivotal Provenge trials.

Recall that in the case of the pivotal Phase III Provenge trials, the overall survival advantage was a median of 4.1 months (at 50% survival, 25.8 months in the Provenge arm vs. 21.7 months in the placebo arm). The new study not only would be the first time that the company has run a survival-based trial in an earlier stage of the disease, but also one using a pure placebo. Of and by itself, this is extremely important. But let’s examine further the point regarding his statement that the company anticipated a much higher OS advantage than what was observed in the Provenge trials.

What’s this all about? Well, some readers may recall that in the pivotal Phase III Provenge trials performed to obtain FDA approval, Frovenge - or APC8015F, as it also is known - was given to more than two-thirds (80%, according to Schiffman) of the placebo arm. As concluded by Gomella, et al.* in a 2011 ASCO poster presentation, “(P)ost-progression treatment with APC8015F may have extended survival of subjects, potentially reducing the magnitude of survival difference observed between sipuleucel-T and controls in randomized controlled trials.” Put another way, the life-extension value of Provenge may have been significantly underestimated by the manner in which the trial was designed. (You can view the entire poster here.**)

By how much was it underestimated? Well, inspection of the figure below (Figure 3 on the poster) shows that the segment of the control arm that did not receive Frovenge had a median survival time of 12.7 months while the segment of the control arm that did receive Frovenge had a median survival time of 23.6 months. This implies that the "true" overall median survival advantage to Provenge should be considerably longer if it is determined in a trial for which the control arm is NOT given Frovenge. In fact, one might reasonably argue, on the basis of these data, that the "true" overall, median survival advantage in treating end stage prostate cancer with Provenge should be something on the order of 12.7 months, or more than one year (25.4-12.7=12.7 months).

This might explain on an intuitive level why end stage PCa sufferers such as Eduardo Garcia lived more than nine years after being treated with Provenge (read an interview with Garcia at the six-year mark here), though such an outcome is certainly not outside the realm of statistical probability.

The above notwithstanding, and to play the Devil’s advocate (if I don’t, I’m sure someone else will), the issue with statistics such as these is that, without a bona fide randomized trial, there may be biases in the data that never can be accounted for by any regression analysis.

For example, it isn't difficult to imagine that the patients who did not receive Frovenge in the pivotal Phase III Provenge trials were sicker to begin with, and this may have been the reason doctors hastened them into more aggressive treatments with Taxotere or other treatments. So, it’s logical to assume that those patients would naturally have died earlier compared to the ones who were healthier and could take Frovenge. In turn, that would mean that, to some extent, the analysis cited above might have been comparing healthier and sicker patients and not necessarily treated and untreated patients.

If this were the case - that is, the study was biased by the treatment given to the sicker patients - then the analysis performed by Gomella, et al. would be suspect. Regardless, I believe the trend observed by the authors is real but the benefits may not be of the magnitude cited. Perhaps there’s another way to estimate what the median survival time for a pure placebo group such as what might be found in a trial such as that Dendreon is about to undertake.

The pivotal Phase III Taxotere trial (here) used to obtain FDA approval for that treatment had median survival times of 16.5 and 18.9 months for the placebo and treatment arms, respectively. If we take the 16.5-month median survival time for placebo patients and compare it with the 25.8-month median survival time for treated patients in Dendreon’s IMPACT trial, we obtain something on the order of a nine-month median life extension difference. This still is a little over twice the 4.1-month median life extension difference upon which Provenge was approved, but clearly shorter than the 12.7 month median life extension difference suggested by the data of Gomella, et al. Regardless, what’s important is the fact that the true median life extension measure for Provenge, measured against a pure placebo, almost certainly is well in excess of the 4.1 months upon which FDA approval was based.

The inescapable conclusion is that the Phase III trial designs almost "did in" the results of the trails and put the approval of Dendreon’s revolutionary immunotherapeutic treatment "at risk." As David Miller of Biotech Stock Research would say, “The trials (almost) failed the drug.” That said, however, a reviewer of this article prior to submission noted that Frovenge was allowed because (1) the early trial design was focused on obtaining approval on progression, not survival (the former being faster and less expensive), and (2) the availability of Frovenge was seen as an inducement for getting patients enrolled quickly. That is, they would get some treatment, regardless of how they were randomized. Remember, when Dendreon began running its Phase III trials, Taxotere had not yet been approved either.

Another interesting piece of information gleaned from Schiffman’s presentation included the fact that the corporation intends to initiate a randomized, Phase II sequencing study involving Provenge and abiraterone acetate (Zytiga; from Johnson & Johnson (JNJ)) in 2013. The study, for which the protocol already has been approved, will involve 60 patients and roughly 15 sites. Co-medication has been long recognized as a viable means by which to enhance the treatment regime for various diseases (e.g., AIDS/HIV). It should be no different when it comes to prostate cancer.

The co-medication trial involving Provenge and Zytiga will comprise two parts: One in which the two treatments are given simultaneously and one in which Zytiga is given 60 days following the last infusion of Provenge. Why this protocol?

The co-application of Provenge and Zytiga, and the order in which the two should be given, raises interesting questions. In the asymptomatic/minimally symptomatic mCRPC setting for which Provenge is indicated, the National Comprehensive Cancer Network, or NCCN (NCCN; log-in required), has given Provenge a category 1 rating, the highest evidence level recommendation based upon its three Phase III clinical trials. By contrast, and in Provenge’s "space" - the asymptomatic/minimally symptomatic mCRPC setting - Zytiga has a category 2B rating, the second lowest rating, based upon small single arm Phase II trials. This has not stopped some physicians from prescribing Zytiga off-label to PCa sufferers in an estimated 22% of cases where patients probably should be treated with Provenge first. Current thinking is that prescribing Zytiga first will delay medication with Provenge. The reason for this stems from the belief that if Zytiga is given first, a patient’s system must first be cleansed of prednisone before Provenge can be given, something that can take at least 60 days.

The issue of sequencing Provenge and Zytiga also has been addressed by Eric Small in the Journal of Clinical Oncology. Small writes: “The practical dilemma of the appropriate sequence of use of the two new noncytotoxic agents (sipuleucel-T and abiraterone) is being addressed by trials that are under development. For now, given the broader window of applicability of abiraterone and the longer time required to develop an immune response with sipuleucel-T, if both agents are to be used, it seems reasonable to administer sipuleucel-T first with abiraterone after additional disease progression. Biomarkers to help define the optimal use of immunotherapy are needed.”

Given the above, we now see why one segment of Dendreon’s new co-medication trial will delay treatment with Zytiga by two months; that is, for the purpose of determining the impact of the time delay on the efficacy of the combined treatment.

Regardless, given its NCCN No. 1 rating and the recommendation of the Journal of Clinical Oncology, Provenge appears to be the "foundation of care" upon which oncologists and urologists can confidently build a "best practice" treatment regime in the asymptomatic/minimally symptomatic mCRPC setting.

Technical Analysis

Dendreon jumped on Wednesday, November 16 - in fact, the stock was halted for a brief period - after a leader in the Large Urology Group Practice Association, a 10-year-old organization that represent nearly 25% of U.S. urologists, said in a Goldman Sachs conference call that his practice has already placed seven patients on Provenge and has identified 100-200 eligible patients for the drug as well. Further, this practitioner said it was his belief there could be a logarithmic (perhaps "exponential" is a more familiar term (Cohen)) increase in uptake of the drug in 2012 and that there was a need for urologists to embrace Provenge to optimize patient care as they could otherwise risk losing the patients to others who might provide the treatment. The stock immediately jumped to more than $8, was halted, and upon reopening, drifted down to close at $7.51 Wednesday afternoon. The stock closed above $8 on Thursday.

An alternative explanation for the sharp jump in share price on Wednesday, interestingly enough, appeared in the comments section that can be found at the end of an article I wrote earlier this month (Dendreon, Merck's Hepatitis C Drug: Future Prospects Look Encouraging). The comment of interest, written by a poster using the pen name "slowtime," posits that the run to $8+ in the stock’s price on Wednesday was instigated by a major buyer who triggered a short squeeze of sorts. Whatever the reason, it once again shows that DNDN is volatile, and surprises are more the rule than the exception.

The daily chart, courtesy StockChart.com, is below. It shows the issue rising in relative strength and continuing to climb back toward the 50-day moving average. The weekly chart is more encouraging, showing the stock coming out of its oversold condition, with the MACD about to turn positive.

Finally, as noted by Adam Feuerstein, several major hedge funds have reduced or sold their entire positions in Dendreon, including Cohen's SAC Capital Advisors, which dumped 8.3 million shares during the third quarter. However, noted Feuerstein, "Baker Brothers Advisors gobbled up 2.6 million shares during the September quarter. Camber Capital Management also initiated a new Dendreon position with a 2 million-share purchase." Other hedge fund buyers were cited as well.

*L. G. Gomella, C. Nabhan, J. B. Whitmore, M. W. Frohlich, D. J. George; The Kimmel Cancer Center at Jefferson, Philadelphia, PA; Advocate Lutheran General Hospital and Oncology Specialists, S. C., Park Ridge, IL; Dendreon Corporation, Seattle, WA; Duke Cancer Institute, Durham, NC

**Reproduced with the permission of Dr. L. G. Gomella, personal communication, November 17, 2011

http://seekingalpha.com/article/308914-dendreon-new-trial-to…

[keyar]

was mir seit einiger zeit durch den kopf geht ist die frage,
warum jetzt, wo dndn recht gut kalkulierbar geworden ist,
immer noch keiner der grossen ein übernahmeangebot rauslegt.
( bei kursen um $ 50 hab ich's noch verstanden, aber jetzt,
wo man mit $ 20 wohl schon bis hart an die squeeze out schwelle einsammeln könnte ?? )

hat da jemand eine plausible erklärung parat ?