Dendreon...mit Provenge das erste Vaccin zur Krebstherapie? - 500 Beiträge pro Seite (Seite 11)

[GuHu1]

huckman at seekingalpha

http://seekingalpha.com/article/67390-fda-turns-over-dendreo…

[GuHu1]

Antwort auf Beitrag Nr.: 33.573.970 von GuHu1 am 06.03.08 23:06:43

@hakur
document1 und document2 beinhalten die E-Mails von denen Atech sprach.

[edelupolino]

im moment leider unter 5$...

[surga]

Antwort auf Beitrag Nr.: 33.580.548 von edelupolino am 07.03.08 16:37:27

ja, leider

[hakur]

wie Ihr an dem fallenden roten Keil im letzten Chart sehen könnt ist noch Luft nach unten ohne dass was anbrennt. Bis ca 4.89
Dndn wird durch gewisse Kräfte bis auf das Äusserste manipuliert.
Dndn hat keinen Partner der Schutz bieten könnte.Ist meine Meinung und wie schon erwähnt setzen die Shorts dieser Aktie übel zu.
Kopiere hier einen Satz von A-Tech/ IV board rein.
"The big problem is that our short interest has a habbit of breaking technical indicators at will--they are professional market technicians, after all."

Bin von diesem Chart ganz schön angenervt,würde aber sagen dass eine Trendwende ansteht.

immer noch loong

[hakur]

Antwort auf Beitrag Nr.: 33.581.037 von hakur am 07.03.08 17:18:57

Autsch da sind die 4.88 auch schon.

[hakur]

Antwort auf Beitrag Nr.: 33.581.063 von hakur am 07.03.08 17:21:08

Naja close war auf der entscheidenten Linie,- Unterseite des fallenden roten Keils. Angekratzt ist er.
Theoretisch noch maximale 3 Handelstage bis in die Spitze, dann sollte diser sich auflösen.

so loong

[GuHu1]

Antwort auf Beitrag Nr.: 33.584.649 von hakur am 07.03.08 22:25:34

hi hakur,
danke für deine mutigen analysen, ich weiß das du sonst sehr vorsichtig mit einschätzungen bist.
wer von den investierten ist nicht vom chart angenervt?

nicht vergessen, 50:50.

[edelupolino]

Antwort auf Beitrag Nr.: 33.585.339 von GuHu1 am 07.03.08 23:38:02

...diese 50:50 sind immer noch besser als lotto zu spielen...

Es wäre nur zu toppen, wenn wir in dem team säßen, das die versuchsreihe durchführt...leider kenn ich da keinen, der etwas ausplaudern könnte...

[GuHu1]

http://www.ustoo.org/PDFs/HotSheets/HotSheet032008.pdf

[Mr.Perfect]

Antwort auf Beitrag Nr.: 33.592.073 von GuHu1 am 09.03.08 15:10:50

so gesehen müsste da was seitens FDA kommen. evtl. schon diese woche??

[GuHu1]

Antwort auf Beitrag Nr.: 33.593.183 von Mr.Perfect am 09.03.08 20:20:50

warum sollte sich die fda bewegen? was soll da kommen.

[GuHu1]

huuu, ob da der eine oder andere ins schwitzen kommt, eher nicht oder?

FBI reportedly investigating Countrywide
Nation’s largest mortgage lender may have lied about risk of loans

http://www.msnbc.msn.com/id/23547847/

[edelupolino]

Antwort auf Beitrag Nr.: 33.593.624 von GuHu1 am 09.03.08 22:36:40

die FBI-jungs und mädels sollten mal die finanzströme auf Schers konten genau analyieren:

wär bestimmt aufschlussreich...so oder so!

[GuHu1]

schlusskurs $4,90 bei dem schlechten marktumfeld und ein neuer job bei dndn.

Environmental Health & Safety Specialist
Human Resources Coordinator (long term temp)
Regulatory Technical Writer (long term contract)
Sr. Accounts Payable Specialist (temp)
Sr. QA Associate Quality Systems neu 10.03.08
Sr. Quality Computer Validation Specialist

[hakur]

Antwort auf Beitrag Nr.: 33.603.051 von GuHu1 am 10.03.08 22:27:42

ja guhu die 4.90 waren schon ein Lichtblick in dieser schwarzen Nacht
Der chart verlangt nach einer Entscheidung, der rote kleine fallende Keil innerhalb des großen grünen Keiles ist fast in der Spitze gefüllt.
Bin bei Dndn inzwischen vorsichtig geworden mit Prognosen , schaut Euch den Chart selbst an und zieht eigene Schlüsse daraus.
Für mich habe ich eine Idee...

so loong

[GuHu1]

danke für den chart hakur.

[edelupolino]

Antwort auf Beitrag Nr.: 33.603.294 von hakur am 10.03.08 23:03:49

absolut schön anzusehen -diese keile...mal sehen, wo sie verlassen werden.

[Mr.Perfect]

nun, dndn kratzt am unteren BB. mal schauen, evtl. könnte dndn dieses band durchbrechen und bis in den bereich 4,4$ laufen...

c-ya
mr.perfect

[hakur]

Antwort auf Beitrag Nr.: 33.612.281 von Mr.Perfect am 11.03.08 19:03:32

@ Mr.perfect-
dndn kratzt am unteren BB. mal schauen, evtl. könnte dndn dieses band durchbrechen und bis in den bereich 4,4$ laufen

Wollen wir mal nicht hoffen, sieht nach dem heutigen Verlauf auch nicht so aus.
Bin vorsichtig positiv gestimmt.
so loong

[GuHu1]

Settlement Date: 02/29/2008
Short Interest: 34,965,949
Percent Change: 4.72
Average Daily Share Volume: 1,716,558
Days to Cover: 20.37

http://www.nasdaqtrader.com/trader.aspx?id=ShortInterest

[surga]

Antwort auf Beitrag Nr.: 33.613.648 von hakur am 11.03.08 20:57:03

das will ich auch nicht hoffen
Charmäßig von gestern sah nach Harami Cross aus, wo der Boden schon gefunden wurde

[GuHu1]

Antwort auf Beitrag Nr.: 33.603.294 von hakur am 10.03.08 23:03:49

nun ja $4,93, die lage spitzt sich zu, ums mal auf den chart zu beziehen.

[hakur]

Antwort auf Beitrag Nr.: 33.614.487 von GuHu1 am 11.03.08 22:16:05

yes it is
eigentk#lich schon nach norden ausgebrochen, braucht aber noch eine Bestätigung!

[LaPlue]

FDA Agrees to Amend Dendreon's Special Protocol Assessment for Phase 3 IMPACT Study of PROVENGE -- Amended Agreement Accelerates Expected Timing of Final Analysis by One Year While Maintaining Comparable Powering of Interim and Final Results -- - Dendreon to Hold Conference Call on Thursday, March 13, 2008 at 11:00 AM ET - SEATTLE, WA, March 12, 2008 - Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) has agreed to an amended Special Protocol Assessment (SPA) for the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE(R) (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. In addition, the FDA has reconfirmed that they would accept a positive interim or final analysis from the IMPACT trial to amend the Biologics License Application (BLA) for licensure of PROVENGE. The amended SPA accelerates the expected timing of the final IMPACT results by approximately one year while maintaining comparable powering of the study's interim and final results. By increasing the number of events and decreasing the alpha (false positive error) spending function for the interim analysis, the Company is able to reduce the number of events for the final analysis (from 360 to 304) and still maintain a comparable statistical power for both the interim and final analyses. Interim results are still expected in the second half of 2008; however, final results are now expected in the second half of 2009 rather than 2010. Based on the statistical plan in the amended SPA, if the treatment effect at the interim analysis for the IMPACT trial is consistent with the integrated results of the previous two completed phase 3 studies (D9901 and D9902A), Dendreon would expect to achieve the pre-specified criterion for significance and would amend the BLA submission with the FDA based on these interim results. "The amendment of the SPA allows us to accelerate the expected timing of our final results by a year while maintaining comparable power for the study," said Mitchell H. Gold, president and chief executive officer of Dendreon. "Our commitment to helping patients with prostate cancer is unwavering, and we remain focused on providing the necessary data to the FDA as quickly as possible to enable us to bring PROVENGE to the men in need of a new treatment option." Conference Call Information Dendreon will host a conference call tomorrow at 8:00 a.m. PT, 11:00 a.m. ET. To access the live call, dial 1-877-548-7901 (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 recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-888-203-1112 or [phone] for international callers; the conference ID number is 5074038. The replay will be available from 7:30 pm ET on Thursday, March 13 until 11:59 pm ET on Saturday, March 15. In addition the webcast will be archived for on-demand listening for 30 days at www.dendreon.com. About IMPACT Study DesignThe IMPACT trial is a randomized, double blind, placebo controlled Phase 3 study, which enrolled just over 500 men with metastatic, androgen independent prostate cancer with a primary endpoint of overall survival. About Prostate Cancer Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases expected to be diagnosed in 2008, and approximately 28,660 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic prostate cancer. About Active Cellular Immunotherapy with PROVENGEPROVENGE may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. In clinical studies, patients typically received three doses of PROVENGE over a one-month period as a complete course of therapy. About DendreonDendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. 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. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has its headquarters 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 www.dendreon.com. Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that theFDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further 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. Contact Information: Jennifer WilliamsInvestor RelationsDendreon Corporation206-829-1500 Katherine StuelandWeissComm Partners(312) 208-0320

[Birgit.Tersteegen]

Glückwunsch zu den news,Jungs!

[NoSelters]

Antwort auf Beitrag Nr.: 33.618.789 von Birgit.Tersteegen am 12.03.08 13:08:35

Chapeau....

No

[Mr.Perfect]

könnte nun einen schönen run auf die 6$ geben oder was meint ihr??

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 33.619.142 von Mr.Perfect am 12.03.08 13:42:24

Vor ca. 1 Jahr startete die Ralley bis auf ca. 18 EUR, hätte nichts dagegen wenns wieder passiert, die News zeigen die Dringlichkeit alternativer Behandlungsformen für Prostatakrebs zu befürworten!
Hoffentlich gehts gut!

[Mr.Perfect]

Antwort auf Beitrag Nr.: 33.619.356 von Magnetfeldfredy am 12.03.08 14:00:26

nun, sofern das marktumfeld gut ist kann ich mir einen 3-day run gut vorstellen.
wobei, so einen richtigen 3-day run... gibt es das noch??

lassen wir mal den heutigen verlauf kommen und sehen wie's läuft.
dndn ist vollgepumpt mit shorts,... wird ein heftiger kampf!!

c-ya
mr.perfect

[Poppholz]

dafür, dass die Nachricht so gut ist, passiert bei uns an der Börse recht wenig.

[Mr.Perfect]

Antwort auf Beitrag Nr.: 33.620.188 von Poppholz am 12.03.08 15:04:48

zss, dndn ist ein ami wert. da brauchst du nicht nach D zu gucken.

[edelupolino]

die bestätigung des ausbruchs scheint zu beginnen (5,33$)...mal sehen, wie's die shorts drehen und abwehren können.

[edelupolino]

für die laien wie mich leichtere kost:

Dendreon and FDA Bump Up Trial Timeline
FDA Agrees to Accelerate Dendreon's Timeline for Its Late-Stage Clincial Trial of Provenge
March 12, 2008: 09:52 AM EST
NEW YORK (Associated Press) - Dendreon Corp. said Wednesday the Food and Drug Administration agreed to an accelerated timeline for its late-stage clinical trial of Provenge, the biotechnology company's prostate cancer treatment candidate.

The FDA agreed to amend its special protocol assessment with the new timeline. An SPA agreement generally reduces the risks involved in developing a drug because the drug maker and the FDA agree ahead of time on how the trial will be conducted, and what will be considered proof that the drug works.

The amended SPA speeds the expected timing of the final results by about one year to the second half of 2009. Interim results are still expected in the second half of 2008.

Ciao everybody und
viel spaß noch, shorts!!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 33.621.801 von edelupolino am 12.03.08 16:53:18

Hört sich gut an, außerdem hat jeder Prostatakrebserkrankte die Chance mit der Immunaktivierung durch Provenge verdient, nur meine Meinung!
Bei Zulassung Win-Win Situation für Kranke und uns Aktionäre!

Jetzt heißt`s Daumen drücken!

[edelupolino]

Antwort auf Beitrag Nr.: 33.622.308 von Magnetfeldfredy am 12.03.08 17:29:00

genau!!

und dazu noch dies (aus IV,heute)

another nail in the shorts coffin
Every week the news just gets better. UBS their friendly broker just turned on the shorts with a vengeance and bought over 5 million shares. The proof that CD54 upregulation correlates into extended survival, Two large hedge funds buying over 15 million shares and now the FDA making concessions cutting the length of 9002b approx 1 year. Now the large institutions and hedge funds are fully invested the FDA is preparing the way for early approval, it will not take long for the last nail to be pounded which will seal the casket shut.

[surga]

http://www.cnbc.com/id/23591481/site/14081545?__source=yahoo…

A SPA Break For Dendreon
Posted By:Mike Huckman
Topics:Stock Market | Medicine | Corporate News | CEOs and CFOs | Pharmaceuticals
Sectors:Insurance | Health Care | Pharmaceuticals
Companies Dendreon Corp

Everyone's favorite small-cap biotech put out a press release this morning, announcing that the Food and Drug Administration has agreed to change the Special Protocol Assessment (SPA) for Dendreon's Provenge.

What's a SPA?
It's FDA-speak for the groundrules for a clinical trial -- i.e., here's the stated goal(s) for the study, here are the criteria on which the agency might consider approving the drug, etc. Provenge is an experimental therapeutic vaccine for prostate cancer.

As anyone who follows Dendreon knows, this is a very volatile stock
Dendreon Corp DNDN 5.4 0.47 +9.53% NASDAQ
Quote | Chart | News | Profile [DNDN 5.4 0.47 (+9.53%) ] and there's a big short interest -- investors who think Provenge either doesn't work and/or won't get approved and that the stock will go down.

While the press release repeats a previously stated agreement that the agency might approve the drug based on an interim analysis of clinical trial data expected to be available later this year, it does offer at least one piece of news.

The statement has a lot of clinical trial jargon that the layperson probably can't understand.

I love this one: "By increasing the number of events and decreasing the alpha (false positive errors) spending function for the interim analysis, the Company is able to reduce the number of events for the final analysis (from 360 to 304) and still maintain a comparable statistical power for both the interim and final analysis."

The upshot, according to Dendreon CEO Dr. Mitchell Gold, is that the final test results could be available a year earlier than had been expected. So, the numbers could be available in the second half of next year instead of the second half of 2010.

Investors in biotechs -- especially ones that don't have any products on the market yet -- are placing bets on the future and so any potential acceleration of a drug development pipeline is usually warmly greeted.

Dendreon's holding a conference call tomorrow, Thursday March 13, at 11am ET. If they say anything newsworthy, I'll update the blog.

[GuHu1]

http://www.forbes.com/markets/economy/2008/03/12/dendreon-pr…

[NoSelters]

Ich denke das heutige Gap wird auch wieder geschlossen...
Oder..?

No

[edelupolino]

Author: optimistic skeptic (IV, heute)

I'm going to go out on a limb here and trust that DNDN has had several top biostat scientists analyze and evaluate this carefully before changing the final look and tweaking the interim. I'll also go so far as to speculate that DNDN knows enough about Provenge and the 9902b trial that they believe they have a good chance of garnering an approval either with the interim or the final.



...im IV-thread wird wieder wild gemutmaßt!....aber wenn Gold etc sooo gute experten haben, warum kaufen sie dann nicht wie wild?!?

[Uptick08]

An FDA advisory panel recommended approving the the drug in March, and Dendreon's stock tripled.....


But the agency withheld its approval in May and the stock tumbled

Aber sie wagen es nicht das "denial spiel" zu wiederholen diesesmal, der FDA spielt mit Provenge ein sehr gefährliches Spiel, nun schaut die breite öffentlickeit genau hin sogar welche stocks sie alle im Depot halten

Es könnte wieder auf den alten ATH's gehen in kürzeste Zeit, die FDA hat mit deren Meldung bekannt gemacht das sie letztens voll daneben lag, der nächste Verdreifachung steht uns bald wieder ins Haus (all of this being of course in my very won humble personal opinion)

Good trades & steady hands mit DNDN

[Poppholz]

Antwort auf Beitrag Nr.: 33.624.567 von NoSelters am 12.03.08 20:45:15

wenn ich mir den Kursverlauf der letzten Wochen anschaue und dann die Gegenbewegung, die generell an den Börsen statt gefunden hat, dann ist die Reaktion auf die "gute" Nachricht wirklich bescheiden.



Bin seit langem in DNDN investiert (schon vor dem großen Ausbruch nach oben) habe aber auch immer mal wieder nachgelegt. Somit nur noch knapp im Plus.

Werde die Aktien auch weiter halten, da ich langfristig von einer Zulassung ausgehe.

[edelupolino]

Antwort auf Beitrag Nr.: 33.625.945 von Poppholz am 13.03.08 04:03:30

kaufst du noch weiter oder wartest du auf stärkere charttechnik?
...oder bessere nachrichten?

Ich finde übrigens wie viele im IV-thread, dass durch die motivierte US-öffentlichkeit (kranke, angehörige, senatoren...) die Schers etc genauer beobachtet werden als letztes jahr. ich glaube sogar, sie haben ein gewisses m-sausen...

[GuHu1]

im großen und ganzen ist das echo auf das cc recht positiv.
selbst der viel kritisierten ceo wird NICHT zerrissen, das ist doch mal ne wende um 180° im IV.

kommentar "ocyan":

Quick comments
1. The power for the final analysis went from slightly above 90% to about 88% by the reduction of the trigger from 360 to 304 while the power for the interim went up somewhat. This answers last night questions on "comparable". They were confident of the power estimates even though the very slight downward change in power for the final would normally be inconsistent with the relatively large trigger reduction assuming treatment effect like D9901+02a.

2. Dr. Gold said that they did a Halabi nomogram analysis of the IMPACT cohort and found that to be largely consistent with D9901! If that was not just a slip of the tongue (ie, if it was not the case that he meant D9901+02a instead), that is very nice and would go along way toward explaining why the large reduction of patients at the end of survival curves did not change the power of the trial much. That is, they have improved their assumptions from just integrated D9901+02a data to something slightly better. If this is justifiable, great. If this is just being optimistic, not so great. FWIW, I am inclined to believe this since the GS<=7 population in IMPACT should be comparable to or better than the percentage seen in D9901.

3. It's really too bad that a question that I really wanted to hear an answer to was cut off because the questioner lost connection (must've been a conspiracy of sort :-grr). That question was about whether they used an alpha spending function and how that bears on the interim alpha. In any case, the power of the interim could have gone up because they have significantly raised the interim trigger and only slightly decreased the alpha or it could be the OBF-like phenomenon that we discussed yesterday. The latter would give a much bigger bang for the buck so to speak. But, again, without trigger and alpha, it is hard to tell what the actual chance of success is for the interim.

4. It's good that they will start an adjuvant trial with Provenge before RP. Collecting tissues from that experiment will go along way toward understanding the MOA of Provenge. There is also a boosting procedure for that. Should be an interesting trial to follow. Starting two new trials on Provenge means that they are confident of its eventual approval. The starting of the second trial and when it is expected to finish enrollment may say something about the approval date.

[GuHu1]

http://www.prostate-cancer.org/resource/pdf/Is11-1.pdf

http://seattlepi.nwsource.com/business/354775_dendreon13.htm…

http://joemamasfreepress.blogspot.com/2008/02/visium-asset-m…

http://www.fool.com/investing/high-growth/2008/03/13/dendreo…

[edelupolino]

Antwort auf Beitrag Nr.: 33.636.382 von GuHu1 am 13.03.08 22:09:26

aus dem "Fool"-bericht:

The downside to taking an interim look at a study's data is that the hurdle at the interim for showing positive efficacy is higher than at the end of the study. Dendreon has never revealed this interim overall survival data hurdle, but if the FDA has treated Provenge like it has other cancer drugs, such as GPC Biotech's (Nasdaq: GPCB) cancer compound last year, it's likely high.

...das klingt nicht sehr berauschend -aber naja, der kurs steigt in Fft etwas...

[GuHu1]

Antwort auf Beitrag Nr.: 33.639.512 von edelupolino am 14.03.08 11:18:24

sicher ede, aber verglichen zu den vorherigen äusserungen aus der ecke ist das schon eher neutral. was sollen die auch schreiben.
durch die blume sagen sie das sie keinen schimmer haben.

ob man die situation von dndn heute gegenüber gpc damals vergleichen kann...??

da positioniert sich ubs schon eindeutig, weiterhin sell.

[edelupolino]

Antwort auf Beitrag Nr.: 33.643.946 von GuHu1 am 14.03.08 16:24:40

hab vor ca 3-4 tagen bei IV gelesen, ubs (oder andere schweizer??) hätten gekauft...Bin mir leider nicht sicher...ich weiß nur noch, wie erstaunt ich war.

[GuHu1]

Antwort auf Beitrag Nr.: 33.645.532 von edelupolino am 14.03.08 18:26:40

http://biz.yahoo.com/ap/080314/dendreon_mover.html?v=1

Dendreon Slides on Provenge Questions
Friday March 14, 2:16 pm ET
Dendreon Stock Falls As Wall Street Wonders if Trial of Provenge Vaccine Can Succeed

NEW YORK (AP) -- Shares of drug maker Dendreon are falling as analysts say they doubt the company's prostate-cancer vaccine will be a success.
On Thursday, the Seattle-based company said the Food and Drug Administration is allowing it to speed up a trial of the vaccine called Provenge. Dendreon expects to report initial results later this year, and the FDA said it could approve the drug for sale based on the early data, if it is strong enough.

But analysts still doubted Dendreon Corp.'s chances for success. Jonathan Aschoff of Brean Murray said he thinks the trial will fail, while other analysts suggested the initial results won't be enough for approval or that Provenge will lose out to other vaccines, like Cell Genesys' GVAX.

The stock fell 38 cents, or 7.6 percent, to $4.69.

woher nehmen diese ars..lö..er ihre überzeugung?
die wissen nichts, rein gar nichts, ich im übrigen auch nicht.
ich töne aber auch nicht rum und schreie kaufen kaufen.

[Marchella]

UBS AG stuft DENDREON CORP. auf sell



Rating-Update:

Zürich (aktiencheck.de AG) - Die Analysten der UBS stufen die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) unverändert mit "sell" ein. Das Kursziel werde von 4,50 auf 4,00 USD gesenkt. (14.03.2008/ac/a/u)
Analyse-Datum: 14.03.2008

Rating: sell
Analyst: UBS AG
DENDREON CORP.

[GuHu1]

casystarman IV:

About the New Jersey facility.(making clear the CC meanings)
In speaking yesterday about the New Jersey facility, Dr. Gold used two words that left unclear his exact meaning.

Those words were "ramp-up" and "validate"

I spoke this morning with Mr. Schiffman. When asked for clarification as to the intended meanings, he took time to explain. I received permission to share these explanations publicly.

1. Throughout 2007, the plant was quite busy attending needs imposed by the 9902b Trial. But in November, the plant went back into a "maintenance mode" as work levels dropped off dramatically as a consequence of the completion of enrollment on 8/31/07.

2. It had been "validated" (by FDA inspectors) for Production in January 2007 (or earlier). (You perhaps recall that in the Fall of 2006 Jersey and others monitored unusually heavy activity at the plant—which a guard told jersey had something to do with an FDA inspection, as I now recall.)

3. Processing of patient's blood cells had been shifted from the Mayo Clinic and Seattle (and maybe elsewhere) to New Jersey at that inspection time or shortly after. This was done soon after the plant had been "validated." Gold told us yesterday that the plant in 2007 achieved a high level of activity—the most processing in any given period that the company had ever done. The meaning of those words was simply that, with the plant available for use, the company had taken over all the processing just as the 9902b Trial was enrolling at its maximum rate. He was telling us that the plant performed very well and had demonstrated an ability to deal with volumes larger than the company ever had experienced before.

4. The now infamous CMC 483 inspection in January 2007 had nothing to do with this "validation." I understood him to say that those January 2007 additional inspections were something apart that in no way interfered with the production levels achieved throughout the year in 2007. Further, Dr, Gold was telling us that they also had in no way interfered with our existing prior "validation," IMO, when he stated that the plant is now (and has been) fully "validated" for Production. In other words, those words of his had nothing to do with the 483s.

5. But it is important here to discuss—and this is me speaking now—what is going on at the plant right now in March 2008. It has been minimally occupied and in most businesses, would have been "shuttered" for a few months to save money. This, of course, has not been done, and, in fact, could not be done without costing the company as much as a year or more to re-start and re-validate it. This is an important point. I have written before that it is like restarting an oil refinery once it has been mothballed. So Gold and Schiffman were telling us yesterday that the plant is being maintained "at the ready" despite that this is a costly proposition. It simply would be more costly in delay when the company could least afford delay, if they had retreated to the production elsewhere while the New Jersey plant lay fallow. So the plant remains fully "validated" to avoid re-validation.

Why are they telling us this? Because they wished to convey that we remain "at the ready" awaiting the Interim and, hopefully, an opportunity to swing into production a few mnonths later. It bespeaks confidence in the near-term outcomes in my opnion.
________
As to the reference to "ramp-up" of the plant later this year, it apparently was a reference to the work required on the new Provenge Trials to be launched this spring, and was not a reference to expanding plant capacity except for the additions of employees necessary to handle the new Trials.

[edelupolino]

Antwort auf Beitrag Nr.: 33.646.628 von GuHu1 am 14.03.08 19:49:21

Das irre ist, dass der Asshoff als "finanzjournalist" dauernd eine riesige plattform hat,um sich und seine lügen zu verbreiten -wir als engagierte aktionäre können nichts tun; sogar im IV-thread haben sie keinen "Marsch zur FDA" hingekriegt.

Assh. und die Schers dieser welt manipulieren, wie sie wollen;
sie werden auch die ersten sein, die durch ihre beziehungen (+$$) infos bekommen, wenn der weg von Dndn nach oben zieht...,während sie am tag vorher noch "SELL SELL" schreien, um billig reinzukommen!

[GuHu1]

Antwort auf Beitrag Nr.: 33.648.026 von edelupolino am 14.03.08 22:18:21

nun ja ede, lass sie schreiben, fakt ist das nächste ziel sind die interims daten mitte 2008. hier muss zumindest ein aha effekt die vorherigen studienergebnisse untermauern.

sie werden auch die ersten sein, die durch ihre beziehungen (+$$) infos bekommen, wenn der weg von Dndn nach oben zieht...,während sie am tag vorher noch "SELL SELL" schreien, um billig reinzukommen!

ich denke diesmal werden sie es unweit schwerer haben, zuviele augen sind auf sie und dndn gerichtet, dank der aktivitäten im IV.

ocyan IV:

GS<=7 and trial progress
When D9902b was morphed into IMPACT in late 2005, about 150 patients with GS<= 7 were already enrolled. In the D9901+02a population, about 60% of patients were GS<=7. Assuming that the inclusion of minimal pains might make this percentage drop a bit, say to 55%. That would still mean that of the remaining 350 to be enrolled after the switch of protocols, there would be about 192 patients with GS<=7. So the total of GS<=7 in IMPACT is about 342 or 68% of the entire enrollment population. That's a much higher percentage than D9901 alone or D9901+02a.

The above is an indication that the patients enrolled in IMPACT are relatively healthier than the integrated D9901+D9902a, in fact, better than D9901 itself. Provenge works best on healthier patients as seen in the highly stat sig GS<=7 TTP data in D9901. This is an indication of what Dendreon might see in their prognostic data. By now, they have the blended death events from both arms of the trial and many patients have been on the trial for more than 3 years. They can compare that blended death rates to the blended death rates for either D9901 alone or D9901+02a to see trends. Yesterday, I heard Dr. Gold said that the data were tracking D9901 not D9901+02a. If that is true, it isn't a surprise that they would try to revise the goals for the interim and final looks. Something to think about.

[GuHu1]

Antwort auf Beitrag Nr.: 33.646.985 von Marchella am 14.03.08 20:16:37

hi marchella,
die ansicht vertritt ubs seit ca. 3 jahren, auf die eine oder andere art auch long.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 33.648.530 von GuHu1 am 14.03.08 23:59:49

Also ich sehe daß weiter so, die Chancen für die Zulassung bestehen weiterhin zu
50 Prozent, vor und nach deren Bericht!
Haben wir Glück, Volltreffer, bei Nichtzulassung von US Dollar 4,50 kanns nicht mehr weit nach unten gehen, außerdem haben diese Superanalysten ein Kursziel von US Dollar 4 angegeben, also auch bei Nichtzulassung denn DNDN hat ja noch mehrere Projekte in der Pipline!
I stay long and strong!

[StaatsKnecht]

Antwort auf Beitrag Nr.: 33.649.196 von Magnetfeldfredy am 15.03.08 09:47:44

"Haben wir Glück, Volltreffer, bei Nichtzulassung von US Dollar 4,50 kanns nicht mehr weit nach unten gehen, außerdem haben diese Superanalysten ein Kursziel von US Dollar 4 angegeben, also auch bei Nichtzulassung denn DNDN hat ja noch mehrere Projekte in der Pipline "

@Magnetfeldfredy

Ich will Dir die hoffnung nicht nehmen sondern eher nur warnen ,denn wenn Provenge enttäuscht kannst du dein geld vergessen das wäre auch ein totalverlust für Dendreon .
In meinen augen ist Dendreon nicht mehr als ein zockerwert das aktuell auch noch hoch bewertet ist .

Scheitert Provenge droht das gleiche schicksal wie bei Genitope die mit ihren MyVax(vaccine) grosse hoffnungen hatten .

[edelupolino]

Antwort auf Beitrag Nr.: 33.649.552 von StaatsKnecht am 15.03.08 11:27:18

Trotz dauer-optimismus sind warnungen immer mal gut!

Ich geb auch nicht viel auf die pipeline (hört man zu wenig von und da wird auch nur geld verbraucht und nicht gemacht!!)

@ GuHu: ich versteh eigentlich nix von dem, was ocyan sagt (kein statistiker oder so...), höre nur heraus, dass das zu großen differenzen bei der auslegung der ergebnisse kommen kann/wird.

Gut scheint zu sein (für alle zukünftigen patienten), dass Prov wohl bei früh erkanntem krankheitsbild hilft, oder sehe ich das falsch?

[edelupolino]

Antwort auf Beitrag Nr.: 33.645.532 von edelupolino am 14.03.08 18:26:40

hier hab ich 1 hinweis auf ubs' kauf:

Posted by: Gregg | Mar 15, 2008 at 10:29 AM

I would like to know why UBS has a sell reccomendation for years with a target of about one dollar, and at the same time it's UBS ab has disclosed they own 5,200,219 shares as of 2/14/2008. How come we don't see a filing with the SEC for a 5% ownership? Seems UBS has an agenda, and does not care to speak the truth.

von:
http://blogs.forbes.com/sciencebizblog/2008/03/what-did-dend…

[GuHu1]

Antwort auf Beitrag Nr.: 33.649.552 von StaatsKnecht am 15.03.08 11:27:18

@staatsknecht
danke für deine warnenden worte, du hast recht, dndn ist ein risiko investment.
aber ist das nicht bei den meisten mittleren bis kleinen biotechschmieden der fall?

@magnetfeldfreddy
die 50:50 chance auf ausreichende interimsdaten besteht weiterhin(meine meinung).
mit den weiteren projekte kann man derzeit nicht rechnen, das sind keine großen kursstützen.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 33.649.552 von StaatsKnecht am 15.03.08 11:27:18

Wir werden sehen was kommt, ich bleib dabei!

[jethor tull]

Antwort auf Beitrag Nr.: 33.656.730 von Magnetfeldfredy am 17.03.08 09:02:01

Dendreon sell

17.03.2008 10:12:02

Zürich (aktiencheck.de AG) - Graig Suvannavejh und Steve Yoo, Analysten der UBS, stufen die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) unverändert mit "sell" ein.

Bei dem Conference Call zum vierten Quartal habe der Schwerpunkt auf der "Provenge"-Analyse gelegen. Damit bestehe nun zwar mehr Klarheit, eine ausreichende Transparenz sei jedoch nicht gegeben. So halte man bei der UBS die Daten vor der dritten Studienphase für keine solide Basis zur Einschätzung der Überlebensrate. Entsprechend sei man in Bezug auf die kurzfristigen Aussichten für "Provenge" weiterhin negativ eingestellt.

Das Unternehmen habe das Jahr 2007 mit einem Cashbestand von 120 Mio. USD abgeschlossen, allerdings sei davon auszugehen, dass die Cash Burn-Rate im laufenden Jahr relativ hoch sein werde. Bei der UBS habe man die EPS-Schätzung für das Jahr 2008 von -0,71 USD auf -0,93 USD gesenkt. Für 2009 sei die EPS-Prognose von -0,65 USD auf -0,76 USD reduziert worden. Das Kursziel für die Aktie werde von 4,50 USD auf 4,00 USD herabgesetzt.

Daher vergeben die Analysten der UBS weiterhin das Rating "sell" für den Anteilschein von Dendreon. (Analyse vom 14.03.08) (14.03.2008/ac/a/a)
Analyse-Datum: 14.03.2008



jethor

[SFJL]

FDA Agrees to Amend Dendreon's Special Protocol Assessment for Phase 3 IMPACT Study of PROVENGE
Monday, March 17, 2008 12:00 IST
Seattle, Washington

Dendreon Corporation said the US Food and Drug Administration (FDA) has agreed to an amended Special Protocol Assessment (SPA) for the phase III IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of Provenge (sipuleucel-T), the company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer.

In addition, the FDA has reconfirmed that they would accept a positive interim or final analysis from the IMPACT trial to amend the Biologics License Application (BLA) for licensure of Provenge.

The amended SPA accelerates the expected timing of the final IMPACT results by approximately one year while maintaining comparable powering of the study's interim and final results. By increasing the number of events and decreasing the alpha (false positive error) spending function for the interim analysis, the company is able to reduce the number of events for the final analysis (from 360 to 304) and still maintain a comparable statistical power for both the interim and final analyses. Interim results are still expected in the second half of 2008; however, final results are now expected in the second half of 2009 rather than 2010.

Based on the statistical plan in the amended SPA, if the treatment effect at the interim analysis for the IMPACT trial is consistent with the integrated results of the previous two completed phase III studies (D9901 and D9902A), Dendreon would expect to achieve the pre-specified criterion for significance and would amend the BLA submission with the FDA based on these interim results.

"The amendment of the SPA allows us to accelerate the expected timing of our final results by a year while maintaining comparable power for the study," said Mitchell H. Gold, president and chief executive officer, Dendreon. "Our commitment to helping patients with prostate cancer is unwavering, and we remain focused on providing the necessary data to the FDA as quickly as possible to enable us to bring PROVENGE to the men in need of a new treatment option."

The IMPACT trial is a randomised, double blind, placebo controlled Phase 3 study, which enrolled just over 500 men with metastatic, androgen independent prostate cancer with a primary endpoint of overall survival.

Provenge may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. In clinical studies, patients typically received three doses of Provenge over a one-month period as a complete course of therapy.

[hakur]

nach diesem besch..denen Tag wage ich mich jetzt doch mal aus der Deckung.
Der fallende Keil auf Tagesbasis wurde heute klar verletzt, muß jedoch noch die Bestätigung abgewartet werden.
Auf Wochenbasis gibts einen kleinen Hoffnungsschimmer, dort ist alles gerade noch im grünen Bereich. D.H. es war fast eine Punktlandung für heute im Tiefststand. Hat sich davon wieder etwas nach Norden zurückgezogen. Der Kurs ist wiet aus den Bollingern herausgelaufen, ist als positiv zu werden. Sollte ein pullback kommen. Die Bollinger sind nicht abgebildet , sorry , glaubts einfach.
Fast vergessen, auf Wochenbasis ist der fallende Keil noch intakt!
Ich für meinen Teil verkaufe kein Stück , habe vor 2 Tagen noch 10% nachgelegt. IST KEINE EMPHELUNG!!

So loong
Ps. Vieleicht gibts ja noch einen Techniker der hier mitliest, mehrere Meinungen sind immer produktiv!!
PPs. Denkt dran vor ziemlich genau einem Jahr waren wir bei 3,65$

[hakur]

Antwort auf Beitrag Nr.: 33.666.887 von hakur am 17.03.08 22:47:21

Olala , wurde glatt verschluckt
"IST KEINE EMPFEHELUNG"
der Inhalt wird hiermit aufrechterhalten

Hab es vergessen, heute wurde ein Gap von 4,61 bis 4,52
bei der Eröffnung gerissen. Gaps wollen bekanntlich geschlossen werden.
so loong

[edelupolino]

Antwort auf Beitrag Nr.: 33.666.887 von hakur am 17.03.08 22:47:21

lege aber nicht zu viel nach:

die IV mitglieder, die sich über positive oder negative interptetationen der zahlen austauschen, sind auch ziemlich verunsichert.

Halte lieber noch was für relativ sichere aktien wie BMW o.ä. übrig...

[hakur]

Antwort auf Beitrag Nr.: 33.670.043 von edelupolino am 18.03.08 11:41:06

Hi Ede im Prinzip gebe ich Dir recht!

Bin jetzt ca 2,5 Jahre hier dabei , habe währenddessen festgestellt dass die Stimmung immer mit dem Chart korreliert.
Selbst bin ich da auch nicht ganz unabhängig davon, zieht mich sicher auch immer wieder in die eine wie andere Stimmungslage.
Im Moment sind die Meinungen zweigeteilt, die Shorts freut es.

-Denke jeder hier sollte für sich selbst klar gemacht haben ob und wenn ja warum er an die Firma glaubt. Andernfalls wird man Spielball des Marktes und seinen Kräften.-

Ich für meinen Teil versuche halt viel über den Chart zu klären, kurz wie langfristig. Charts erzählen Geschichten wie jede graphische Äußerungen.
Wesentlich dabei um jetzt auf die Stimmung und Korrelation zum Chart zurückzukommen, muß ich immer wieder lernen, dass ich mich nicht von kurzfristigen Trends beeinflussen lasse sondern immer auch die mittelfristige--und langfristige Situation im Fokus behalte. Muß immer wieder neu abgeklärt werden und hinterfragen.- Die Storry der Firma sollte mich natürlich interessieren und ich auch daran glauben können.
Der Ansatz mit dem Chart und seiner graphischen Geschichte ist sicher etwas quer zur Chart-Technik aus den Büchern, nur schwer rational zu vermitteln, bewusst oder unbewusst nehmen wir ständig im Alltag solche Bilder wahr und reagieren darauf ohne es uns jedes mal bewusst zu machen. Außerdem gibt es da ja auch noch die schulmässige Chart Technik, ohne diese geht es auch nicht.

so loong

PS. bin mir bewusst dass es immer ein Risiko gibt, war ich mir auch vor dem 9.Mai letzten Jahres.

[edelupolino]

Antwort auf Beitrag Nr.: 33.670.915 von hakur am 18.03.08 12:52:22

Hi hakur,
so ein chart spricht natürlich bände; und am liebsten sind mir die trends, wo die aktie sehr lange über der 200-er läuft -oder sie nur mal in einer extremen panikzeit wie jetzt so eben streift oder mal ein paar situngen unter sie abtaucht, (Beispiel Aixtron, oder vor einiger zeit Puma, oder Ping An von 05-07).
Solche trends sind zum richtig geldverdienen.

Bei dndn kann ich nur den fachleuten glauben, ob Provenge wirkt. Wenn der krebs gehemmt wird, wenn endlich FDA-offiziell gesagt wird, dass Provenge den kranken hilft, dann ist die jetzige dreiecksformation wie eine raketenrampe für den kurs!!

[GuHu1]

ich für meinen teil denke dndn weiß genau warum sie spa und bla in übereinstimmung mit der fda verändert haben.
die genauen daten der studien 9901,9902a und das design von 9902b kennt nur dndn, kein aschoff oder cramer auch nicht ubs usw..

Dendreon Corporation said the US Food and Drug Administration (FDA) has agreed to an amended Special Protocol Assessment (SPA) for the phase III IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of Provenge (sipuleucel-T), the company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer.

In addition, the FDA has reconfirmed that they would accept a positive interim or final analysis from the IMPACT trial to amend the Biologics License Application (BLA) for licensure of Provenge.

PS: schließe mich hakur an, keine kaufempfehlung!

[edelupolino]

Antwort auf Beitrag Nr.: 33.679.697 von GuHu1 am 19.03.08 00:03:34

die genauen daten der studien 9901,9902a und das design von 9902b kennt nur dndn, kein aschoff oder cramer auch nicht ubs usw..

das kann trösten, aber ich trau A. und Scher etc zu, dass sie ihre dollars auch zur bestechung einsetzen werden (zumindest versuchen...);
man wird immer misstrauischer...

[GuHu1]

in diesen tagen freut man sich schon wenn dndn wenigstens mit
hold rating und einem kursziel von $5,00 bewertet wird.

wenn ich mich recht erinnere war zacks.com immer eher pro dndn.

hat jemand die komplette analyse parat?

http://www.earthtimes.org/articles/show/zacks-analyst-blog-h…

[GuHu1]

Antwort auf Beitrag Nr.: 33.685.322 von edelupolino am 19.03.08 14:33:36

hi ede,
was mich stört, ist die theoretische möglichkeit, dass diese ratten einblick auf die genauen anforderungen für die interimsdaten bekommen (natüüüürlich zufällig).

die darf nur die fda und dndn kennen. die veröffentlichung oder aber weitergabe dieser informationen obliegt einzig dndn!

andererseits sollte man hier gaaanz vorsichtig sein, könnte mir vorstellen das man mehr als ein auge darauf hat.

[edelupolino]

Antwort auf Beitrag Nr.: 33.692.182 von GuHu1 am 19.03.08 23:19:05

Hi GuHu,
ich glaube auch, dass die gemeinten typen vorsichtiger agieren, weil US-Senatoren im bilde sind; aber andererseits sind die und waren die so dreist, dass ich mir bei denen fast alles vorstellen kann.

Das einzig wahre wäre, wenn Gold mal so 200.000-500.000 dndn aktien über den markt kauft!!

Das wär ne echte tat -und 1 schock für die shorts...

[GuHu1]

http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2008/…

[GuHu1]

meinung aus zum link dem IV

The truth may finally come to light on the rogue traders who pose as journalists and independent researchers of Dendreon.

The time is now to send your comment to the SEC regarding the naked short selling rules that are now open for public comment. Describe the countless times that so called independent analysts have openly lied about DNDN's clinical trial data, putting fire on the rumour mill, only to be followed by so called journalists commenting on these rumours and outright lies, and how short selling ensued. Mention the huge short interest on DNDN, mention the Reg Sho list etc. Mention the involvement of a lead investigator/investor in a competing drug, who became the lead FDA Advisory Committee member to torpedo the approval of Dendreon's drug, who likely also had significant ties to many investment funds who were happy to see Dendreon fail.

The time is now to take action, the SEC and Congress are looking for a case which is prosecutable, a case which can lay bare the clear manipulation of hedge funds that has nearly brought down the financial system. Dendreon is that case. Raise your voice again!

[GuHu1]

Antwort auf Beitrag Nr.: 33.707.863 von GuHu1 am 22.03.08 14:52:54

meinung aus zum link dem IV =

meinung zum link aus dem IV

[edelupolino]

Antwort auf Beitrag Nr.: 33.707.865 von GuHu1 am 22.03.08 14:54:31

die haben natürlich recht, da jetzt zu handeln und diese üblen praktiken zu enthüllen; ich wünsche ihnen alles glück dieser erde, denn das ist nötig, weil die kriminellen shorts und fonds -die ähnlich wie die echte MAFIA handeln- sich bestimmt durch tricksereien, bestechung etc wehren...

Wenn überhaupt eine zeit für erfolgreichen kampf gegen diese kriminellen typen gegeben ist -dann jetzt!! (der reporter des Telegraph spricht überzeugend!! "The hedge fund, which cannot be named for legal reasons, stood to make millions from "short-selling" the shares as they fell in value.

The allegations — made in a sworn statement seen by The Daily Telegraph and which has been sent to financial regulators — will add to growing concern over the activities of rogue traders in the City...)
Die Sauerei ist natürlich dass die namen nicht genannt werden dürfen: die gangster genießen den schutz der gesetze!!! das ist die bekannte schwäche unserer gesetze...

[GuHu1]

hi ede,
haste leider recht, ich denke das diese enthüllungen dndn ein wenig mehr in die karten, da wird weitaus genauer geschaut!
schon alleine durch die gute arbeit im IV.

kaum gesagt und:

http://www.nj.com/timesoftrenton/stories/index.ssf?/base/bus…

auf seite 2 wird über prostata vaccine siniert.

hierzu wieder einer der ANAlysten!

Even if Gvax and Provenge reach the market, industry analysts do not expect huge sales. Marcus Hoyle, an oncology analyst with Decision Resources, expects sales of Provenge could reach $200 million.

ich habe hier eine ganz andere prognosen vom kollegen feuerstein im hinterkopf.
nun ja, wie es gerade passt werden daten aussichten und erwartungen von diesen leuten gestreut.

[GuHu1]

http://www.nytimes.com/2008/03/23/business/23every.html?_r=1…

.........The new part is the hedge funds and the changing of Wall Street from a financing entity to a market manipulation entity. The new part is hedge funds with (supposedly) $1.5 trillion in capital, immense hedge funds within banks and investment banks. The new part is that they have so much money and so much selling power that they can do what capitalists really want and love to do: to make money not by betting on the markets, but by controlling the markets, by putting so much sell side (and occasionally buy side) firepower in play that they know they will move the markets. This takes all that annoying uncertainty out of it..........

[edelupolino]

Antwort auf Beitrag Nr.: 33.710.387 von GuHu1 am 23.03.08 19:27:58

Hi GuHu,
wenn dndn und andere in den klauen von spielern mit solch einer marktmacht sind, hilft nur noch eins:

der staat (so sehr ich gegen ihn bin!!!) muss handeln wie damals gegen Rockefeller und seine ÖLMACHT, als sein imperium ich glaub in 7 unternehmen aufgeteilt wurde...
Gute nacht
Ede

[edelupolino]

Antwort auf Beitrag Nr.: 33.710.658 von edelupolino am 23.03.08 21:21:37

...hab gerade mal nachgeschaut:laut Wikip. waren es über 30.
Ein derart rigoroses eingreifen auf dem "short-sektor" wäre hilfreich!

[Uptick08]

Antwort auf Beitrag Nr.: 33.670.043 von edelupolino am 18.03.08 11:41:06

Halten, halten, halten...

Tja, DNDN habe ich dementsprechend auf ein "strong halten" Status eingestüft zurzeit (aber ein Verkauf kommt mir auch nicht im Sinn)



Too many good possibilities in the chart whilst trading off the yearly ATH...

[edelupolino]

Antwort auf Beitrag Nr.: 33.711.398 von Uptick08 am 24.03.08 10:45:22

steigt ja heute wieder in USA...

[GuHu1]

ocyan + clarksterh, IV:

<... Given the above reason, I say let's not be too sure about the 1.45 to 1.4 walk-down yet. It could be from 1.5 to 1.45, or 1.7 to 1.65.>

Good reasoning. That's about what I have been saying. The recently announced power of the IMPACT study is likely modeled using new information beyond the published survival curves. Given what DNDN know now of the enrolled patients, it is likely that they see the original power calculation when IMPACT was designed in 2005 as conservative.

For example, by extrapolating the survival probability of the 36-months survivors using an exponential model, the HR for D9902a improved to 1.45 with confidence interval [1.21,1.60]. This gives a small signal that the relatively sicker D9902a population might have exaggerated the delay effect, hence, masking the drug effect and resulting in a smaller trial HR when cut off at 36 months.

So, if DNDN now believe that the IMPACT patients are relatively healthier than D9902a and more similar to D9901, then with the additional knowledge of patients who have been around much longer than 3 years, they could have more confidence in using a higher starting HR in their model. In that case, even with a step down due to the reduced trigger size, the estimated probability of success, ie, power, of the trial might not decline much.

wen die diskussion über die auswirkungen zur letzten news interessiert:

http://www.investorvillage.com/smbd.asp?mb=971&mn=189297&pt=…

[GuHu1]

http://www.washingtonceo.com/home/story-display/article/312/biotech-dru.html

[bua321]

Heut siehts ja wieder gut aus !

die Pferde saufen wieder + die Karavane kann nun weiter uffi ziehen !

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 33.730.251 von bua321 am 26.03.08 15:25:45

Ich glaube da steckt mehr dahinter, kommen vielleicht schon die Daten zu der laufenden Phase 3 Studie?

[bua321]

Antwort auf Beitrag Nr.: 33.730.672 von Magnetfeldfredy am 26.03.08 15:54:50

hmmm wer weis !?

[NoSelters]

http://www.schaeffersresearch.com/commentary/content/can+den…

Bleibt spannend.

No

[Larry_1]

Bin seit heute auch wieder dabei.
Kann einfach nicht sein, das der Kurs ohne mich anzieht.

[Larry_1]

Kursanstieg bei schlechtem Allgemeinmarkt, riecht förmlich nach Rendite!!

[GuHu1]

schön das es mal wieder up geht, noch ist dndn schließlich im rennen.
aber vorsicht, es steht bisher keine news dahinter (soweit ich weiß) und bis zum interim look dauerts noch.

thx no

[NoSelters]

Antwort auf Beitrag Nr.: 33.734.330 von GuHu1 am 26.03.08 20:58:29

Eine Chartanalyse von Hakur wäre jetzt sicher interessant.

Vielleicht erbarmt er sich?


Grüsse,

No

[GuHu1]

Antwort auf Beitrag Nr.: 33.734.415 von NoSelters am 26.03.08 21:07:11

hakur ist im urlaub, weiß nicht ob er zeit hat.

[edelupolino]

Antwort auf Beitrag Nr.: 33.732.947 von NoSelters am 26.03.08 18:51:51

ein artikel nach meinem geschmack!!

TOTALER pessimismus wie bei dndn im moment (autor gibt viele beispiele!!!!) war schon immer ein indikator für die gegenrichtung...
...dazu ist der chart ihrer meinung nach äußerst aufschlussreich und deutet den ausbruch NACH OBEN an...
Hoffentlich!!

[edelupolino]

Antwort auf Beitrag Nr.: 33.734.415 von NoSelters am 26.03.08 21:07:11

findest du in dem artikel.

[edelupolino]

aus IV von heute:

Close
We all knew it would not close above $5. Have you ever owned a more frustrating stock? What's with the .70 climb this am and then the .19 finish. Very typical DNDN. It is about time management bought some shares!

genau mein reden: dann würd die post abgehen! Go Gold,go and buy, you lily-livered fraidy-cat!!!!!!!!!!!!!!!!!!!!!!

[GuHu1]

Antwort auf Beitrag Nr.: 33.734.279 von Larry_1 am 26.03.08 20:52:05

Latest Short Interest up over 1.5 million to 36.5,,, same old same old...

Hi Larry, mal schaun wie es für dich bei dndn läuft.
ich wünsch dir ein gutes händchen.

[GuHu1]

http://www.marketintelligencecenter.com/articles/568268

[Larry_1]

Antwort auf Beitrag Nr.: 33.734.955 von GuHu1 am 26.03.08 22:17:58

Danke.
Seit der Encysive "Explosion" sind schon wieder einige Wochen vergangen, habe das Ereigniss aber gerne in Errinnerung
DNDN ist für mich eigentlich auch ein klassischer Übernahmekanditat..

[StaatsKnecht]

DNDN ist für mich eigentlich auch ein klassischer Übernahmekanditat..

Wovon träumst Du nachts ?
Wenn sich jemand für Dendreon interessieren würde dann hätten diejenigen längst gehandelt .
Provenge kostet 430 million US$ nicht gerade wenig für ein produkt das bisher nicht überzeugt hat !!!
Ich prophezeie das selbe Schicksal wie bei GPC nur mit dem unterschied
das Dendreon ein pennystock wird.

Short interest ist wieder am steigen auch nicht gerade ein gutes zeichen !
http://www.nasdaq.com/aspxcontent/shortinterests.aspx?mode=&…

Trotzdem viel Glück

[GuHu1]

Antwort auf Beitrag Nr.: 33.745.263 von StaatsKnecht am 27.03.08 21:56:13

Provenge kostet 430 million US$ nicht gerade wenig für ein produkt das bisher nicht überzeugt hat !!!

sollte es zur zulassung in Q4 2008 reichen , was denkst du ist provenge bzw. die patentierte casettentechnologie dann wert?

Ich prophezeie das selbe Schicksal wie bei GPC nur mit dem unterschied das Dendreon ein pennystock wird.

der vergleich hinkt, soweit ich weiß hat gpc nicht einmal ein AC überlebt!

Short interest ist wieder am steigen auch nicht gerade ein gutes zeichen !

richtest du eine anlage im biotechsektor an der shortquote aus?
denk an den märz 2007.

es ist und bleibt ein risikoinvestment mit einer 50:50 chance.

[StaatsKnecht]

Antwort auf Beitrag Nr.: 33.745.996 von GuHu1 am 28.03.08 00:52:51

richtest du eine anlage im biotechsektor an der shortquote aus?

Nein nicht unbedingt aber bei über 36 million aktien short würde mir das schon zu denken geben ,ausserdem investiere ich niemals in ein Unternehmen das nur von einem Produkt abhängt .

Sorry aber ich drücke Dir die daumen.

[GuHu1]

hi staatsknecht, keine sorrys es ist dein gutes recht den wert kritisch zu bewerten.

ich wollte nur kurz unterstreichen weshalb es interessant ist eine kleine risiko position in dndn zu investieren. bei den 36 mille short sind natürlich die nacked shorts nicht berücksichtigt.

ich denke wir sind uns einig, dass das risiko hoch ist.
tenbagger oder niete mit einer chance von 50:50.

[GuHu1]

http://www.beaconequity.com/index.php?option=com_content&tas…

[Larry_1]

Antwort auf Beitrag Nr.: 33.745.263 von StaatsKnecht am 27.03.08 21:56:13

StaatsKnecht
ich hab schon Pferde kotzen gesehen....
Diese Aussage kann ich überhaupt nicht akzeptieren:
Wenn sich jemand für Dendreon interessieren würde dann hätten diejenigen längst gehandelt .

GuHu1
guter link, hier kann man sich einen schnellen Überblick verschaffen ----> DNDN "hängt" also nicht nur an Provenge

[StaatsKnecht]

Antwort auf Beitrag Nr.: 33.752.114 von Larry_1 am 28.03.08 16:26:57

DNDN "hängt" also nicht nur an Provenge

An was denn noch ? Fällt Provenge durch ist die story von Dendreon beendet .
Nicht das ihr mich falsch versteht wenn es nach mir ginge sollte Dendreon sofort auf 20 € springen aber tatsache ist das hier das risiko überwiegt .

http://www.dendreon.com/dndn/pipeline

[GuHu1]

hi staatsknecht,
wer hätte nicht gern einen möglichen tenbagger für lau im depot?

http://www.nasdaq.com/services/riskMetrics.stm?&tickers=DNDN…

[edelupolino]

Antwort auf Beitrag Nr.: 33.756.291 von GuHu1 am 29.03.08 00:06:57

klasse link,GuHu,
ich sehe, ich liebe das risiko...
...und nur mit hohem risiko kann man bekanntlich hoch gewinnen.

[GuHu1]

http://www.pharmalot.com/2008/03/the-provenge-anniversary-ro…

[NoSelters]

Das hatte halt Stiel....vielleicht regt es die Richtigen zum Nachdenken/forschen an.

http://www.pharmalot.com/2008/03/the-provenge-anniversary-ro…

So loooong...

No

[NoSelters]

@ guhu:

Uuuups...hatte deinen Link nicht gesehen.

Doppelt hält besser.

No

[GuHu1]

Brian Lawler from Motley Fool
<<One other thought worth pondering: If Cell Genesys' GVAX prostate cancer immunotherapy could convince Takeda to fork over more than $300 million in up-front and potential milestone payments after the kind of clinical study results it has produced, don't you wonder how much Dendreon (Nasdaq: DNDN) could get if it partnered out its prostate cancer immunotherapy, Provenge?>>>

He has been trashing DNDN for quite a while.

This is the most positive statement that I can recall him making.

http://www.investorvillage.com/smbd.asp?mb=971&mn=190728&pt=…

[GuHu1]

Antwort auf Beitrag Nr.: 33.783.221 von GuHu1 am 01.04.08 21:51:35

anbei der link zum motley fool artikel.

http://www.fool.com/investing/high-growth/2008/04/01/a-littl…

[GuHu1]

http://seekingalpha.com/article/70632-dendreon-corporation-q…

gedanken dazu aus dem IV:

Re: From Seeking Alpha......
Hi all,

I've been reading this board for years now but have refrained from posting because (1) while I did a math major in undergrad, I've had very little I could possibly add to the educated discussions here, and (2) I work in the M&A industry at a very high profile firm and usually refrain from posting on public boards. I have been, like most here, been just as outraged by how the Provenge story has developed over the last year and have been at the same time just as amazed by the efforts in supporting the cause that have been put together by this MB. I wish I could support such efforts as well but it would be a tricky proposition considering my line of work even if the firm I work with has no involvement whatsoever with DNDN. So this post was meant mostly to point out that there's more support to the Provenge cause out there than some imagine - but I'm sure most of you already knew this.

In any event, in an effort to contribute something other than a vapid pat on the MB's back, I wanted to share a couple of observations from the Q-end CC transcript, which I finally found time to read.

1. While Ocyan, clark and the rest of the science/stat gurus have probably already discussed these points much more elaborately then I ever can (apologies if I missed it, I don't get to read the MB as often as I'd like), Mitch did seem to provide a pretty clear explanation of the admittedly cryptic "alpha spent/comparable power/reduced events" language from the PR that caused much headstratching. I think it's pretty clear that they (i) increased the number of events for the interim; this increase would, if nothing else changed, increase the power of the interim; (ii) because of this increase in interim power, they were able to reduce the alpha spent (i.e., decrease p value) of the interim; (iii) the reduced alpha spent on the interim increased the alpha available to the final (since the total they have, .05, is constant); (iv) the increased alpha for the final allowed them to reduce the number events in the final while keeping "comparable power" to what they had before the change. These offsets or transfers of function are not exactly identical so (i) was not completely offset by (ii) and (iii), resulting in somewhat increased power of the interim (though I bet the increase is not that big). On same note, the power of final went down a bit - they could have presumably kept it at 90% exactly had they chosen to set it at more than 304. (I can't help but re-laugh here at Dew's techinically correct yet quite irrelevant remark made a few weeks ago that they had just increased the chance of failure of the final by 20%).

2. I thought one other thing was interesting - Mitch made this point a couple of times and seemed quite keen on it. When they guided to 2nd half of this year for the interim, they made the guidance on the assumption that the FDA had approved the amendment to the protocol. But the amendment increased the event number for the interim (if I'm correct above). It is possible then, had the amendment not be granted, the interim would have already taken place (i.e., as per the original protocol) because fewer events would have triggered it. In other words, they took on some risk with their guidance because they would have been faced with some tough questions had the interim occurred in (say) April when they guided 2nd half especially if the interim had missed (we'd have gotten just a PR to that effect but the "early" arrival would have lead to some ultimately wrong conclusions that IMPACT is not doing great since the interim came "early"). Maybe I'm reading too much into this but more knowledgeable people than me here have suggested that such amendments are very rare, yet DNDN pretty much assumed it away - I'm not entirely sure how much to read into such confidence. It does suggest, though, that they've been thinking about this for a long time and that incoming data (i.e., the raw deaths they see) is following a certain pattern that they are watching very carefully (and seem happy with - Mitch went out of this way to point out conformity with the integrated 9901 on this issue)

Responses, of course, are welcome but I'm off to my daily dose of unpredictable meetings and calls.

[hakur]

Antwort auf Beitrag Nr.: 33.666.887 von hakur am 17.03.08 22:47:21

Die obere Begrenzung des fallenden Keiles verläuft bei ca 5,03 $, wäre schön wenn die endlich mit dem heutigen Close geknackt wird.
Bedarf in den nächsten Tagen jedoch nachhaltiger Bestätigung!!


so loong

[NoSelters]

Fakt ist,...es gibt keine neuen Fakten derzeit!

Aaaber so wie es im Moment wieder brodelt überm Teich,und wenn nötig weiter brodeln wird,...immer wieder...ohne Ende...,hab ich persönlich mittlerweile wieder ein "saugutes" Gefühl.

Schaut euch nochmals die Videos der letzten Rally auf youtube an!(Starke Gefühle)

Das alles wird weitere Kreise ziehen und Spuren hinterlassen. Geduld ist angesagt.

Go Dendreon,Go!

No

[surga]

http://www.investorvillage.com/smbd.asp?mb=3440&mn=15696&pt=…

Re: Anyone here own DNDN?

I own some too. I sold most of my Elan a year last Jan to go into Dendreon, sold most after Black Wednesday (still made about 10%) and went back into Elan. Then last Nov I sold some ELN and bought NBIX -- sold more after Indoplon's fiasco to get more NBIX. Short term plan is to sell half of NBIX after the partnership and go back to Elan for the Alz news in June/July. After that, I'll sell some Elan to go back more fully into Dendreon.

*grin* If only it were that easy!!!!

But I really like Dendreon too. They were screwed over by the FDA -- their Advisory Committee voted 17-0 for safety and 13-4 for efficacy. Out of the 4 "no's", 2 have been shown to have had massive conflicts of interest -- Dr Scher was actually the undisclosed lead investigator to Novacea's Asentar, a competitor who co-incidentally signed a huge partenership 3 weeks after the FDA said no to Provenge. He also wrote a letter to the FDA (leaked) after the AC meeting about the sleepless night he'd had imagining the horrors if Provenge were to be approved.
Provenge looks to have interim results available sometime in the second half of '08 -- they modified their SPA with the FDA to allow a later interim, and an earlier final (supposedly second half of 2009, now, instead of 2010), and did not lose much if any power or alpha on either look.

They have enough cash and financing structures in place to allow at least through the interim without dillution. The stock is around $5 now -- it was between $15 and $25 last year between the AC vote and the FDA's CRL. Also has an enormous short position -- been played with as much or more than Elan and Neurocrine has been.

Regards,
Trond

[HeinzBork]

Dendreon Announces $47 Million Registered Direct Offering

http://www.streetinsider.com/Press+Releases/Dendreon+Announc…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 33.798.833 von HeinzBork am 03.04.08 14:09:22

Der Investor der gekauft hat, weiß schon warum!

[Uptick08]

Antwort auf Beitrag Nr.: 33.798.833 von HeinzBork am 03.04.08 14:09:22

Das hört sich echt gut an...wo hat der Investor sein "strammen Zeitplan" nur her????

The investor has agreed to purchase the shares of common stock and warrants to purchase common stock at a negotiated purchase price of $5.92 per share and a warrant exercise price of $20.00 per share. For the common stock purchased, this represents a 17% premium to the closing bid price of the common stock on April 2, 2008

A made to measure "Finanzierung"?...17:0

Mal sehen sagt der blinde

[hakur]

Antwort auf Beitrag Nr.: 33.799.191 von Uptick08 am 03.04.08 14:41:02

Würde zum fast einjährigen fallenden Keil passen!
Chart ist zu sehen im Beitrag vom 10.03.2008
Mal sehen ob der Chart jetzt seine Bestätigung erhält, sieht auf jedenfall gut aus.

so loong

[Uptick08]

Antwort auf Beitrag Nr.: 33.799.403 von hakur am 03.04.08 15:00:37

yeo...könnte so ein Stein des Anstoßes sein

[GuHu1]

Mike Huckmann`s kommentar:

http://www.cnbc.com/id/23941575/site/14081545?__source=yahoo…

[GuHu1]

Antwort auf Beitrag Nr.: 33.799.403 von hakur am 03.04.08 15:00:37

hi hahur mal schaun ob dndn sich über den 5,03 hält.
übrigens, supermanns freundin bleibt bei den nächsten wochen.

[GuHu1]

http://www.247wallst.com/2008/04/motivation-behi.html

[NoSelters]

http://blog.seattlepi.nwsource.com/thelifesciencesblog/archi…

No

[GuHu1]

DNDN`s CFO Greg Schiffmann zum deal:

http://blog.seattlepi.nwsource.com/thelifesciencesblog/archi…

[GuHu1]

Antwort auf Beitrag Nr.: 33.805.035 von NoSelters am 03.04.08 22:57:09

diesmal sorry von mir no, hab deinen link auch zu spät gesehen.

[NoSelters]

Antwort auf Beitrag Nr.: 33.805.052 von GuHu1 am 03.04.08 22:59:35

war ja nur ne Minute Unterschied.

[GuHu1]

stand 11.03
Environmental Health & Safety Specialist
Human Resources Coordinator (long term temp)
Regulatory Technical Writer (long term contract)
Sr. Accounts Payable Specialist (temp)
Sr. QA Associate Quality Systems
Sr. Quality Computer Validation Specialist

stand 03.04
Environmental Health & Safety Specialist
QC Assoc II - Biochemistry Seattle WA
Sr. QA Associate Quality Systems
Sr. Quality Computer Validation Specialist

dndn stellt ein und schreibt neue stellen aus, alles ohne zugelassenem produkt.

[hakur]

Antwort auf Beitrag Nr.: 33.804.931 von GuHu1 am 03.04.08 22:41:23

Hi guhu,
kannst Du genaueres über Supermanns "Prediction" mitteilen?
Habs wohl übersehen.
Thanks
so loong

[edelupolino]

Antwort auf Beitrag Nr.: 33.805.308 von GuHu1 am 03.04.08 23:41:16

...ist fast so überzeugend und verführerisch wie wenn Gold ein paar (so 50.000) aktien kaufen würde...

[GuHu1]

http://advancedprostatecancer.net/?p=291

[surga]

zur Veranschaulichung

[GuHu1]

............With this financing Dendreon Corp, is moving one step closer in their business model. Dendreon will use the proceeds of this financing agreement to continue commercializing their Prostate theraputic drug PROVENGE; funding of additional clinical trials for other immunosuppresent therapies and invest in specialized technology systems. The combination of this financing agreement and the successful results of Dendreon's Clinical Trials with PROVENGE, Ludlow Bioventures has initiated coverage on DNDN, and is adding DNDN to our client watch list.

With around 40% of the company's public float held short, and the success of their clinical trials with PROVENGE, Ludlow BioVentures believes Dendreon Corporation has greater up-side potential from these levels.

http://www.ludlowcapital.com/reports/bio/dndn.html

[Larry_1]

DNDN legt einen Super Wochenausklang hin, einfach Klasse.

guHu1"dndn stellt ein und schreibt neue stellen aus, alles ohne zugelassenem produkt"
da machen sich wohl ziemlich viel Anleger (positive) Gedanken

Schönes WE

[GuHu1]

Antwort auf Beitrag Nr.: 33.813.440 von Larry_1 am 04.04.08 19:39:15

....da machen sich wohl ziemlich viel Anleger (positive) Gedanken

nun keine ahnung was die anleger so denken. ich wollte es nur nicht unerwähnt lassen.

ps: mal was anderes, haste nen glückstaler in der tasche oder wie. das ist nun schon der zweite kauf zum richtigen zeitpunkt.

[Larry_1]

Antwort auf Beitrag Nr.: 33.813.535 von GuHu1 am 04.04.08 19:48:11

ganz einfach:
Börse besteht zum überwiegenden Teil aus Emotionen und Spekulation.
Dies mache ich mir in letzter Zeit einfach zu Nutzen (nach jahrelangem Üben und teils auch heftigen Verlusten)
Ab und zu gelingt mir dann eben auch der richtige Zeitpunkt zum Ein und Ausstieg aus einem Wert.

Aber die Amis spinnen doch heute wieder mal richtig, die ignorieren doch glatt die wiederum schlechten Arbeitsmarktdaten und Rezionsängste und das an einem Freitag.

NS: LDK Solar machte heute auch richtig so Spaß

[GuHu1]

http://www.fool.com/investing/high-growth/2008/04/04/a-few-t…

A Few Thoughts on Dendreon
By Brian Lawler April 4, 2008

I've received quite a number of emails on Dendreon (Nasdaq: DNDN) since my last two columns on the drugmaker. Following are a few noteworthy thoughts that readers and I have discussed via email and in The Motley Fool discussion forums.

A lot has been written about the upcoming interim look at the efficacy data from Dendreon's phase 3 IMPACT study for its prostate cancer treatment Provenge. Many analysts, like me, don't think the odds are very high that this look (which will occur later in 2008) will be a success. The reason is that the FDA sets a very high hurdle that drugs have to overcome in an interim data peek.

For example, in Dendreon's D9901 phase 3 trial, the p-value hurdle that it had to beat for that study's interim look at its primary endpoint was 0.001 -- that means the survival data from the two treatment groups needed to be different enough to show that there was only a 0.1% chance that the results from patients receiving the drug were identical to the results from those not receiving the drug. Because of this interim look, the FDA penalized Dendreon on its final data reveal and made the final data p-value that it had to beat 0.049 instead of the customary 0.050 without an interim look. Dendreon hasn't said what the interim or final p-value hurdle is for the IMPACT study, but if the interim p-value hurdle is anything like 0.001, then it will be tough for Dendreon to hit this mark on the study's overall survival endpoint.

The sample size in IMPACT is much larger than the past two phase 3 studies for Provenge (D9901 and D9902A) combined, so that's the good news for Dendreon investors betting on a positive interim look (a larger sample makes hitting a particular p-value easier since the randomness gets evened out). Even combining the excellent overall survival Provenge results from its previous two phase 3 studies though, the p-value for overall survival in those studies only reached the 0.011 significance level, so you can see how much of a hurdle getting to 0.001 may be.

The good news is that if Dendreon's Provenge does show an improvement in overall survival at the interim IMPACT data peek later this year, and the results are relatively clean, then the FDA will likely approve Provenge extremely fast.

Even a failed interim look could still be a very positive and exciting sign for Provenge. If Provenge fails at the interim, just knowing that the interim look failed is not the most important issue, what matters is how closely it failed at the interim. If the interim data is showing that the Provenge-treated patients are trending strongly toward an improvement in their overall survival versus the control group, then the odds of the final 2009 IMPACT analysis being a success will have gone up. This was one of the things that got me excited about GPC Biotech (Nasdaq: GPCB) last year after its lead drug was positively trending toward improving overall survival in prostate cancer. Unfortunately, the final results showed that trend to disappear.

Investors should also remember that there are real risks involved with the interim look besides just failing to beat the tough efficacy hurdle. If Provenge were to perform poorly enough at the interim look, and the data monitoring committee calculated that there was little chance of the drug outperforming the control group, then the study could be scrapped at this point.

Unfortunately for investors, I don't think we will get to know how closely Provenge will fare at the interim because that info will probably remain confidential, aside from the top-line "interim failed" or "interim succeeded" overall survival data announcement. There are good reasons for not revealing the hard numbers to accompany these top-line results, but hopefully Dendreon will give us some sort of data nuggets to chomp on even if the interim study results are not good (or bad) enough to end the trial early.

tja müssen erst die stat. guys aus dem IV die herren analysten zum nachdenken bewegen.
leide lawler, denn die hürde darf nur die fda und dndn kennen.

das bleibt weiterhin ein risiko investment.

[GuHu1]

stat. guy ocyan zum fool artikel (IV) :

<Dendreon hasn't said what the interim or final p-value hurdle is for the IMPACT study, but if the interim p-value hurdle is anything like 0.001, then it will be tough for Dendreon to hit this mark on the study's overall survival endpoint.

The sample size in IMPACT is much larger than the past two phase 3 studies for Provenge (D9901 and D9902A) combined, so that's the good news for Dendreon investors betting on a positive interim look (a larger sample makes hitting a particular p-value easier since the randomness gets evened out). Even combining the excellent overall survival Provenge results from its previous two phase 3 studies though, the p-value for overall survival in those studies only reached the 0.011 significance level, so you can see how much of a hurdle getting to 0.001 may be.>

Brian Lawler continues to show his laziness and ignorance as an analyst. If people here already know that IMPACT is using O'Brien-Fleming for alpha allocation, it shouldn't be hard for him to pick up the phone and call the company to confirm. As I already explained in other posts, using OBF means that the interim alpha is purely a function of the interim trigger number. Now, if Lawler is just do half the job of some people here to cursorily look at the enrollment rates, he would know that the trigger will have to be at least 220 if it is to happen in 2H08 as DNDN projected. As such, the lower bound for the interim alpha according to OBF will be 0.017, not the ridiculous .001 that he mentioned. Beware of the Fool(s)!

[GuHu1]

IV stat. guy ocyan:

Recs: 8 Re: From Motley Fool...../eagle
I won't comment on investment strategy as that must be your own decision. But, what your question gets to is to estimate the chance that the interim look will be successful. I can't tell you what that is either. But below are a few thoughts that you might find useful.

The power (chance of success) of the interim (or final) look roughly depends on two factors, the alpha and the hazard ratio. The interim trigger should be 220 or higher to be in 2H08. So the alpha will be 0.17 or higher. For the sake of argument, say, we assume 240 to be the trigger. Then the corresponding interim and final alphas would be .023 and .043.

Assuming the integrated data D9901+02a as the model, the HR would be around 1.36. Together, that would give you the interim power at 50% and the final power at about 75%. So the interim chance would be just about a coin flip (even so, that is astronomically larger than what Brian Lawler would have you believe.) On the other hand, note also that the final power above is only 75% which is much lower than the 88% that DNDN projected.

Now you have a choice to make. You can continue believing that D9901+02a is the correct model. That is, DNDN stat people don't know squat about what they are doing when they came up with that 88% for the final look. In that case, you stay with the above projections. Alternatively, you can think that DNDN is using some other model that incorporates better data than just D9901+02a. In that case, the 50% for the interim would be just a lower bound and the chance of success for the interim should be higher. Note also that the interim chance could also go up if you assume the trigger to be higher than 240, etc.

The bottom line is that to guess what the real chance for the interim is while not working for DNDN would require making assumptions beyond the data on hand. It's a lot of responsibility to lose other people's money. So each of us should think about that ourself.

[edelupolino]

...in USA sind wir etwas im minus nach dem schönen anstieg:

die shorts meinen wohl, der investor habe die 47 mio ohne sinn und verstand investiert!

Wir wissen, deren verstand ist durch geldgier und herzlosigkeit vernebelt...

[GuHu1]

http://www.businesswire.com/portal/site/google/?ndmViewId=ne…


http://seekingalpha.com/article/71557-biotech-stocks-sector-…

[GuHu1]

http://www.cnbc.com/id/15840232?video=706238523&play=1

http://www.cnbc.com/id/15840232?video=705894554&play=1

[GuHu1]

Antwort auf Beitrag Nr.: 33.829.595 von edelupolino am 07.04.08 19:26:14

hi ede,
ich denke da werden einige gewinne mitnehmen. nicht alle sind an langfristigen investments interesseiert und wer das risiko nicht mitgehen möchte macht halt kasse.

larry, noch an board?

[GuHu1]

den umfang des 483 problems kann ich schwer einschätzen, dazu ein repost aus dem IV:

Recs: 7 Repost: "483 - relax people" (byTooskookum4u)
In the interest of maintaining balance:

Tooskookum4u
Msg: 132679 of 178268 6/9/2007

483 - relax people...
483s run the table between paperwork issues (not all workstations have policy and procedure manuals next to them) to facility issues (improper air handling equipment) to maintenance plan issues (planned airhandling filter changes every 2 months instead of every 4 months) to product issues (product is not stable).

Fixing these issues can take from 10 minutes (copy policy manuals to a workstation desktop) to years (stability issues). I have never heard of any new facility receiving a first-inspection pass. When a NDA or BLA involve the inspection of a new facility, it is very common for the final CMC issues to be resolved in the last few days before the PDUFA date. The issuance of a 483 is consistent with this and would not hold up or delay approval unless it could not be resolved ahead of the approval date AND it was serious enough for the FDA to withhold drug approval (relatively rare) until the situation is fixed.

Resolution of certain minor 483s can be made conditions of approval of a drug, meaning resolution is NOT required before approval. I would guess more than half of new drug approvals for drugs produced out of a new facility have some outstanding manufacturing issues at the time of marketing approval.

Dendreon is producing drug for 9902b out of the NJ manufacturing facility. This was stated at the ASM. This means any 483 items are minor and would unlikely have caused any FDA approval delay -- especially a significant delay.

CRL can be resolved with either a class 1 or a class 2 response. Class 1 responses require the FDA to respond in 60 days. Class 2 responses require the FDA to respond in 6 months. The "class" of response is assigned by the FDA after the company submits their amended applications. In the case of minor manufacturing issues, it is almost always a class 1 (60 day) response.

The Provenge CRL would have the manufacturing issues added in to the letter because the FDA did not talk with Dendreon between the panel and the decision. Note that Dendreon said their formal (Type A) meeting with the FDA specified only efficacy data was necessary for approval. NOT efficacy and MANUFACTURING changes.

Relax...

1. Dr. Urdal said the issues are minor and David would never lie.
2. Dendreon is producing Provenge for the 9902b trial out of NJ, something the FDA would never allow if it was a serious problem.
3. The FDA said the only barrier to approval was additional survival data, not anything associated with manufacturing. This means Provenge would have been approved if the FDA would have followed its advisory panel.

Keep your eye on the ball here. Do not let the lawyers and their hedge fund friends keep you from writing Congress to demand they hold hearings into why the FDA did not follow its advisory panel vote. The decision to delay Provenge until another 80,000+ men die had nothing to do with science, data, or manufacturing issues. It was 100% politics and only a political effort will bring Provenge to market faster than 2009.

[edelupolino]

Antwort auf Beitrag Nr.: 33.841.115 von GuHu1 am 08.04.08 22:37:54

Hi GuHu,

interessante idee aus IV, wie Gold auch handeln könnte; auf diese weise könnte amerikanisches know-how gerettet und genutzt werden...:

Oncophage....Lesson LEARNED ?..
Antigenics' oncophage's acceptance by Russia while still awaiting approval by U.S. FDA shows how tide is turning.

Unless U.S. FDA wakes up we will lose another keystone business to foreign competition.

Congratulations to Antigenics for playing outside the box. Offshoring is becoming more relevant as FDA bumbles.

Is Mitch Gold listening? (April8,08; von binder)

[Larry_1]

Antwort auf Beitrag Nr.: 33.841.115 von GuHu1 am 08.04.08 22:37:54

klaro, ich bin noch investiert. Für mich zeigt der ChartTrend weiterhin nach oben.
Die kurzen Rücksetzer sind eigentlich völlig normal und für einen "gesunden" Anstieg auch notwendig.

Habe gerade mal wieder schöne Tagesgewinne bei Archea Biogas realisiert. Vor ein paar Tagen bei Escada

und warum: die Leute sind zur Zeit so richtig begeistert, wenn Sie was von "strategischen Investoren" hören, die eben in diese Unternehmen investieren wollen (und dann leider doch wieder einen Rückzieher machen)
good luck

[GuHu1]

Environmental Health & Safety Specialist
Pharmacologist
QC Assoc II - Biochemistry
Research Associate II - Analytics
Sr. QA Associate Quality Systems
Sr. Quality Computer Validation Specialist

wie gesagt, man sucht (2 neue positionen) und findet mitarbeiter bei dndn.

[edelupolino]

...das hat mich auch schon gewundert:

Why hasn't Sher been sued individually by
somebody or some group??? (IV, Rush2X)

[GuHu1]

werden wir morgen event. wieder grün sehen.

http://www.bloomberg.com/apps/news?pid=20601103&sid=ahn5vHH4…

[GuHu1]

auch das spricht für einen grünen di.

http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5599…

http://www.healthios.com/node/580

[hakur]

Antwort auf Beitrag Nr.: 33.884.421 von GuHu1 am 14.04.08 23:00:48

charttechnisch steht dem grünen di. nichts entgegen

so loong

[GuHu1]

Antwort auf Beitrag Nr.: 33.884.492 von hakur am 14.04.08 23:20:51

[edelupolino]

Antwort auf Beitrag Nr.: 33.884.354 von GuHu1 am 14.04.08 22:49:38

...hört sich wirklich nach "grün" an.

[NoSelters]

Huckman

http://www.cnbc.com/id/24127035?__source=RSS*blog*&par=RSS

[GuHu1]

http://www.fiercebiotech.com/story/optimistic-dendreon-revs-…

[Uptick08]

Antwort auf Beitrag Nr.: 33.884.421 von GuHu1 am 14.04.08 23:00:48

Ich gebe hier jedenfalls GAR KEIN STÜCK FREI..



Jetzt stimmt sogar das kurzfristige Chartbild wieder und Mr "Deep(Biotech)Pockets" (Danke für deinen Huckmann Beitrag, No Selters ) ist mit von der Partie.

Gott sei Dank hat der Hopp bisher keine Interesse gezeigt (GPC & Sygnis lassen im 'negativen' grüßen)...die alten ATH's sehen wir schneller als manch so'n shortie das wahr haben will.

Good trades & steady hands with ein super aufgestellten DNDN

[NoSelters]

http://www.pharmalot.com/2008/04/provenge-protest-planned-fo…

[Poppholz]

schaut von Euch einer auf den Kurs?

[hakur]

Antwort auf Beitrag Nr.: 33.920.334 von Poppholz am 18.04.08 16:40:17

nur nebenbei, falls DNDN über 5.80 schließt haben wir den Allzeit- Downtrend gebrochen.
Stelle später den Chart dazu rein falls die Zeit es erlaubt.

Kreuzt die Finger

so loong

[Uptick08]

Antwort auf Beitrag Nr.: 33.920.334 von Poppholz am 18.04.08 16:40:17

schaut von Euch einer auf den Kurs?

Nöööö erst ab 20$ wieder

[GuHu1]

Antwort auf Beitrag Nr.: 33.921.144 von Uptick08 am 18.04.08 17:50:16

kein grund zur panik.

http://advancedprostatecancer.net/?p=299

[GuHu1]

Antwort auf Beitrag Nr.: 33.920.371 von hakur am 18.04.08 16:43:02

hi hakur, $5,85 , geht doch.

[GuHu1]

09.04.08
Environmental Health & Safety Specialist
Pharmacologist
QC Assoc II - Biochemistry
Research Associate II - Analytics
Sr. QA Associate Quality Systems
Sr. Quality Computer Validation Specialist

__________________________________________
18.04.08
Environmental Health & Safety Specialist
Pharmacologist
Product Development Interns
Quality Assurance Manager NJ
Research Associate II - Analytics
Sr. QA Associate I/II
Sr. Quality Computer Validation Specialist
Sr. SAS Programmer (long term contract)

ts ts ts hat sich ja wieder etwas getan im hause dendreon

[hakur]

Antwort auf Beitrag Nr.: 33.920.371 von hakur am 18.04.08 16:43:02

habe ich im IV gefunden ;-)
spare zur späten Stunde mir die umständliche hochladerei des Charts .
Ist wirklich umständlich hier i8m WO, sorry muß ich mal sagen.

Hier der Link vom IV mit chart.
http://www1.investorvillage.com/smbd.asp?mb=971&mn=194130&pt…

War ein super close, hatte ich nicht so mit gerechnet. Dndn ist jetzt etwas überkauft, also nicht wundern wenns etwas stockt im weiteren Preis pro Aktie. Bin auf jeden Fall vorsichtig bullisch.
Schönes Wochende
so loong

Ps. speziell an Dich Sepp, liest sicher mit

[hakur]

Antwort auf Beitrag Nr.: 33.923.681 von GuHu1 am 18.04.08 22:32:36

hmmm.. ging fast etwas flott, aber schön isses
Hab nicht so recht damit gerechnet. UBS kann den Kurs anscheinend nicht mehr kontrollieren, könnte für Ihre geschorteten Aktien etwas teuer werden. Wenn eine positve Meldung kommt, wie Partnerschaft oder ganz zu schweigen eine vorzeitige Zulassung
können sie bei 20 + ihre geschortetetn Aktien einsammeln einsammln.

[GuHu1]

Antwort auf Beitrag Nr.: 33.923.814 von hakur am 18.04.08 22:59:08

thx für den chart HAKUR

[hakur]

Antwort auf Beitrag Nr.: 33.923.814 von hakur am 18.04.08 22:59:08

Olala, einmal einsammeln reicht ,
war wohl ein Freudscher Versprecher mit einer nachdrücklichen Aufforderung an UBS ...

[hakur]

Antwort auf Beitrag Nr.: 33.923.860 von hakur am 18.04.08 23:07:21

eben im IV einen passenden Beitrag zu den Shorts gefunden:

Re: Well, UBS evidently doesn't have much clout/ oops!... close @ 5.85 today....eom
UBS is having money problems...used to "jack" this down at will...higher this goes the bigger money problems they have here and the less they can do...they are trying to plug up the dam not only here... but with many of their positions...couldn't happen to a nicer bunch of guys. I say...UP THEIRS...cheers mw

[edelupolino]

Antwort auf Beitrag Nr.: 33.923.814 von hakur am 18.04.08 22:59:08

in der entsprechenden UBS-abteilung werden die nerven flattern und die köpfe rauchen, wie sie sich verhalten sollen...

...bei DEN riesigen verlusten, die sie auf ihrer HV vor kurzem vor wütenden Schweizer aktionären zugeben mussten!!...das vorstandspult wurde fast gestürmt!

würde denen glatt zutrauen, heimlich CALLS zu ordern, um sich abzusichern....

[Larry_1]

Klasse Schlußstand gestern abend.
Überhaupt waren die letzten 3 Tage allgemein supi, aber das habt Ihr ja selber erlebt.....

[Uptick08]

Antwort auf Beitrag Nr.: 33.925.132 von Larry_1 am 19.04.08 12:16:33

Sogar in AH trading "etwas mehr Bewegung" , und das an einen Freitag Nachmittag

http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…

Ich wiederhole mich ungerne, hier ist was im Busch

[GuHu1]

Provenge and Non Prostate Cancers
J Immunother. ;28:535-41 16224270 (P,S,E,B)

http://lib.bioinfo.pl/pmid:16224270

[My paper] Yi Wang, Mamoru Harada, Hirohisa Yano, Sachiko Ogasawara, Hiroko Takedatsu, Yoshimi Arima, Satoko Matsueda, Akira Yamada, Kyogo Itoh
Prostatic acid phosphatase (PAP) is one of the prostate-related antigens that are applicable to specific immunotherapy for patients with prostate cancer. In this study, we determined whether or not PAP could be a target molecule in specific immunotherapy for patients with nonprostate cancer. A variety of adenocarcinoma cell lines were examined for their PAP expression at the mRNA and protein levels by reverse transcription polymerase chain reaction and western blot analysis, respectively. Considerable percentages of colon, gastric, and breast cancer cell lines were found to be positive for PAP at both the mRNA and the protein levels. The PAP expression in cancer tissues was also confirmed by immunohistochemical staining. In addition, we examined whether cancer-reactive cytotoxic T lymphocytes (CTLs) could be induced from peripheral blood mononuclear cells (PBMCs) of human leukocyte antigen (HLA) A24+ nonprostate cancer patients by in vitro stimulation with a PAP peptide. As a result, tumor-specific CTLs could be induced from the PBMCs of HLA-A24+ colon and gastric cancer patients. Their cytotoxicity against HLA-A24+ cancer cells was dependent on PAP peptide-specific and CD8+ T cells. These findings indicate that PAP could be a target molecule in specific immunotherapy for patients with nonprostate adenocarcinomas including colon and gastric cancers.

http://www.investorvillage.com/smbd.asp?mb=971&mn=194259&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 33.927.700 von GuHu1 am 20.04.08 12:34:34

Wäre zu schön um wahr zu werden, Provenge hilft bei vielen Krebsarten und wir werden reich!
Na, ja hoffen darf man ja, mein Bestand habe ich auf 2000 Stück aufgestockt!

[Uptick08]

Antwort auf Beitrag Nr.: 33.931.467 von Magnetfeldfredy am 21.04.08 12:07:38

Reich mit 2000 Stk?

Welche Kursziel hast Du im Sinn

[GuHu1]

Antwort auf Beitrag Nr.: 33.931.467 von Magnetfeldfredy am 21.04.08 12:07:38

na na, dndn muss erst entsprechende daten am besten zum interims look (Q3/Q4 2008), spätetens zum abschluss der laufenden studie (Q3/Q4 2009)abliefern.

haupt augenmerk liegt auf provenge.
__________________

http://seekingalpha.com/article/73065-dendreon-the-fda-s-com…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 33.934.649 von Uptick08 am 21.04.08 17:59:01

Kursziel hab ich kein Spezielles, sonst gehts eh wieder in den Graben!
Aber bei positiven Daten von Provenge und der Zulassung könnte ich mir den Imclone Kurs als Zielkurs schon vorstellen, aber ich staple lieber tief, hab nämlich die Pleite mit GPC live miterlebt!
Und reich, damit meine ich happy und froh, daß vielleicht vielen Kranken geholfen werden kann!

[GuHu1]

Antwort auf Beitrag Nr.: 33.937.387 von Magnetfeldfredy am 21.04.08 22:52:34

Und reich, damit meine ich happy und froh, daß vielleicht vielen Kranken geholfen werden kann!

genau, reich ist relativ.

http://files.shareholder.com/downloads/DNDN/290791466x0xS120…

wird ede überhaupt nicht toll finden.

[hakur]

neuen akzuellen Chart auf IV gefunden ;-)
nimmt mir die Arbeit ab.

so loong

http://www1.investorvillage.com/smbd.asp?mb=971&mn=194697&pt…

[hakur]

übrigens denke das ist für uns alle eine nervige Erscheinung dass der Euro sein Alltime Hoch erreicht hat.
Gibt jedoch einen Hoffnungsschimmer von der Chartfront. Der Euro zum Dollar befindet sich seit Mitte März in einem steigenden Keil, im Gegensatz zum fallenden Keil der bekanntlich bullisch ist, ein bärisches Merkmal!!
"So there is hope" von der Devisen- Front

[Uptick08]

Antwort auf Beitrag Nr.: 33.937.387 von Magnetfeldfredy am 21.04.08 22:52:34

bin voll und ganz bei dir

[edelupolino]

Antwort auf Beitrag Nr.: 33.947.626 von GuHu1 am 22.04.08 23:28:15

völlig richtig, dass ich Golds verkäufe wieder einmal nicht gutheißen kann -obwohl letztes jahr nach der explosiven aufwärtsbewegung hab ich ihm die gewinnmitnahme gegönnt!

aber jetzt müsste er flagge zeigen!!

(ich hoffe, er hat die paar mäuse NUR gebraucht um hier und da geschenke an familienmitglieder verteilen zu können; denn kinder, z.b. kosten so einiges.)

[edelupolino]

Antwort auf Beitrag Nr.: 33.947.744 von hakur am 23.04.08 00:06:32

bei beiden charts:
sehr spannende zeiten, in denen wir leben!!

[GuHu1]

Antwort auf Beitrag Nr.: 33.950.525 von edelupolino am 23.04.08 12:07:09

in diesem jahr kam nach den verkäufen (relativ kleine stückzahl) immer min. eine positive news.

http://www.investorvillage.com/smbd.asp?mb=971&mn=194786&pt=…

Re: DMC and "alternative pathway"/p3
>>do you know if the DMC only reports at a prespecified interim <<

Yes. DMC only reports a prespecified interim, and DMC doesn't convene until the prespecified inteirm analysis is done. Therefore, the most likely timing for an ONXX type of news release should be 2H08. The question is why DNDN scheduled a meeting in May with FDA ( http://www1.investorvillage.com/smbd.asp?mb=971&mn=190938&pt… ) assuming the rumor is true. Perhaps there is a very remote likelihood that given how delayed FDA has agreed to the SPA amendment, that the DMC has convened to review the 180-death efficacy analysis, which is what Gold meant a "Free shot on goal".

nun ja, äußerst spekulativ aber die meinungen der stat. guys im thread sind interessant.
________________

http://www.bloomberg.com/apps/news?pid=20601124&sid=a6bvYcew…

[edelupolino]

Antwort auf Beitrag Nr.: 33.957.365 von GuHu1 am 23.04.08 22:20:55

...der eine oder andere geht hart mit Gold ins gericht (IV):

If Gold is selling any amount of stock
no matter how small, he either sees no chance of Provenge approval, he is broke and needs the money, or is an idiot. It could be argued a person on his salary if broke is also an idiot. So you have two choices, either Provenge will never be approved or Gold is an idiot. As a long I see both as negatives. This is the CEO of a company,who if Provenge is approved could see stock go to $30 and most likely higher. So the sale of even 1000 shares at these numbers is like throwing away $50,000! It makes no sense if the CEO see any hope of Provenge approval.

Surely even Gold knows his selling hurts every shareholder, cause it creates doubt as to Provenge and his intelligence. This is the same guy who sold before approval decision, so he isnt a total moron.

Time to buy more puts to hedge my shares.

4/24/2008 7:58:29, by soonenough

[GuHu1]

The Annual Meeting of Stockholders (the “Annual Meeting”) of Dendreon Corporation, a Delaware corporation (the “Company”) will be held on Wednesday, June 4, 2008, at 9:00 a.m., local time....

http://investor.dendreon.com/secfiling.cfm?filingid=950134-0…

[GuHu1]

http://www.washingtonceo.com/home/story-display/article/312/…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 33.981.463 von GuHu1 am 27.04.08 23:16:17

Sehr interessanter Beitrag!

[edelupolino]

Antwort auf Beitrag Nr.: 33.981.463 von GuHu1 am 27.04.08 23:16:17

...auch die anmerkungen von lesern dieses artikels sind lesenswert.

[bernie55]

FDA Drug Oversight

The slow rate of drug approvals, with Andrew Von Eschenbach, FDA

http://www.cnbc.com/id/15840232?video=724593015&play=1

[edelupolino]

Antwort auf Beitrag Nr.: 33.991.197 von bernie55 am 29.04.08 10:53:28

Maria ist viel zu höflich oder einfach uninformiert -oder hat keine verwandten mit PC.

Die harten (v.E. überraschenden) fragen fehlen in diesem interview...

Vielleicht würde Maria dann aber ihren job verlieren.

[GuHu1]

Antwort auf Beitrag Nr.: 33.984.559 von edelupolino am 28.04.08 13:48:50

stimmt ede :

Kerry Donahue said,
Sunday, 27-04-08 20:10 CareToLive continues to try to bring attention to the misdeeds of the FDA relative to Provenge.

On Friday May 30th demonstrations protesting the FDA decision will be held in numerous cities including Seattle (outside FDA offices in Bothell).

Other sites include Chicago (ASCO), Dearborn (Dingell's Office), Atlanta (FDA offices), Cleveland (public Square), Philly (outside FDA offices), Madison Wisconsin (Capitol building), New York, NY (MSK), Maitland Florida (FDA offices)

CareToLive filed a Citizen Petition on July 27, 2007 asking the FDA to reconsider this failure to approve Provenge. The FDA was to properly respond by January 24, 2008. Instead Jesse Goodman the head of the CBER division of the FDA said they needed more time, while 83 men a day die without access. Two FDA employees then told CareToLive that a committee had been formed and they were actively considering the petition along with the comments submitted (over 200 comments in support). That was two months ago and now appears to have been but a legal maneuver done without concern for the patients who sit in wait and have no viable treatment options.

Proof that Provenge was purposely sabotaged by Richard Pazdur, an FDA employee, is in the documents that were requested in a Freedom of Information Act request made by CareToLive. The FDA refuses to turn them over to the public.

The FDA commissioner knows what happened was wrong, but he refuses to fix it.

[edelupolino]

Antwort auf Beitrag Nr.: 33.995.981 von GuHu1 am 29.04.08 18:38:44

Ich muss immer wieder sagen, wie klasse ich die aktionen der Us-boys'n'girls finde: öffentlichkeit kann druck erzeugen und all diese leute im sumpf (Pazdur etc) nervös machen...

[Larry_1]

Habe mich gestern mal (vorübergehend)von DNDN verabschiedet.
Die dümpelt mir zur Zeit zuviel

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 34.000.069 von Larry_1 am 30.04.08 10:51:51

Ist gefährlich, am 6. Mai Präsentation!

[GuHu1]

Antwort auf Beitrag Nr.: 34.003.532 von Magnetfeldfredy am 30.04.08 16:39:16

ja am 06 + am 13 + am 19 May wird präsentiert.

Deutsche Bank 33rd Annual Health Care Conference
InterContinental Boston
Tuesday, May 6, 2008
8:50 a.m. ET

Bank of America Health Care Conference
Four Seasons Hotel, Las Vegas
Tuesday, May13, 2008
11:00 a.m. ET

Rodman & Renshaw 5th Annual Global Health Care Conference
Le Meridien Beach Plaza Hotel, Monte Carlo
Monday, May 19, 2008
9:30 a.m. ET

@larry
weiterhin glückauf

[Poppholz]

Antwort auf Beitrag Nr.: 34.000.069 von Larry_1 am 30.04.08 10:51:51

ich bleibe drin.

Wenn ich aussteige, dann verpasse ich den Zug bestimmt und dann würde ich mich nur ärgern.

... und das möchte ich vermeiden.

[GuHu1]

http://www.philly.com/inquirer/magazine/16947521.html

[Uptick08]

The Seattle-based company said Thursday that it was selling about 8 million shares along with warrants to an institutional investor. The deal was expected to garner Dendreon some $47 million.


Ist diese Aktion bereits vollendet oder ist das der teil von Kuchen von der Privatier der nicht genannt werden möchte

[GuHu1]

Antwort auf Beitrag Nr.: 34.017.197 von Uptick08 am 02.05.08 16:37:31

http://files.shareholder.com/downloads/DNDN/299369585x0xS110…

[Larry_1]

Antwort auf Beitrag Nr.: 34.007.544 von Poppholz am 01.05.08 00:27:53

das ist ja auch in Ordnung, nur der "Zug" wird nicht so schnell anfahren, das Du nicht mehr reinkommst (außer bei Übernahme)
Ich lass mein Geld derweil woanders "schaffen"
Schönes WE all

[GuHu1]

http://www.investorvillage.com/mbthread.asp?mb=971&pm=196226…

Deutsche Bank call with Gold


CD54- "We can measure that", then we send it to the patient. (Again this is confirmation DNDN has measured CD54 upregulation in ALL IMPACT patients).

9901/9902a- "All the power came at the tail of those curves" (Is DNDN really sure of the interim? Conversely DNDN must be really certain of the final because they cut off the end of the curve.)

Why we are encouraged by IMPACT's design - similar in design to 9901 study. Of 225 pts on integrated analysis, there were 164 death events. For interim on IMPACT we will have more than 164 events and as a result the interim is reasonably well powered to achieve its hurdle. IMPACT 70 sites in N. America (including Canada) over 500 men, basing assumptions off of integrated 9901/9902a. The final analysis is always better powered than the interim and the events are 304. (I do not know what to make of this except that DNDN is supremely confident on the final.)

There is company in Boston that is focused only on trp-p8. (Pretty interesting)

We appreciate the patient advocacy community.

We have not given away the rights to this product. We have made a conscious decision to keep it for ourselves and maximize shareholder value for the long term.

Present data on trp-p8 later on in May at the American neurological Association meeting. Start two new Provenge trials. (It sounds like that is coming soon). Second half of this year we will have the interim.

There has not been any data like this for 2 decades. PC advocacy groups saw this; this is similar to what happened with breast cancer 20 years ago. Regardless of what happens to DNDN this is good.

Provenge's benefit is still present up to two years out. (this is after the initial doses).

Big pharma is interested and so are European pharmas. Our key focus is on FDA approval and then parallel partnering, Euro partnering.

Competitive landscape is getting more complex. AZN had interesting PH2 data. Most of the other development work is in 2nd stage and we are positioned as front line prior to Taxotere and that is where we differ.

We are always interested in combinations....VEGF....but you have to worry about toxicity.

CD54- Can we prospectively define it...aka ICAM-1. Potency/upregulation directly correlated to survival. FDA very interested. CD54 independent of prognostic factors. You can determine how much cd54 upreg they had and do they need another dose to push them up higher in the curves.

[NoSelters]

Quartalsbericht:


Dendreon Reports First Quarter 2008 Financial Results

SEATTLE, May 8, 2008 – Dendreon Corporation (Nasdaq: DNDN) today reported results for the first quarter ended March 31, 2008. Revenue for the first quarter of 2008 was $31,000 compared to $80,000 for the quarter ended March 31, 2007.

Dendreon's total operating expenses for the three months ended March 31, 2008 were $19.2 million compared to $32.0 million for the same period in 2007. The significant reduction primarily relates to a decrease of $6.5 million associated with purchases of commercial scale quantities of the antigen used in connection with Dendreon's lead investigational product, Provenge® (sipuleucel-T) as well as reduced expenses associated with the IMPACT clinical trial which completed enrollment in October of 2007. The net loss for the quarter ended March 31, 2008 was $19.5 million, or $0.23 per share compared to a net loss for the same quarter of 2007 of $30.9 million, or $0.38 per share, which includes $0.08 per share associated with commercial antigen purchases. Cash, cash equivalents, short-term, and long-term investments at March 31, 2008 totaled $99.5 million compared to $120.6 million at December 31, 2007. Subsequent to March 31, 2008, the Company received approximately $46 million of net proceeds from the registered direct offering that closed on April 8, 2008.

"We had a very productive first quarter, highlighted by our amended Special Protocol Assessment (SPA) for our ongoing Phase 3 clinical study that accelerates our timeline for final results by a year. At Dendreon, our primary focus remains on providing the FDA with the additional clinical data that it needs to support the approval of PROVENGE so that we may offer this promising therapy to the many men with prostate cancer who currently have few appealing treatment options," stated Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We remain in line with our previous financial and operational guidance for 2008, and as a result of our recent financing, we expect to have sufficient resources to carry us through the final analysis of our Phase 3 IMPACT study."

Recent Events:

The FDA agreed to amend the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) SPA, accelerating the expected timeline for final results from the study by approximately one year while maintaining comparable power to the previous SPA. In addition, the FDA reconfirmed that either a positive interim or final analysis of survival would support licensure and enable Dendreon to amend the Company's biologics license application for PROVENGE.

Completed a registered direct stock offering resulting in the receipt of net proceeds of approximately $46 million. With this cash infusion, the Company has adequate resources to complete the IMPACT trial and finance operations through the final analysis of that trial.

Presented clinical data from a Phase 1 trial of Neuvenge™ (lapuleucel-T) demonstrating that the Active Cellular Immunotherapy, which is based on the same Antigen Delivery Cassette™ technology as PROVENGE, may not only have potential clinical benefit in breast cancer, but also in ovarian and colorectal cancers. These data were presented in April at the American Association for Cancer Research annual meeting.

In lieu of Dendreon's regularly scheduled quarterly conference call, the Company will present at several upcoming investor conferences that will be webcast, two of which are later this month and include:

Bank of America Health Care Conference on May 13, 2008

The Rodman & Renshaw 5th Annual Global Healthcare Conference on May 19, 2008

[GuHu1]

http://blog.seattlepi.nwsource.com/thelifesciencesblog/archi…
____

http://www.investorvillage.com/smbd.asp?mb=971&mn=196599&pt=…

Re: Brean Murray
<Brean Murray believes that the IMPACT trial will fail because it will be properly randomized and therefore will not be as imbalanced in its randomization as was the original D9901 trial. DNDN also amended its SPA to include all HRPC patients, regardless of Gleason score, providing an even more heterogeneous patient population and thus raising the bar even higher... for a therapeutic that firm believes has little to no efficacy>

This Aschoff's argument based on Gleason score was brought up by a recent poster with the moniker the_real_squishy or some such. The problem with it is that the FDA statisticians already checked it out in their sensitivity analysis. The Cox model V in Table 9 of the Statistical Review explicitly checked to see if any putative GS imbalance could imply better survival benefit for the treatment arm. The result was a resounding no since after correction, the survival benefit remained statistically significant.

I was actually expecting the next step for Squishy to take was to assert that because IMPACT stratifies for Gleason Scores that IMPACT would fail. But he left quickly after seeing his argument pointed out short. The current Aschoff's variation of "more heterogeneous patient population" is somewhat more innovative but again just as wrong. All evidence in the data pointed to the survival benefit being fairly uniform across all Gleason Scores. If this is all Aschoff could muster to blabber "a therapeutic that firm believes has little to no efficacy", things look good!

[edelupolino]

Neue hoffnung im IV-forum wg Obama:

In response to msg 196836 by binder
Recs: 3
Re: When Provenge is approved....?......Approaching Proverbial Fork in Road
Again, should Oboma become the democratic candidate, I believe the Provenge saga will be a good way for him to illustrate the old way of doing things in Washington vs his articulated desire to minimize the role of lobiests in Washington decision making. Provenge story is tailor made for his campaign. We have all noted how this could be the plot of a suspense filled new movie or book or better yet a Pulizer (prize for investigative jurnalisum)... but better yet, why not make the story the centerpiece of a Presidential campaign.

...sie sollten Obama darauf hinweisen, dass schwarze eher zu PC neigen als weiße! (..oder wäre das eine zu rassistische idee, die er nicht beachten sollte???)

Frohe Pfingsten
Ede long


PS: hab vor monaten gelesen, dass O. noch mehr knete von lobbyisten erhält als Cli!!...man kann nur hoffen von den richtigen lobby-tricksern...

[GuHu1]

aus dem IV:

Prostate Cancer
Death threats—ostensibly from prostate cancer patients—were sent to several doctors who helped persuade the FDA not to approve a new drug, Provenge, which a small study suggested might prolong the survival of men with advanced cancer. But the FDA may reconsider its 2007 decision after the results of a larger clinical trial are announced this fall. If the drug—a vaccine to stimulate the body’s own immune system to fight the cancer—does work, “that would be a real sea change, because immunotherapy in general has not been successful in any cancers,” says Philip Kantoff, professor of medicine at Harvard University and the leader of Dana-Farber’s prostate cancer program.

While older patients with other cancers are often undertreated, a growing census holds that “there is a significant amount of overtreatment” in older men with localized prostate cancer, says Theodore DeWeese, M.D., chair of the Department of Radiation Oncology and Molecular Radiation at the Johns Hopkins School of Medicine in Baltimore. He and other oncologists say older men with low-grade prostate cancer—and especially men with another disease—are good candidates for “watchful waiting.” That means having an annual biopsy, testing levels of PSA—a protein that can signal cancer—and forgoing treatment unless those tests indicate some danger.

http://bulletin.aarp.org/yourhealth/diseases/articles/good_n…

[hakur]

Hier mal wieder ein Chart update.

War schon ziemlich frustriert nachdem der letzte große fallende Keil sich "nur" bis vorläufige $5,80 auflöste. Hatte etwas mehr erwartet. Möglicherweise kommt das jetzt zeitversetzt mit dem kleinen grünen fallenden Keil der sich wenn es optimal läuft die nächsten Tage nach Norden auflösen sollte. Theoretisch gibts die Möglichkeit dass der Kurs noch die $5.- testet, gehe eher nicht davon aus.

Wird auf jedenfall mal wieder spannend. Auf dass die Shorts endlich getoastet werden


Ps. Guhu, danke für Deine aufmunternden Worte!

[edelupolino]

Antwort auf Beitrag Nr.: 34.078.444 von hakur am 12.05.08 22:59:27

Hi hakur,
auf deinem informativen chart sieht man, gegen welche charttechn. schwierigkeiten dndn zu kämpfen hat:
den alltime-downtrend zu überwinden ist kein pappenstiel, besonders wenn die wirklichkeit (kleine verkäufe des chefs etc) dem noch zuarbeitet. Von daher war der abpraller bei ca 5,80 eher zu erwarten -gegen alle unsere hoffnungen.

Aber: NEUES SPIEL neues glück - ändert sich im augenblick: dieser wahre spruch eines zirkusgauklers aus meiner kindheit ist ewig anwendbar; und wenn bald positive nachrichten kommen (oder erst im herbst), sieht alles wieder anders aus.

Vielleicht arbeitet sich der kurs ja jetzt schon höher...
Ciao Ede

[hakur]

Antwort auf Beitrag Nr.: 34.079.803 von edelupolino am 13.05.08 10:06:23

NEUES SPIEL neues glück - ändert sich im augenblick

Ede an deinem Wahlspruch scheint was dra zu sein.
Sieht so aus als ob der Toaster vorgeglüht wird.
Let`s see

so loong

Ps. Hab mal charttechnisch so getan als ob die Zulassung klar wäre und eine Prognose zeichnerisch versucht. Das Ergebniss machte mich sprachlos. Wie bei einem Spiel der Gaukler.
Wie gesagt wie bei einem Spiel.

[NoSelters]

Huckman....

http://www.cnbc.com/id/24597727

[edelupolino]

Antwort auf Beitrag Nr.: 34.084.435 von hakur am 13.05.08 18:47:36

Hi hakur,
jetzt bewegt sich der kurs schon richtung alltime-downtrend!!
Wenn er den knackt -könnte auch beim ersten mal nur versuchsweise sein- öffne ich mir schon mal ein leckeres weizenbier (hell, wegen der symbolik.

Was nach dem durchstoßen der linie passieren kann...nicht auszudenken für uns alle.

Hab heute morgen leider gepennt; wollte erst kaufen, um bei der trendlinie wieder zu verkaufen (weizen!! ohne sucht!)- bin aber angenehm überrascht.

Ciao Ede

[edelupolino]

Antwort auf Beitrag Nr.: 34.084.613 von NoSelters am 13.05.08 19:08:54

Hi @all,
aus dem angegebenen artikel:

How to Win the War Against Cancer
By LANCE ARMSTRONG
May 13, 2008; Page A17

"What a difference a day makes." It's a phrase we often hear, and like many clichés, it has some elements of truth. A single day can turn the tide and lead to victory.

And today, the fifth annual LIVESTRONG Day, the Lance Armstrong Foundation is asking every American to join our united front against cancer and help make beating this disease a national priority.

Cancer affects every person in this country. Twelve million Americans have the disease; this year alone nearly 600,000 lives will be lost to it, while 1.4 million of us will get the dreaded diagnosis from our doctors. In some communities, death rates are substantially higher than in others.

"Of all the forms of inequality," Martin Luther King Jr. once said, "injustice in health care is the most shocking and inhumane." Cancer deaths are shamefully high among minorities and the poor because many lack access to life-saving prevention and treatment measures....

...und hier liegt der hase im pfeffer:

...Government must streamline the laborious process of getting breakthroughs from lab to clinic. We can cut out red tape of questionable necessity that discourages innovation in the private sector.....

Vielleicht geht das ja mit einer neuen regierung, die (hoffentlich) keine Pharma-Lobby bedienen muss.
Ede

[GuHu1]

http://blog.seattlepi.nwsource.com/thelifesciencesblog/archi…

[GuHu1]

Antwort auf Beitrag Nr.: 34.084.435 von hakur am 13.05.08 18:47:36

hi hakur,

heute wird um die $5,50 gerungen, bin gespannt wo wir schließen.

[NoSelters]

Short Int. -5,18 %

http://www.shortsqueeze.com/?symbol=dndn&submit=Short+Quote%…

[hakur]

Antwort auf Beitrag Nr.: 34.095.117 von GuHu1 am 14.05.08 21:10:28

wird wohl nichts mit $5.50, ist kein Beinbruch sieht gut aus.
Übrigens die Marke welche liegt heute bei $5.58 morgen *$5.56
Sollte bald machbar sein.
Die Shorts sollten sich dann eine kältere Aktie aussuchen.
so loong

[GuHu1]

http://vfcsstockhouse.blogspot.com/2008/05/dndn-in-news-agai…

[GuHu1]

soviel zu den gerüchten des users caseystarman über die cancelled provenge/frovenge trials im IV.
dazu aus dem IV :

Reply from dndn IR
In answer to your question, no PROVENGE programs or trials have been cancelled. We remain on track to complete the interim analysis of the data from the IMPACT trial in the second half of this year and the final analysis in 2009. We have however recently encountered a supply issue with one of the materials used in the production of the product from frozen precursors. This is only limited to the frozen product and will not affect the manufacture of PROVENGE nor the outcome or timing of the Phase 3 IMPACT trial. We are working diligently with commercial suppliers of the material to remedy the issue so that patients whose cancer progresses may have access to the frozen form of PROVENGE should
they choose this course of treatment.

[edelupolino]

Antwort auf Beitrag Nr.: 34.136.449 von GuHu1 am 20.05.08 19:33:30

...für die übervorsichtigen hört sich "supply issue" natürlich abschreckend an;
der gestrige schlusskurs war allerdings HÖHER.

[edelupolino]

...hat proprovenge recht, oder ist er nachtragend und unmenschlich?

Author: proprovenge
a few observations
Nice pre market. Looks like cockroaches are not yet capping. In the past a pre market cap was used.
My spec is that they wish a rise so that they can cap & take it down to make more money. Every day at the close there is a block about 2 to 4 cents above the last price. Looks like every day we have a day trader who sells all day & then at the close buys back his position. On CNN TV a short while ago they talked about the treatment for Senator Kennedy. radiation & chemo. What I found interesting is that they said if this failed there might be an experimental vaccine. Here is a Senator who hurt our cause. Will serve him right if he can't get access to a vaccine that he has prevented to come to market.

[GuHu1]

hi ede,

was dachtest du denn was einflussreiche leute alles bekommen wenn der arsch auf grundeis geht.

[GuHu1]

http://sev.prnewswire.com/health-care-hospitals/20080521/AQW…

[hakur]

Hoffe das dies gestern ein klassischer Sell-off war.
Ist am Tagestief vom 11.Mai 2007 abgeprallt.
Gehe im Moment davon aus, dass da gewisse "Kräfte" Stopps abgegriffen haben. Möglicherweise ist denen von irgentwelchen News etwas bekannt und haben sich für Ihre Shorteindeckung schnell noch Aktien welche auf Pump gekauft sind billigst geholt.
- "Eine Interpretation von mir"-

so loong

Ps. Schönen Feiertag!

[edelupolino]

Antwort auf Beitrag Nr.: 34.149.847 von hakur am 22.05.08 11:45:30

after hours +0,07!

@ GuHu: neben der standartbehandlung haben sie dies mit ihm vor (Provenge wurd nicht erwähnt):

There has been some recent progress toward new treatments for malignant gliomas, Wen and others said. One new option still being tested is Avastin, a drug meant to cut off a tumor's blood supply. ( By Carey Goldberg and Stephen Smith
Globe Staff / May 21, 2008)

[GuHu1]

http://www.businessweek.com/magazine/content/08_22/b40860004…

http://www.cbsnews.com/stories/2008/05/21/eveningnews/main41…

[GuHu1]

die lassen nicht locker, obs was hilft?

http://seattle.bizjournals.com/seattle/stories/2008/05/19/da…

[edelupolino]

Antwort auf Beitrag Nr.: 34.154.292 von GuHu1 am 22.05.08 20:30:37

...steter tropfen höhlt den stein...

und steter kampf hilft den kranken gegen die FDA!
(da läuft ja wirklich ne menge an aktionen und berichten!)

[GuHu1]

@ede

18.04.2008

Environmental Health & Safety Specialist
Pharmacologist
Product Development Interns
Quality Assurance Manager NJ
Research Associate II - Analytics
Sr. QA Associate I/II
Sr. Quality Computer Validation Specialist
Sr. SAS Programmer (long term contract)
__________________________________________
22.05.2008

Clinical Documentation Coordinator
Pharmacologist
Product Development
Quality Assurance Manager
Research Associate II - Analytics
Sr. QA Associate I/II
Sr. Quality Computer Validation Specialist
Sr. SAS Programmer (long term contract)

[edelupolino]

Antwort auf Beitrag Nr.: 34.154.643 von GuHu1 am 22.05.08 21:16:52

die wörter "long term contract" signalisieren optimismus und siegeswillen!

[Uptick08]

Antwort auf Beitrag Nr.: 34.154.292 von GuHu1 am 22.05.08 20:30:37

Tja, basic human & patient rights... das finde ich toll das sie immer noch so 'dicht' dranbleiben

[GuHu1]

@uptick
die ziehen das durch und halten somit das thema in der öffentlichkeit.
überzeugen muss provenge, erste hürde interims lock q3/4 2008 oder wenns nicht ausreicht final lock q3/4 2009.
da keiner die "hürde" wirklich kennt, bleibt viel raum für spekulationen.

[GuHu1]

Scientists find new cancer vaccine target
Friday, 23 May 2008 08:40
Scientists have found unique targets for cancer vaccine Printer friendly version Cancer Research UK scientists have made a breakthrough in the development of new therapies, that have fewer side effects, in the treatment of the disease.

A unique protein – or 'tag' - found by the scientists could be used in a vaccine therapy to help the patient's own immune system to identify cancer cells and attack them, research published in the Journal of Clinical Investigation claims.

Lead author, Dr Caetano Reis e Sousa, said: "Vaccines work by triggering an army of immune cells, called T cells, to attack potentially dangerous foreign molecules, like those found on pathogens. Dendritic cells are the messengers, telling the T cells who to attack.

"We have now found a tag on dendritic cells – called DNGR-1 – which can be targeted by vaccines.

"Vaccines will carry a sample of the offending molecule and deliver it to DNGR-1 on the dendritic cells. The dendritic cell in turn will present the molecule to the armies of T cells and instruct them to attack."

Scientists have been searching for such a tag since dendritic cells were first discovered in 1973, but have only found ones that also exist on other types of cells.

Finding a completely unique tag is important as it cannot confuse the immune cells into attacking the wrong molecules.

Therapeutic cancer vaccines, developed to treat patients who already have cancer rather than act as a preventative measure, are a relatively new area of research but several are in development.

However, getting approval for these vaccines is proving difficult.

Biotechnology company Antigenics announced in April that it has received approval in Russia for its kidney cancer vaccine Oncophage – a world first - while Dendreon is still trying to get US approval for its prostate cancer vaccine Provenge.

[GuHu1]

Selected comments from the life sciences Blog -- Echoes of Provenge in cancer chief's comments

http://blog.seattlepi.nwsource.com/thelifesciencesblog/archi…

Posted by unregistered user at 5/22/08 4:35 p.m. #131352

Pazdur's answer to the first question above smacks of someone who is very egotistical at the least and a smart mouth to boot. Does he have any respect for other people at all?

That panel of experts that was convened to review Provenge consisted of some very highly qualified and well-reknowned researchers and physicians.

When Pazdur and his cohorts convened their own special behind-closed-doors meeting after the AC panel, they literally dissed those experts. Surely such experts may think twice before taking a seat on another panel.

The FDA is broken. It's time for resignations and replacements.

*********

Posted by inhumane fda at 5/22/08 6:06 p.m. #131386

There is absolutely no doubt that the good Doctor Pazdur has gone on the offensive regarding Provenge. He won't mention Provenge specifically because the FDA PR staff of 20 persons has told him if he mentions it directly it just helps the Provenge advocates cause.

The FDA has good, highly paid PR peope and good attorneys for which they pay millions of tax payer dollars to each year, to protect the massive egos of those like Dr. Pazdurs.

Don't take my word for it just listen to the FDA who in an internal self assessment report ADMITTED that they lack the ability to asses new and innovatove treatments...which is exactly the reason for the AC panels.

But of course Pazdur is so much smartter than all the experts and if his ambition and thirst for power is best fed by sabotaging a treatment for terminal patients so be it. This is a "dcotor" renowned for not wanting to have to physically touch his patients.

He lacks empathy and any any feling for patients and their families. He is cold and clculating and until he is fired or resigns wil contune to assure that the FDA WILL REMAIN THE fEDERAL DINOSAUER AGENECY

*********

Posted by Gipper69 at 5/22/08 6:35 p.m. #131392

What bilge! When the committe meets they vote in response to a question regarding safety and effecacy. Apparently in the case of provenge, 2 committee members wrote to the FDA concerning their vote. Since the other 15 panel members did not write followups, their votes were completely ignored.
If I were they, I'd refuse to sit on another panel. I'd tell this lying, arrogant, male member to find another dupe to waste their time. In the history of advisory panels, over 98% of the time going into this panel, the FDA adopted the panel's recommendation. After the committee met and voted, millions of shares of DNDN were sold short despite the historical near certanty of approval. No one goes all in unless the deck is stacked. The FDA was never going to approve provenge no matter what the committee did.

*********
Posted by unregistered user at 5/22/08 6:51 p.m. 131394

Dr. Pazdur is lying. Period. Dr Howard Scher led the charge to get the FDA to reject the overwhelming recommendation by the Advisory Committee to approve Provenge. He had many shady connections that led to a bipartisan group of Congressmen to request a formal investigation.

What the Congressmen writing the request(eventually about 15 signed on- and now a US Senator is getting involved in some way) found most egregious was that this Dr Scher, while fighting to defeat Provenge, was in fact an upper level executive with Proquest Investments. Proquest Investments, at the time of the Advisory Committee meeting for Provenge which Dr Scher was on, was heavily invested in Novacea(NOVC) to the tune of several hundred million dollars. Novacea was potentially a direct competitor to Provenge/DNDN. Additionally, two weeks after the FDA rejected Provenge/DNDN, Novacea signed a deal worth almost $500 Million with Bristol-Meyer or Sanofi(I forget which one). Novacea's ongoing trial for prostate cancer has since been halted as patients on the treatment arm have been dying faster than the pacebo arm.

Additionally, Pazdur has an extremely close relationship with Dr Scher. And, as it turns out, both have very close relationships to Michael Milken, convicted former junk bond king, prostate cancer survivor himself and chairman of the Prostate Cancer Foundation(PCF). This is where it gets scary. PCF/MILKEN started Proquest Investments as an investment vehicle for cancer therapies but never invested in DNDN/provenge but did invest in Novacea. Milken is banned for life from securities so you won't find him on the BOD for Proquest. But the most of the BOD for Proquest Investments is also on the BOD for PCF.

Pazdur is not a bungling bureaucrat. At best he knows full well Provenge "probably" works and is a very benign therapy but just doesn't give a damn about dying men. At worst, like Dr Scher, he is profiting by some form of secondary gain be it ego or money. But Pazdur and the FDA will not come clean on their own.

*********

Posted by unregistered user at 5/22/08 7:09 p.m. #131400

An all too typical response by Mr. Pazdur(you don't deserve to be in medicine)in this litigious and profit driven system that puts the brake on developmental therapies is "people will die" from unsafe, unproven meds. If you look at just one example, the advocacy group Abigail Alliance(AA) you will see they have in the past advocated access to a total of eight different end-stage cancer therapies in the past. ALL eight were eventually approved but spent years wallowing in the process out of reach of dying patients. This has some very significant implications. First is that, while a few hundred may have died from a Vioxx(just another COX-2 inhibitor for non lifethreatening bone pain), how many died prematurely because they didn't have access to any one of these eight meds advocated by AA. The number is likely in the hundreds of thousands if not millions. Why don't we particularly care about this? Again, in our system, a Sin of Omission(like Provenge which Pazdur is talking about) is much more palatable than one of Commission(like Vioxx). This is why the FDA can do this without an outcry. Now the FDA will use a specious argument that these meds can be made available in the experimental stage to the dying patient and their physician thru the "Compassionate Use" program. But since this program requires the drug manufacturer, which is usually an innovative but small and cash poor company, to foot 100% of the bill, this program is all but non-existent.There are other reasons as well this program is faulty.

Secondly a point regarding risk. When these innovatve therapies are snuffed it creates a domino effect of both increasing the expense to continue research as well as diminishing the interest of doing the research. Why risk hundreds of millions on a financially risky cancer therapy if you can make just as much by investigating a much better understood (by way of mechanism of action) and therefore less risky financially arthritis or cholesterol drug. The next Genentech will not be an American company because of the likes of Pazdur. Our pharmaceutical system is propped up by the enormous subsidies we provide the industry by way of higher drug prices here in the US and Medicare/private insurance. This is a house of cards and as the babyboomers age it will collapse. This combined with the inflexible nature of our current FDA towards cancer therapies will move the smaller innovative companies offshore or they will be sold off. In the meantime, people dying from cancer as we speak, are paying the price for our sins of omission. Shame on you MR. Pazdur, that isn't Medicine!

*********

Posted by unregistered user at 5/22/08 9:51 p.m. #131434

No matter how many different ways the story is told, it boils down to one thing.....FDA corruption----Pazdur et al.

Obvious corruption within the FDA is witnessed by thousands of Americans, yet the government does nothing. Top officials at the FDA--Eschenbach and Goodman--do nothing to right the wrong...they don't even see to it that the FDA complies with the Freedom of Information Act.

Of course Pazdur is talking about the Provenge Debacle.
What a sickening story. Will anyone in government blow the whistle? Where have the good guys gone?

*********

Posted by unregistered user at 5/23/08 12:59 a.m. #131455

Pazdur is clearly talking about Provenge and it's obvious he is trying to get ahead of the May 30 protests across the country. Unlike so many drugs that have gone before to a pre-mature grave, the prostate cancer victums and their families have choen to fight.

Between Dr. Pazdur and Dr. Sher, there are enough conflicts of interest with their involvement to choke a mule. If I were they I think I'd be very careful about involving myself in the future. Prison is not a friendly place.

But don't think they are alone in this travesty. Hedge funds, broker dealers, big chemo manufacturers and even the SEC have all conspired together in an attempt to either protect each other or to save billions of dollars at risk should Provenge be approved.

I have personally grieved over this matter and cannot believe our country is capable of letting travesties like this go this far. There are truly people involved who deserve to be locked up with the keys thrown away.

CALL YOUR STATE AND FEDERAL REPRESENTATIVES AND WRITE EVERY MEDIA OUTLET YOU CAN THINK OF. PUBLIC OUTCRY IS THE ONLY THING LEFT THAT WILL GET PROVENGE APPROVED AND EXPOSE THOSE RESPONSIBLE FOR TRYING TO KEEP IF FROM THOSE IN NEED !!!!

*********

Posted by unregistered user at 5/23/08 9:19 a.m. #131534

While I am a practicing Oncologist with an interest in cardiovascular health I neither see heart patients in a clinic nor do I prescribe statins, other than to an occasional family member. I own no stock in big pharma and loathe their almost omnipotent top to bottom ability to lobby and shape helathcare, often to the detriment of healthcare and taxpayers alike. Unfortunately that, or some variation, is what appears to be happening here despite the cute quips and phrases Dr. Pazdur injects.
For example, there is overwhelming evidence statins do save lives. Lipitor is one excellent example of a drug that has been shown to have positive effects above and beyond lowering cholesterol. Postulated to having anti-inflammatory effects on vascular endothelium, it lowers the risk of cardiovascular events(read lowered risk of heart attacks and strokes) in people with risk factors that cannot be accounted for simply via its cholesterol lowering capabilities. Lipitor is going off patent soon and will be able to save many lives for pennies a day. This makes it a target of big pharma and is partially at least the reason for the latest big pharma/FDA fiasco of the new, patented and high priced cholesterol lowering drug Vytorin(a combination drug containing Zocor/Zetia). Vytorin was and still is both ineffective and very costly compared to generic Zocor to the patients and taxpayers alike. How many cancer drugs were not developed because a drug company felt the safest way to profits was via developing an "easy to explain" drug to suit the FDA vs a poorly understood but revolutionary approach to Cancer like immunotherapy. How many people died because the only Rx their MD gave them was for a "Vytorin" they couldn't afford to fill. Unfortunately, this is not an isolated example. One can find similar if not more egregious examples in treatment of diabetes, hypertension, cancer and on and on.

Finally, I find it repugnant how Dr. Pazdur belittles some of the Advisory Committee members atitudes. These are world class Immunotherapists trying to reduce suffering and make the world a better place in doing so. What Immunotherapy qualifications do Dr.Pazdur and his cronies BEHIND closed doors possess? Likely NONE. This is a very sad era for Cancer patients when so much more could be done. By the way, I saw the Provenge studies as well as the report written by Dr. Pazdur's own biostatistician for the committee and I can see perfectly why the committee recommended approval.

[GuHu1]

nach dem interview mit pazdur herscht schlechte stimmung im IV, zweifel und unsicherheit kommen auf.
nun, es bleibt ein invest mit hohem risiko.
_____

http://www.pharmalot.com/2008/05/a-bill-for-experimental-med…

[edelupolino]

Antwort auf Beitrag Nr.: 34.164.859 von GuHu1 am 24.05.08 13:47:42

wem soll man glauben? was soll man von P halten, der einem patienten weitere chemo verweigerte -der wenige stunden später starb? Hatte P da richtig entschieden, da jemand, der sowieso stirbt, auch keine chemo (oder PROVENGE?) mehr braucht?

P scheint gut und böse in sich zu vereinen -je nach standpunkt:

Last fall, dozens of protestors gathered outside the FDA’s headquarters to complain about the agency’s handling of cancer medicines. Two prostate-cancer patients blamed the agency for rejecting the Dendreon vacccine known as Provenge, which they said helped keep them alive. Later, the group broke into a chant: “Pazdur Must Go! Pazdur Must Go!” On the other side, cancer researchers and other patient groups say Pazdur approves drugs that work and provides a bulwark against those that are unproven and potentially dangerous. http://www.pharmalot.com/2008/03/
friend-or-foe-the-fdas-controversial-cancer-doc/

Provenge muss also durch unzweifelhafte resultate überzeugen!...wobei ich hoffe, dass die dreisten shorts einen auf die mütze kriegen...

[edelupolino]

Antwort auf Beitrag Nr.: 34.167.057 von edelupolino am 25.05.08 12:47:35

eagleeyeinvestor hasst ihn; und die meisten von IV halten ihn für einen machtgeilen bürokraten (wie GOTT kann er über leben und tod entscheiden!)

Pazdur single handedly sabotaged Provenge's approval once before and IMO he is planning to do it again. This should be apparent to all after reading his Business week interview. We need massive protests against FDA and not just for Provenge. Pazdur must go one way or the other. This is just utter crap.

We are really fighting an uphill battle. No wonder the hedge funds are so confident in shorting DNDN. They have Pazdur in their pocket.

[GuHu1]

Antwort auf Beitrag Nr.: 34.167.468 von edelupolino am 25.05.08 15:31:40

eagleeyeinvestor hasst ihn.....

ich weiß, eagle war derjenige der, aus meiner sicht überraschend, zweifel äußerte.

[GuHu1]

http://blog.seattlepi.nwsource.com/thelifesciencesblog/archi…

[GuHu1]

http://www.bizmology.com/2008/05/23/the-risky-business-of-ca…

[edelupolino]

Author: cben


TOMORROW WILL GO DOWN IN HISTORY...
as the FIRST ever coast to coast FDA/prostate cancer protest. Here is your very private personal preview!!


The historical day will begin in the "Big Apple" at 8:30 am EDT in front of the workplace of Dr. Howard Scher, Memorial Sloan-Kettering Cancer Center - 1275 York Avenue. To finally take the fight to the door steps of another one of the main players....how fine is that?

At 11:00 am EDT, still reeling from the NY protest, we roll on down to the "Sunshine State" where we will make some noise at the FDA District Office - On the sidewalk in front of 555 Winderly Place.
...............

[GuHu1]

http://www.rttnews.com/ArticleView.aspx?Id=617660

[GuHu1]

Antwort auf Beitrag Nr.: 34.205.362 von GuHu1 am 30.05.08 15:35:59

MARINER FROM MSK CHECKS IN
Just got off the phone with Mariner who reports that a small group of our team met up this morning at Memorial Sloan Kettering, home of the infamous Howie Scher. No, no Howie as he is slated for ASCO today where Arnie Mass and Co. will be protesting today during our nation wide peaceful protests.

Mariner reports that Mike and Rory were there today for the kick-off. How much do I admire these folks.

Mariner will be reporting later but he wanted me to mention that he ran into the daughter of one of Howie's patients who was suffering with PC. Of course, Howie was more than eager to give the man a full prostate-ectomy. Ouch!
Mariner will be on later today to post the rest of the story. He's grabbing a quick cup of coffee and then heading back to MSK where he has staked out a hot spot right on the corner of the building.

Go Mariner! Go teams from coast to coast. And Thanks for doing this for all of those patients out there not wanting to face an excited Howie Scher with a sharp knife.

PS. Matt Herper from Forbes Magazine stopped by for a visit with out team out there. Way to go Provengers!

[GuHu1]

die geben alles, obs hilft, wer weiss, letztlich muss provenge überzeugen. from coast to coast respekt!

PHILLY UPDATE FROM MIKE K.
Well, our troops are on the street in Philly at the assembly area before their march on the FDA offices.
He said that they are passing out information sheets to a mostly enthusiastic and curious crowd.
Mike's on his bullhorn and we know how loud that can be...lol. We need more Mike's and Rory's with bullhorns.

Another interesting note. He said a man came up to him and pointed to a building across the street and mentioned that the FDA was in there right now meeting with a medical marketing company. I'll let you all draw your own conclusions about that. Probably Pazdur trying to hire a press agent.

Mike said they would be calling back in awhile as they start their march to the FDA office's.
We'll have to ask him if that office has one way glass as well.

GOOD GOING TO ALL PROVENGE AND CANCER SUPPORTERS.
BE WELL.

[GuHu1]

IV

http://www.nature.com/nrd/journal/v7/n6/full/nrd2610.html


In the media furore following the FDA's issuance of an approvable letter for Dendreon's prostate cancer vaccine Provenge (Sipuleucel-T) in May last year, attention focused on the need for more clinical efficacy data. However, another significant aspect for such therapies in general was largely overlooked. Although some additional data are required by the FDA for the chemistry, manufacturing and controls (CMC) section of the Biologics License Application (BLA) for Provenge, the manufacturer believes that it will readily be able to supply it. Successfully satisfying these requirements would represent a major achievement given the complexity of the product, which is an immunotherapy that is based on antigen-presenting cells (APCs) derived from the individual patient.

The CMC section of a BLA requires the sponsor to provide sufficient information to assure the proper identification, quality, purity and strength of a product, and can be influential in terms of the type of product a company is prepared to develop. One of the reasons Cell Genesys, US — which has a non-patient-specific cell-based immunotherapy, GVAX, in Phase III trials for prostate cancer — decided to stop pursuing autologous immunotherapies was because of the challenges that are associated with CMC-quality related characterization and controls, explains Carol Grundfest, Senior Vice President Regulatory Affairs at the company. "It is very difficult to characterize your product when you are faced with patient variability," she says.

In the case of Provenge, Dendreon also noted this challenge, but seems to have overcome it. "There is a lot of variability between patients and the actual number of APCs, for example, that they might produce, but the effects of the recombinant antigen on the loading and activation of the APCs in all patients is very consistent," says David Urdal, Chief Scientific Officer at Dendreon, USA.

[huetchen6]

30.05.2008 16:49
Merck KGaA: CHMP empfiehlt erweiterte Zulassung für Erbitux
DJ Merck KGaA: CHMP empfiehlt erweiterte Zulassung für Erbitux

FRANKFURT (Dow Jones)--Das wissenschaftliche Komitee der Europäischen Arzneimittelbehörde EMEA hat sich für eine Zulassungserweiterung des Krebsmedikaments "Erbitux" der Merck KGaA (News/Aktienkurs) ausgesprochen. Das Mittel sei nun auch zum Einsatz in der Erstlinentherapie bei metastasiertem Darmkrebs empfohlen worden, teilte der in Darmstadt beheimatete DAX-Konzern am Freitag mit.

Das Committee for Medicinal Products for Human Use (CHMP) habe zum einen den Einsatz des Medikaments als Erstlinientherapie in Kombination mit Chemotherapie empfohlen und zur Behandlung von Patienten als Monotherapie nach einer vorangegangenen erfolglosen Chemotherapie, hieß es.

DJG/hoa/jhe

(MORE TO FOLLOW) Dow Jones Newswires

May 30, 2008 09:48 ET (13:48 GMT)

Copyright (c) 2008 Dow Jones&Company, Inc.


der erste Schritt ist gemacht, trotzdem glaube ich der Mensch kann sich selbst heilen, ---- sein eigenes Immunsystem wie Provenge u. Stimuvax von Merck----Oncothyreon vormals Biomira.

[GuHu1]

Today in Seattle..

There was 15-20 demonstrators in all. . We were a force to be reckon with in our APPROVE PROVENGE NOW t-shirts, and awesome picket signs dancing in the air in sync with our chants. Ted G. lead the team in a circular march chanting "Hey hey FDA.." while Jason filmed away. A few of us took pictures. People approached us wanting to know more, and those already fed up with the FDA.
I noticed a young couple with their infant son watching from afar, I would say they had been watching for at least thirty minutes when I approached them. I gave them a flyer and brought up the reason we were there and then I suddenly noticed that the woman was angry, and the husband had the look of a patient undergoing chemo/radiation. The woman said: "I am a wife, and Mother look at my husband he is dying we understand all too well what the FDA does; thank you but we need to go." She walked away fast, he turned around and said "I am dying of brain cancer it is too late for me." I walked back to my team mates proud to be there, holding back tears.
I noticed a young man taking notes and realized it was Joe Tartakoff. I grabbed a t-shirt and gave him one. We had cops, strangers telling us their stories as it relates to Prostate Cancer. We received cash donations we raised awareness. One man did not know what Prostate cancer was, in fact he confessed that he did not know what a prostate was (there were several homeless people there). Jason our Seattle Coordinator was to the point and polite at the same time. The man said "I just don't know", and Jason explained that is why we are here. We are here to raise awareness, to educate..and of course to raise cain : = )
Ted, and Tedd Jr. were just great. Ted is a burst of light in a dark time. His attitude is inspiration for all of us.
Watch for Jason's post tonight, there will be pictures too!

Monica

[edelupolino]

...hoch gelobter salesman bei dndn verlässt die firma:

IV-leute sind sich nicht einig, was es bedeutet:

steveporsche: Re: Caggiano
It is troubling. Why would he want to leave now - leaving all those stock, options. and sales incentives on the table now after being with the company since Nov. 2004. The company issued PRs when he arrived and Gold praised him as a marketing wunderboy. Not a peep out of them now.

...wundert mich auch; er könnte bald die verkäufe seines lebens machen....und haut ab???

[NoSelters]

Antwort auf Beitrag Nr.: 34.229.549 von edelupolino am 03.06.08 19:13:51

Hmmmh...Vielleicht sollte man mal abwarten bis die Meldung offiziell ist,eventuell mit Nennung von Gründen.


No

[NoSelters]

Geiler Wunschtraum von ANMASS...

Caggiano
Leaves just prior to Annual meeting where announcenent will be made that a Big P will market Provenge World wide. Jim goes to work for that company to head up marketing for Immuno based therapies.Stock rises as we now have PA,hmmm?

[edelupolino]

Antwort auf Beitrag Nr.: 34.230.243 von NoSelters am 03.06.08 20:20:14

...das kann man wohl sagen; und weil wir nicht drin stecken (in den entscheidungsprozessen), müssen wir abwarten.

[GuHu1]

bin auch gespannt was dahintersteckt.

[edelupolino]

Obama wird wahrscheinlich POTUS, obwohl McCain viele befürworter hat.

...ich war daher nicht überrascht, meine geheimen wünsche in IV lesen zu können:

Beitrag 199476 (bitte an Warlord, weil er überzeugen kann!)
...I am sure Sen Obama will be interested in knowing how the COI's turpedoed Provenge's approval for a disease that disproportionately affects african americans.

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=200138&pt=…

DNDN, CEGE ASCO Updates, Follow-Up
First I would like to Thank all of you who sent me PMs with questions for DNDN. Thanks also to Marinar for faxing me the CareToLive flyer. I made 100 copies of the flyer and took them to the Session Hall where Howie was presenting. Since the session had started (it started at 11:30 am), I was not allowed to distribute the flyers by the Security. So I did what the speakers do; set the material on the table at the entrance of the hall with a "Please Take One" note. Marinar, there was no way I was going to say Hello to Howie. I try to keep away from criminals specially those that are guised as saviors. They get my blood boiling.

Now on to DNDN. I stopped again at the DNDN booth. The same gentleman was manning the booth. I asked him if he was the only one from DNDN at ASCO and he replied that there were 3 of them at ASCO. Since only one of 3 DNDN employees seem to work, it explains why they still have 200 employees.

I am going to post the responses to all the questions here for the benefit of everyone, as opposed to individual replies:

1. Does DNDN expect the interim trigger to happen in 2H08 or only that an announcement of the results will happen in 2H08?
It appears to me that the announcement of the results would be made in 2H08. I asked him if the events for the interim trigger had taken place. He did not say a definite NO, but said that he could not give me that info.

2. Related to that, how long does it take to analyze and announce the data after the trigger occurs?
He would not tell me that.

3. DNDN has said that the interim look is adequately powered. Is the interim power anywhere close to the 88% for the final? Is it at least 50%?
I asked him regarding the alpha spent. He said that information had not been made public (As I said, he has been trained by Mitch)

4. When can we expect final data from P-11? Isn't any kind of update possible?
According to him, although the P-11 is fully recruited, the results are not expected for "many years" as it involved patients that had ADPC who are generally healthier.

5. I would ask or try to find info if interim data hits stat sig but misses alpha, will they try to file? I wonder if FDA will look at interim data regardless if it hits alpha or not?
He said that if the interim missed alpha, the DMC would not inform them and the trial would continue.

6. How is "positive data" defined for this purpose as used in the FDA agreement with Dendreon?
Hitting the alpha

7. Clarify issue regarding Frovenge
He said that there weren't any significant issues with Frovenge other than it was not as effective as Provenge

8. Considering the corrupt state of affairs at the FDA, where is Dendeon at with regards to making application for drug approval in europe?
He said that they would look at European Approval only after US Approval.

Later that evening, I met a former DNDN Sales employee. He said that DNDN had eliminated the entire sales force and Jim Caggiano was "let go". He also said that Mitch Gold's aim is to make money and he would do whatever would be good to maintain his wealth (I hope the pps as well).

I also stopped by the CEGE booth and did mention to the person at the booth, that there were other prostate cancer vaccines that were likely to be approved before their Vital 2 trial was fully recruited. She shrugged her shoulders and said that she was aware of that.

I guess that is all the update from ASCO. I have to mention that Jeff Schlom in his presentation showed the survival curves from the Provenge trials a number of times. He also emphasised that immunotherapies should be given before chemotherapy and not the other way.

Regards to all,
Jeep
_______________________

http://www.investorvillage.com/smbd.asp?mb=971&mn=200114&pt=…

DNDN ASM notes from tetrimbath
Pardon the delay, but it takes a while to get back to my computer on the island. Sorry if I duplicated efforts.

The quickest synopsis for long term shareholders was that the only real news to me were the new trials: P07-1, P07-2, and something else with Trp-P8. Everything else was old data and familiar explanations.

CAVEAT
I am human, not a biotech professional, not an finance professional, and can't take notes as quickly as they speak. Mistakes will be made. When you really have to know, ask me for clarification, other attendees for other points of view, and get the official words from the company, the FDA, and the SEC.

PRE-MEETING
I woke up early because I wanted to make sure I got a seat. Each year the company's small conference theater fills more quickly and I didn't want to have to sit in some annex watching a web cast. Past performance is no predictor of future results, which means that this year at ten minutes before the meeting there were only three investors in a room that holds about 150. That seemed like a serious lack of interest. No wonder the price stays low.

By the time the meeting started about 60 people roamed in from the free organic coffee, juice, bagel, fruit, and pastry buffet. Pity. I really would've liked bacon and eggs.

FORMAL MEETING
Everything passed, as always. I was surprised to hear that only 78% of the shares were represented. Last year it was closer to 88%. Ten percent of the shares decided it wasn't worth attending. Again, an indication of lower interest, and possibly demand, for the stock.

BUSINESS PRESENTATION
The COB talked about how the company can have tremendous impact and that they will be as successful as they can be.


The CEO presented the majority of the business overview.

The three main bullet points that I picked up were that the company was well financed, putting patients first, and is a successful organization. (If anyone has lots of free time, check how many times he called Dendreon an organization instead of a company or a business.)

The pipeline is primarily actice cellular immunotherapies. There are few existing alternatives. In addition he also mentioned the small molecule work. The list presented was Provenge, Neuvenge, CGA, CP9, Trp-P8. The pipeline addresses many prominent cancers: prostate, breast, ovarian, colon, bladder, lung, cervical, and renal. The clinical trial response so far suggests that Dendreon's technology enables a durable immune response for front line treatments, with minimal side effects.

He reviewed Provenge clinical trials 9901, 9901+9902A with an emphasis on the survival data. In particular he mentioned the three year survival of 34% for Provenge versus 11% for placebo. Unsurprisingly, he kept to the 2H08 schedule for the IMPACT results; and pointed out that if IMPACT is similar to 9901+9902A, then they'll probably meet their endpoint.

From what he said I get the impression that they will market the convenience of the treatment as well as the efficacy and the results. It only takes one blood donation and three re-injections. That is less than is required from chemotherapy.

Later this year the P07-1 trial will begin investigating other aspects (booster shots?), and P07-2 will investigate dosage.


Dr. Urdal (sp?) took over to give more details about the Trp-P8 work. Evidently it works by allowing calcium to flow into the cells and letting them die. It can also be used for treating benign prostate hyperplasia, and no, I don't know what that is. They plan to file and IND for human trials this year.


The CFO quickly pointed out that the company is in a comfortable enough financial condition to see it through to Provenge. They should be first to market. Then they can expand into earlier and later stage treatments, and proving the cassette technology will he an important benefit to the pipeline.

QUESTIONS & ANSWERS (paraphrased because otherwise I can't keep up)
> Go to the web site for details on how to apply for the clinical trial.
> The FDA is data driven so the schedule for approving Provenge is limited by that process.
> The company chose the number of death events. (Something about 88% and 305 deaths)
> The company will relay the news about the interim in a timely fashion.
> The side effects of Dendreon's treatments are like getting the flu for three days.
> The time from receiving news about the interim to a possible FDA decision is measured in months, probably less than six because of the SPA.
> They won't discuss the shareholder lawsuit.
> The P07-1/2 trials are at Dendreon's initiative. The trials will also reveal whether the treatment is tissue specific. (my note: If it isn't tissue specific can it be used for other cancers without requiring separate approval?) The trials will also provide some access to patients from 9902B (but sounds odd to me, so check with the company).
> Sales & Marketing can be ramped up readily. New Jersey is ready to go to work.
> The company will relay the news about the interim in a timely fashion.
> Partnerships for outside-US will be discussed more energetically after the receipt of the data (inter?, final?).
> Dendreon received a European patent, not a European approval.
> A competitor (cougar compound? abardonin? what???) would probably be used after not before Provenge.
> P07-1/2 and circulating tumor cells will be explored later. (?)
> The CEO is the wrong guy to ask about why the FDA doesn't seem to appreciate the benefit/risk situation between Provenge and people dying while the clinical trials grind through the process.
> The 4.5 month increase in life seems small because it is a median. The three year survival (34% vs 11%) is more telling.
> The supply issue with frozen, stored Provenge is with a chemical used in the freezing process, not with Provenge itself.

SUMMARY & CONCLUSION
Like I said at the start, in large part, there is nothing new. The P07-1/2 and the IND for Trp-P8 are activity, but they are not Neuvenge and pale beside the status of Provenge, the IMPACT trial, the interim analysis and the final analysis. As shareholders, we still have to wait (pardon me as I refresh the headlines, nope not yet) a few months and then a few months. As one shareholder pointed out, the cynical view will be that the price will pop before the news comes out, so checking the headlines is not necessary. For prostate cancer patients the wait is longer. After approval, it will still take some time to fully educate the physicians. For other cancer patients, the wait is probably years.

As I read the annual report I finally wrote down all of the cancers that are targeted by Dendreon: prostate, breast, ovarian, colon, bladder, lung, cervical, renal. Even if the company's treatments don't successfully treat 100% of each of those cancers, the company has the potential to be treating a majority of the cancer patients. That is a large market. The other thing that struck me was that the company seems to treat such possibilities as abstract. Such an enormous impact should be the subject of major news items, a key element in corporate communications, the lever for moving the debate and the trials into a more even playing field. And yet, several times they talked about getting Provenge over the line, as if the subsequent potential would detract or hinder the energy behind approval.

I am convinced that the technology is valid and necessary, and fortunately can be the basis for a profitable and sustainable company. I believe the management is intelligent. I have to also admit that I think the management is too narrowly focused and, despite what their compensation package suggests, may not be fully aware of the company's resources. Putting patients first is a wonderful motto, and maybe it requires looking beyond the conventional relationship with governmental regulatory agencies. (Whew, had a soap box moment there.)

FINAL WORDS
Dendreon remains a speculative investment that can rapidly become a financial success or slowly grind along. Everything relies on the IMPACT analysis, be it this year or next. If the FDA approves, then the company swings to one extreme. If the FDA doesn't approve, it might take a lot longer to recover, if ever.

DISCLAIMER
LTBH since 2002 and optimistic based on data but pessimistic based on politics.

[hakur]

Habe eben diese Nachricht erhalten, gebe diese in Auszügen wieder.
Care to live bekommt so wie es aussieht Prozesskostenerstattung!

hierzu diese Info:

Did you see post 200222 - Kerry Donahue's appeal.

As I mentioned, the government lawyers engage in word games. So KDD has caught them - The man who sent the approvable letter was not authorized to approve or dis-approve.

So hundreds of millions of dollars, and the FDA never formally reviewed the application. This is just disgraceful.


Again, I don't think this will significantly affect the price of the stock directly, but the persons named in the suit (govenment employees) will tire of the danger.

They can easily get out of the lawsuit mess by approving Provenge.

Denke dass da die andere Seite ( Shorts)doch etwas kalte Füße bekommen wird. Charttechnisch sind wir wieder einmal bei einer Aulösung eines kleinen fallenden Keiles nach Norden! Bin es fast leid dies hier zu schreiben.
Was jedoch ermutigend ist dass ein großer fallender Keil in der Mache ist. Versuche diesen demnächst reinzustellen.
So looong

[GuHu1]

hakur, stells nach bestem wissen rein und lass dich nicht entmutigen.

[edelupolino]

Antwort auf Beitrag Nr.: 34.249.694 von hakur am 05.06.08 22:11:48

...freu mich schon auf den keil;

die spannung steigt, und im IV-thread werden die interessantesten ideen verbreitet -auch durch den weggang des verkäufers.

[GuHu1]

hi ede,
das sind aber mit unter wilde spekulationen und die werden zunehmen, je weiter wir im 2 halbjahr voranschreiten.

[edelupolino]

Antwort auf Beitrag Nr.: 34.250.264 von GuHu1 am 05.06.08 23:23:13

Es ist wahr, dass einige wie hasardeure denken und ALLES auf Dndn setzen; einer hat im moment 100.000 aktien und gibt zu, dass sein vermögen i.m. nur aus diesen aktien besteht. Wenn Dndn die zulassung erhält, gewinnt er alles (bei träumen von 100$ die aktie), wenn Dndn verliert, "leckt er nur seine wunden", behauptet er..-harter typ! Meiner meinung nach aber zu unvorsichtig.
... interessant ist auf jeden fall die speku, dass Gold sich doch mit Big Ph zusammentun will (einige schließen das aus dem weggang von C.)...es bleibt spannend!

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=200400&pt=…

The Only One Who Won't Know Is Dendreon/green&BULL
<Green:
Are either of these scenarios standard FDA practice? In the second scenario, you have the FDA opting for approval even though the OS alpha was not met.>

The DSMB operates independently from either DNDN or the FDA. They are a group of clinicians and statisticians who overlook the trial progress while preserving blind. So, the answer to your question is no. Neither scenario would be standard FDA practice. But, there are plenty of prior examples of DSMB proposing to stop a trial when data go extreme, either well or badly. If the DSMB make such a suggestion, it would then be up to the company and the FDA to decide together whether or not to follow their suggestion and then how to proceed afterward.

<BULL: You want to see the conflicted chemotherapists change religions just watch if your second scenario unfolds. The fascist biostaticians like Fleming will come out of the woodwork and Padzur will be as smug as ever. >

The reaction above is irrationally reflexive. If the company and the FDA together decide to follow the DSMB suggestion to stop the trial because of sufficiently good data, then the process should progress positively for Provenge.

[GuHu1]

http://npg.nature.com/nbt/journal/v26/n5/full/nbt0508-484b.h…

[GuHu1]

statement eines der langjährigen unterstützer von provenge / dndn.

Rancherho speculative quote proprovenge:

I still think that the science is good. I definitely agreed with the post of speedrunner just before the Advisory Committee that the Petrylak analysis of Provenge + Taxotere, which was never presented to or discussed with the Advisory Committee, should have, and even if indirectly, did support the AC's recommendation for approval conditional on continuing and ultimate success of 9902b. I still believe (hope) that the FDA will approve Provenge. To a certain extent, 9902b, with a greater number of events than all of 9901 and 9902b is essentially a doubling down on any risk of success to date, so there is a continuing risk. It's speculative in that if either Provenge or GVAX fail, it is almost catastrophic for DNDN or CEGE.

I admit that the failure of Gold and Urdal to warn investors that a Form 483 listing several significant objectionable conditions as a result of DNDN's February 2007 preapproval inspection soured me on DNDN. I had lost some when I read BSR's positive nalaysis and invested in DSCO, but sold when DSCO itself warned of the Form 483 issued to their then outsourced manufacturer prior to their PDUFA date. If Urdal or Gold had disclosed the issuance of a Form 483 during the conference call on March 29th after the AC when asked by Charles Duncan, instead of the misleading "We had a good inspection", I would not have purchased more and as a result taken substantial losses. As of March 08 CC, Gold acknowledged that the Form 483 observations had still not been cleared up. As for Urdal's comments in May and August that the FDA could have approved Provenge in spite of not having cleared the Form 483 issues, he should know, and undoubtedly does, that Federal law and FDA regulations prohhibit any such action.

In any event, for the sake of suffering cancer patients, I hope that both Provenge and GVAX are quickly approved. JMHO.

[edelupolino]

Antwort auf Beitrag Nr.: 34.260.332 von GuHu1 am 07.06.08 12:58:42

Hi GuHu,
wenn die Form483-probleme/auffälligkeiten noch nicht beseitigt sind, werde ich erst mal nicht nachkaufen.
Ciao Ede

[GuHu1]

Antwort auf Beitrag Nr.: 34.260.750 von edelupolino am 07.06.08 15:00:58

hi ede,
klar das ist schließlich derzeit ein 50:50 invest. vorsicht ist die mutter der......

ich warte die interims daten ab, das was ich im spiel habe reicht.

[sauerback]

Dendreon files $300 mln mixed shelf offering
Wed Jun 11, 2008 6:24am EDT

June 11 (Reuters) - Dendreon Corp (DNDN.O: Quote, Profile, Research) said it may periodically sell up to $300 million in debt securities, common and preferred stock, and warrants.

The company intends to use the proceeds mainly to fund marketing of its prostate cancer product candidate Provenge, it said in a regulatory filing.

Under a shelf registration filed with the U.S. Securities and Exchange Commission, a company may sell securities in one or more separate offerings with the size, price and terms to be determined at the time of sale. (Reporting by Bhaswati Mukhopadhyay in Bangalore; Editing by Gopakumar Warrier)

[LaPlue]

wann kommen die interimsdaten???

[edelupolino]

Antwort auf Beitrag Nr.: 34.288.788 von LaPlue am 12.06.08 12:38:35

...6. The best question to ask is what will make Dendreon shares of common go a rocket? The FDA approval of Provenge is the simple answer. Such a decision will be on the desk of the FDA by December of 2009 in the worse case. Some here strongly believe that the interim look will be successful. The interim look by the FDA is where the data results from the current trial have matured enough and demonstrate a favorable survival characteristic that is due to Provenge. This could occur in the second half of 2008-- as soon as September...it will take awhile to compile the data. The uberoptimistics think that after July 1, anything is game on.

Author: fordwill1953
message 201054 of 201091 6/11/2008

[GuHu1]

http://blog.seattlepi.nwsource.com/thelifesciencesblog/archi…

[NoSelters]

...und noch ein Basher-Blättchen...

http://www.schaeffersresearch.com/commentary/content/option+…

[edelupolino]

klasse bericht über Provenge und heilung! (aus IV, 6/13/08)

http://www.news8austin.com/shared/video/video_pop.asp?destli…

[edelupolino]

Antwort auf Beitrag Nr.: 34.296.939 von edelupolino am 13.06.08 13:26:24

sehe gerade, dass diese news aus 2007 sein soll (schade),so meint "henrylucas" -etwas später im thread.

[GuHu1]

ocyan, IV:

http://www.investorvillage.com/smbd.asp?mb=971&mn=201385&pt=…

Recs: 47 Re: Shelf Registration/ TFRingo, FYI: Close Doesn't Count
<caseytarman: A stat sig Interim or Final puts us at the opponent's 18-yard line with a first and ten...
So, First and 18 ain't no great shakes, as Drs. Scher, Hussain, vonEschenbach, Pazdur et al made clear in April and May a year ago when we used up four downs without gaining a yard.>

This is an irrationally negative opinion of the prospect of Provenge approval for a long investor.

Let me first say that stat sig at either the interim or the final will put us at the goal line. There will be some remaining work to do to update the BLA and get the plant in NJ pass re-inspection but the company will be responsible for that and nobody else.

Next, let's discuss what happened last May. There are individuals with questionable motive everywhere, including the FDA and other venues such as here. Such people can impede progress by raising doubt but they too must act with some air of proper appearance in following regulations and customs.

With that in mind, anyone rationally dissecting what happened last May would see that, even though the FDA made a mistake in not following the conclusion of their own Advisory Committee, there were enough issues with the data presented in the BLA for them to rationalize their decision. So, what were those issues?

The BLA was based on a survival stat sig result from D9901. First, survival was not specified as an endpoint in D9901. As such, its finding could be seen from a statistical perspective as accidental. However, because survival was implicitly an endpoint for any trial testing a drug in a terminal disease, it must be taken seriously. Accepting that, the next issue was the small trial size which meant that the likelihood of certain imbalances in key prognostic factors skewing the results was real.

For biological data, imbalances could be from well-known prognostic factors or from ones that nobody has even thought of yet. This is a main reason to run randomized trials in testing drugs. The randomization principle guarantees that if the sample or number of patients was large enough, even unknown prognostic factors (as long as not too many) would be probabilistically balanced.

If D9901 was pristine, its use for the approval process might have worked. However, there were imbalances such as Gleason Score or bone+soft tissue favoring the treatment arm. Even though various sensitivity analysis both by the company and the FDA found that such imbalances did not affect the significant survival result, their existence coupling with the small trial size meant that there was a need for confirming the data via some other source such as another trial or general scientific knowledge of the disease, etc.

Unfortunately, the other trial, D9902a, was even smaller than D9901 and suffered a much worse imbalance in the number of bone lesions keeping it far from being stat sig with a p value of 0.32. The Cox analysis that supposedly restore significance to D9902a was casted in doubt due to missing data. Last but not least, even though D9902a was run with identical protocol to D9901, the enrolled patients seemed much sicker than D9901. That raised the question of whether or not the trial was well-run or if the protocol was not sufficient tight to guarantee a uniform patient selection process.

Putting all that together says that what remained in supporting the stat sig survival result of D9901 was only the discussion of the Advisory Committee and their votes. The consideration of the data was taken from an objective data-oriented process into an opinion-based process. The latter opened ground for possible dissension within the FDA on approval and allowed individuals with impure motives such as Howard Scher and others to assert their view. So, even though the final decision of the FDA to not even granting Provenge conditional approval was an unmitigated mistake, it did have some air of legitimacy.

Now, back to IMPACT. This is a trial with more than 500 enrolled patients, large enough to alleviate any fear of imbalances due to unknown factors. Further, the trial employed stratification of key prognostic factors such as Gleason Score and Bone Lesion Count to ensure their balance. Even the new condition of allowing minimal pain but clarifying its meaning as no non-opioid drugs (thanks p3) served to tighten the protocol and ensure better uniform enrollment. The evaluation of pain was now an objective process instead of relying on personal patient assessment. The latter might have caused D9902a to inadvertently enroll much sicker patients who had large number of bone lesions, yet somehow no bone pain!

So what we have in IMPACT is a trial that is sufficiently large and has been improved in design from D9901 and D9902a to ensure uniform enrollment and to minimize imbalances. Further, unlike other trials such as the ones done by ENCY and others with imprecisely defined endpoints, survival is clear cut - the patient is either alive or dead! As such, the results of IMPACT will be definitive in showing whether or not Provenge works as a drug. Even the naysayers such as Scher and Hussain said so at the AC meeting.

In turn, that means that the data from IMPACT will again be evaluated in an objective data-oriented process and not an opinion-based one. There is little reason to continue with any irrational doubt about the approval process. In fact, anyone believing that Provenge works and investing in its eventual approval should be optimistic with the design of IMPACT and its chance of achieving stat sig either at the interim or the final look.

[GuHu1]

Form 8K June 15
DENDREON CORP Files SEC form 8-K, Other Events
6/16/2008 1:47:00 PM (EDGAR Online)

16-Jun-2008

Other Events

Item 8.01 Other Events.

On June 15, 2008, Gerardo Canet, a member of the Board of Directors of Dendreon Corporation (the "Company" adopted a pre-arranged trading plan (the "Plan" designed to comply with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, and the Company's policies regarding insider stock trading transactions. Under 10b5-1, directors, officers and other persons who are not in possession of material non-public information may adopt a pre-arranged plan or contract for the sale of Company securities under specified conditions and at specified times. As sales are executed in the future under the Plan, they will be reported in accordance with federal securities laws.

The Plan provides for the sale of up to a total of 109,171 shares currently beneficially held by Mr. Canet pursuant to presently exercisable stock options over a period beginning June 15, 2008 and ending December 15, 2008. Shares will be sold under the Plan on the open market at prevailing market prices, subject to minimum price thresholds and other sale date requirements.

The Company does not undertake to report Rule 10b5-1 plans that may be adopted by any officers or directors of the Company in the future, or to report any modifications or termination of any publicly announced plan or to report any plan adopted by an employee who is not an executive officer, except to the extent required by law.

http://www.investorvillage.com/smbd.asp?mb=971&mn=201519&pt=…

[GuHu1]

http://www.opednews.com/articles/1/genera_evelyn_p_080108_bu…

[edelupolino]

Antwort auf Beitrag Nr.: 34.320.589 von GuHu1 am 17.06.08 23:18:23

Hi GuHu,
wieder ein bezeichnender artikel!

Aber ich glaube, dass selbst unter "Heiligen" wie Carter oder Kennedy im finanzbereich getrickst und betrogen wurde, was das zeug hält. Der Mensch an sich ist offensichtlich so gebaut, dass "anything goes".
Es bereitet aber schon verdruss, wenn man nichts von seinem gutsein hat (und besser ist als Bush...); wir sind oft die lackierten , denn die " losers are always the investors who play by the rules and make bets based on the best public information available." (vgl artikel)

Von daher find ichs schön, dass der Dndn-director seine finanzaktionen offen legt.
Wir können danach handeln!
Ciao Ede

[edelupolino]

Antwort auf Beitrag Nr.: 34.320.589 von GuHu1 am 17.06.08 23:18:23

...Pazdur natürlich auch wieder dabei...

[GuHu1]

Antwort auf Beitrag Nr.: 34.323.753 von edelupolino am 18.06.08 13:07:15

hi ede,
stimme dir zu, nach meiner meinung ist das in usa seit je her gang und gebe.
jetzt sind halt investoren der kleinen bio schmiede dndn betroffen.

zum aktuellen thema "Gerardo Canet" finde ich die postings vom user ocyan recht treffend wie z.b.:

http://www.investorvillage.com/smbd.asp?mb=971&mn=201771&pt=…

aber auch zu den chancen von provnege hat er / sie aus meiner sicht gute argumente pro dndn.

[Poppholz]

warten, warten, warten

[NoSelters]

FRAGE

Wo sehen die Charttechniker unter uns einen "festen" Widerstand nach unten?
Hakur schrieb was von einem grossen,fallenden Keil....wo müsste der nach oben ausbrechen? Wie gesagt,ganz unverbindlich und nur unter Berücksichtigung des Charts.


Hakur...?

Gruß No

[GuHu1]

nun morgen beginnt das 2 halbjahr und pünktlich dazu das folgende.

http://www.investorvillage.com/smbd.asp?mb=971&mn=203276&pt=…

Dynamical Biotech Prognostications offers first official prediction...

Many of you know me as the one who tipped the board off, in an un-official capacity, to the screaming buy which SUPG presented around $5.00; I now am stepping into the void and herewith offer my first official prognostical prediction...

DNDN share price will skyrocket ot over $10.00 as rumor...also known in WS parlance as "chatter", begins to circulate indicating that DNDN is in serious ROW talks with BP suitor or being considered for outright acquisition sometime before mid-August 2008.

I offer this as a freebie to go on record establishing my bona fides as a legitimate member of the WS analyst club.



*Disclaimer...this is not to be construed as advice to purchase the Aug. or Jan. $5.00 calls nor as encouragement to take any position in DNDN's stock.

[GuHu1]

IV, yarbonero

http://www.investorvillage.com/smbd.asp?mb=971&mn=203306&pt=…

Our Sadly Neglected Petition

A brief outline of some of the conversation.

I spoke with Paul Richards at the FDA for over an hour the other day concerning our petition. He is the Public Relations Specialist for CBER. He told me from the start that I would not be happy with the answers. His job is to disclose nothing, to cover their a$$e$. He said he attended our Advisory Committee meeting but from the conversation he said that the original question is the congressionally mandated question, does the product establish efficacy and he thinks that the question was switched by Dr. Goodman, because people were having trouble answering it, to smooth things over, because Provenge did not establish efficacy. He thinks they tried to help the panelists and Dendreon and give them an unfair advantage, by switching the question from the bastardized question. I said they should investigate who switched it and that the question is suposed to be the congressionally mandated standard “sutstantial evidence of efficacy”. I said that 3 of the nay sayers refused to answer that question. Maha said substantial and establish are the same thing, scher said yes to one and no to the other, so no to both, and chappell said no to establish, the original question and never answer the corrected question. He ignored me, and said that the science wasn’t there and they needed more data and I should check with Dendreon. I told him that Congress mandated that drugs needed to be sped up to market in cases where there are unmet needs and the advisory panel was to help advise them. He said that is true that there is a mandate. I said Provenge fit into that mandate, and he said there are other options. I said there are not, since the only approved treatment is 43 years is so toxic, most men refuse it. He said the agency is science based and I said that was nonsense because the science was there nad they voted it 17-0 and 13-4, not 4 to 13. said they could have given it a conditional approval, and he agreed. I told him they no longer use ttp for immunotherapies and that Russia and Cuba have both approved immunotherapies. I said that the FDA admitted it does not have the money to keep up with the science. He said he is not a scientist.

83 men dying every day with no options is apparently not a priority at the FDA. Our petition and comments are not a priority and their number one priorities is approving drugs and doing inspections. If they saw your comments, and that is a big if, they are not important to them. I asked if they checked into the Conflicts of Interest that were undisclosed and I was first told they didn’t and then I was told that they were satisfied, and then I was told that they couldn’t disclose anything about the waivers and our petition. They have too many petitions and too many comments and they do not have the staff to address them. I asked how often they meet to discuss our petiton and was told they may not even have meetings. I asked if they do it by email or memos but they could not disclose this. The said the decision is science based and that I should check wiht Dendreon about the science and the data. He said if I want to know what is going on with the approval. He told me the fda is a compassionate agency which I laughed at. He told me he empathized with me several times. He said the FDA is the best regulatory agency for drugs in the world which I said that is nonsense, and that we have lost our edge. He said they only approve about 10% of drugs that come through and I said that was not my concern, my concern was with Provenge.

It is clear that they are doing nothing with our petition. 11 months for men who are desperate and to get no answer but to check with Dendreon, shows the whole petition process is a sham. They are not a compassionate agency whatsoever. I was just told by the person processing our comments that they usually send a letter 180 days after a petition is submitted to say that comments are closed. I never received any letter so our comments must still be open. I just scanned the site for open or closed but nothing came up. I asked them a while ago how long we could comment for but never received an answer. You can leave comments here, and also send hard copies to dockets and tell them to post them, otherwise they may be keeping them private, they didn’t seem to know what is going on at the new site..
Please resubmit your comments for the record. You may also submit new ones. Paul Richards sayid it does not slow down the petition process.

Our Petition number is 2007P-0297 on regulations.gov although they assigned another number to us in the migration...duh Docket ID: FDA-2007-P-0168

2007P-0297 Request to reconsider the failure to approve Provenge FDA Comment Number... …

Agency: FDA Document Type: PUBLIC SUBMISSIONS Comments Due:
Docket ID: FDA-2007-P-0168 Document ID: FDA-2007-P-0168-0010


You can find it here

http://www.regulations.gov/search/search_results.jsp?css=0&N…
8053+8054+8098+8074+8066+8084+8055&Ntt=2007P-0297&sid=11ADB072C40D" target="_blank" rel="nofollow ugc noopener">http://www.regulations.gov/search/search_results.jsp?css=0&N…
8053+8054+8098+8074+8066+8084+8055&Ntt=2007P-0297&sid=11ADB072C40D

The regulation for petitons is CFR 10.30(e)(2)

If you don’t see your comments there, I suggest you resubmit them, since they migrated the comments section to this new site and many did not make it. It looks like those who wrote them right on the new site, are there, and the others are not. You may also want to send a hard copy to dockets mail or fax, and ask them to post them. We are still waiting for them to post Dr. Goodmans 6 month reconsideration letter saying they are not done reconsidering, on the site.

http://www.fda.gov/ohrms/dockets/

Submit any comments to our Citizens’ Petition at the FDA plus attachments that might help our cause.
You may fax, email and/or snail mail them.
Please include:
Docket number 2007P-0297
Request to Reconsider the Failure to Approve Provenge
Fax [phone]
email [e-mail]
Mail:
Lyle D. Jaffe
Division of Dockets Management
Food and Drug Administration, 5630 Fishers Lane
Room 1061 (HFA-305)
Rockville, MD, 20852
If you have any trouble you may call Lyle Jaffe at 301-827-6869.

[hakur]

Antwort auf Beitrag Nr.: 34.356.267 von NoSelters am 23.06.08 18:51:49

Sorry hatte etwas wenig Zeit, gab außerdem auch keinen Grund diese Charts schon früher reinzu stellen.
Der große Keil war und ist noch nicht fertig gefüllt. Hatte ja angedeutet dass da einer in der Mache ist.
Ein Hinweis , es sind Wochen-Charts.
Also ein Candle = eine Woche. Man kann sehen dass in den Keil gut noch eine zusätzliche Woche passen würde. Muß aber nicht der Fall sein!
Am Langfrist Chart kann man gut die auflösung der großen Keile sehen. Was mit dem jetzigen geschieht , let as see sage ich nur. Für mich persönlich habe ich die vage Hoffnung dass der Kurs sich endlich in die richtige Richtung bewegt;-))
An den kleinen fallenden Keilen im letzten Jahr kann man gut sehen dass es immer nur zu einer kurzfristigen Erholung kam. Mit den anstehenden Interims-daten sollte dies jetzt den Trend nach Norden unterstützen.

So loong

Ps. Bin jetzt 4 Wochen nicht hier.

[sauerback]

Ist da etwas im Busch? Schon über +10%

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 34.465.343 von sauerback am 08.07.08 21:50:56

Ich glaube, daß war nur eine technische Gegenreaktion auf die heftigen Verluste der letzten Zeit!
Würde mich freuen wenns auf News basiert!

[GuHu1]

Antwort auf Beitrag Nr.: 34.465.861 von Magnetfeldfredy am 08.07.08 22:51:04

ich denke da steckt keine news hinter.
hatten wir das nicht vor 2 monaten auch um die $ 4,30.

[bernie55]

FDA News

July 9, 2008

FDA Revises Process for Responding to Drug Applications

The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.

"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."

Taking the place of "approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.

Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an "approvable" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a "not approvable" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.

"Complete response" letters are already used to respond to companies that submit biologic license applications. The process for drugs and biologics will be consistent under the new regulations.

The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications. These changes, which will become effective on Aug. 11, 2008, are not expected to directly affect consumers.

In July 2004, the FDA issued a proposed rule on these topics. At that time the agency asked for comments on the proposal. Today's final rule addresses comments submitted to the agency.

For more information, see:

Link to the Complete Response Final Rule
http://www.fda.gov/cder/regulatory/complete_response_FR/defa…

Link to the drug approval process page
http://www.fda.gov/fdac/special/testtubetopatient/default.ht…



http://www.fda.gov/bbs/topics/NEWS/2008/NEW01859.html

[edelupolino]

Antwort auf Beitrag Nr.: 34.478.676 von bernie55 am 10.07.08 12:24:30

alles schön und schlecht:

die sollten mal lieber das hauptproblem bei der FDA lösen -alle, die mit coi zu tun haben oder hatten, dürfen in keiner weise bei gesprächen über neue drugs und schon gar nicht bei abstimmungen beteiligt werden.

Alles andere ist augenwischerei wenn nicht sogar bewusste lüge und irreführung.

[GuHu1]

Antwort auf Beitrag Nr.: 34.480.972 von edelupolino am 10.07.08 16:03:39

http://www.pharmalot.com/2008/07/big-very-big-fda-bonuses-re…

[GuHu1]

The Promise Of Cancer Vaccines Along With Hormone Therapy

[GuHu1]

http://www.marketwatch.com/News/Story/Story.aspx?guid=%7B2E4…

SEC to limit naked shorting of Fannie, Freddie, brokers
By Alistair Barr
Last update: 1:29 p.m. EDT July 15, 2008
Comments: 72
SAN FRANCISCO (MarketWatch) -- Christopher Cox, chairman of the Securities and Exchange Commission, said on Tuesday that the regulator will try to limit so-called naked shorting of shares in Fannie Mae, Freddie Mac, and primary dealers including Lehman Brothers, Merrill Lynch, Morgan Stanley and Goldman Sachs. The SEC will issue an emergency order stating that all short sales of shares in these companies will be subject to a "pre-borrow" requirement, Cox explained. This will last for 30 days, he added. The SEC is also planning more rule-making focused on the broader market, Cox said. In a typical short sale, traders sell borrowed shares, hoping to buy them back at a lower price and return them to the lender. The difference is kept as profit. In naked shorting, a trader shorts a stock without first making necessary arrangements to borrow shares. That sometimes means the seller fails to deliver the stock to the buyer and the trade can't be settled, running afoul of securities laws. End of Story

[sauerback]

Dendreon Initiates Phase 2 Trial of PROVENGE in Patients With Localized Prostate Cancer Prior to Surgery
Wednesday July 16, 7:30 am ET

SEATTLE, July 16 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that the Company has initiated a Phase 2 trial of PROVENGE® (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for the treatment of prostate cancer, in men with localized prostate cancer who are scheduled to undergo a radical prostatectomy. The single-center trial called NeoACT (NEOadjuvant Active Cellular immunoTherapy), or P07-1, which is being conducted at UCSF Helen Diller Family Comprehensive Cancer Center, has begun enrolling approximately 40 patients. NeoACT is the first of two new Phase 2 trials of PROVENGE being initiated this year.


Each patient will receive a complete course of active treatment over a one-month period beginning six to seven weeks prior to the patient's radical prostatectomy. The course of treatment will consist of three infusions of PROVENGE-two weeks apart. Multiple safety and efficacy endpoints will be evaluated including the immune response in the prostatectomy specimens and in the peripheral blood. Following radical prostatectomy, patients will be randomized to receive either a booster of PROVENGE or no booster. Patients interested in additional information about this trial may visit http://www.clinicaltrials.gov and use the search term "NeoACT."

"I am pleased to help lead the NeoACT clinical trial, given the therapeutic potential of immunotherapy for prostate cancer," stated Lawrence Fong, M.D., principal investigator of the NeoACT trial and associate professor of medicine at UCSF Helen Diller Family Comprehensive Cancer Center. "This study will provide a unique opportunity to examine the immune response to PROVENGE in actual prostate cancer tissue and to examine the correlation between immune responses in the tissue versus those in the circulating blood."

"Given the evidence of a survival benefit seen in our previous Phase 3 trial, D9901, in patients with advanced prostate cancer, we believe PROVENGE may also have applicability to men with earlier stages of the disease. This trial will help us better understand the mechanism of action and biology of PROVENGE, as well as evaluate the potential of PROVENGE in patients at high-risk for recurrence of their cancer following radical prostatectomy," stated Mark Frohlich, M.D., senior vice president, clinical affairs and chief medical officer of Dendreon. "We are highly focused on taking the steps necessary to get PROVENGE through the FDA approval process in order to get this important immunotherapy to prostate cancer patients with advanced disease who do not have any other reasonable options. We are on track to complete the interim analysis of our ongoing Phase 3 IMPACT trial during the latter half of this year."

About Prostate Cancer

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases expected to be diagnosed in 2008, and approximately 28,660 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.

About Active Cellular Immunotherapy with PROVENGE

PROVENGE may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity.

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 is also developing an orally-available small molecule called Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters 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.

About UCSF

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. For more information, please see http://www.ucsf.edu.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further 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 http://www.sec.gov.

[GuHu1]

bin zwar kein chart spezie aber demnach werden die nächsten tage interessant.

http://stockcharts.com/h-sc/ui?s=DNDN&p=D&b=4&g=0&id=p874242…

[edelupolino]

Antwort auf Beitrag Nr.: 34.523.203 von GuHu1 am 16.07.08 19:30:00

du hast recht mit deinem hinweis:

wie schon so oft geht's um entscheidende charttechnische hürden, die aber nur genommen werden können, wenn die fakten stimmen; die wären:
1. Gold tritt zurück
2. oder ein vertrag mit 1 BP wird bald verkündet und kenner der szene kaufen schon vor
3. gute news stehen kurz vor der veröffentlichung (insider oder ihre verwandten) kaufen schon...
Ciao Ede

[Poppholz]

Antwort auf Beitrag Nr.: 34.523.203 von GuHu1 am 16.07.08 19:30:00

heute ist auf jeden Fall schon mal "interessant"

[GuHu1]

Antwort auf Beitrag Nr.: 34.553.404 von Poppholz am 21.07.08 17:51:10

yep, das ist es.

[GuHu1]

Antwort auf Beitrag Nr.: 34.554.770 von GuHu1 am 21.07.08 20:33:42

Form 4 just filed - Mitch sold a small # of shares to pay tax liability

http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5783…

[GuHu1]

http://www.washingtonpost.com/wp-dyn/content/article/2008/07…

[GuHu1]

http://stockcharts.com/h-sc/ui?s=DNDN&p=D&b=5&g=0&id=p683091…

[Fruehrentner]

gibts news oder neue gerüchte?

[GuHu1]

Antwort auf Beitrag Nr.: 34.565.011 von Fruehrentner am 22.07.08 22:19:36

bisher nichts neues zu den interims daten, nur gerüchte bzw. die angst der shorts, dass die neuen regeln zu nacked shorting weiter gefasst werden als bisher offiziel ( s. der eine oder andere link zuvor).

[Poppholz]

Antwort auf Beitrag Nr.: 34.565.011 von Fruehrentner am 22.07.08 22:19:36

in den letzten Wochen hat es ja auch keine News gegeben, die den Kursverfall gerechtfertigt hätten.

Sehe hier "nur" eine normale Gegenbewegung.

Langfristig bleibe ich natürlich positiv eingestellt.

[Uptick08]

Antwort auf Beitrag Nr.: 34.567.527 von Poppholz am 23.07.08 11:07:15

Wer macht das rennen...DNDN oder CEGE, oder alle beide?




Beide scheinen jedenfalls wieder schwer im kommen zu sein...

[GuHu1]

Antwort auf Beitrag Nr.: 34.567.527 von Poppholz am 23.07.08 11:07:15

Dendreon Expects Interim Data Analysis for Phase 3 PROVENGE IMPACT Trial in October
Wednesday July 23, 7:30 am ET

SEATTLE, July 23 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that it expects the Independent Data Monitoring Committee (IDMC) to review in October 2008 the interim analysis of overall survival relating to the Company's Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE® (sipuleucel-T). PROVENGE is the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. Should the pre-specified criterion for statistical significance be achieved, Dendreon would anticipate amending its Biologics License Application (BLA) based on these interim results. The initial BLA filing was based primarily on an improvement in overall survival observed in Dendreon's Phase 3 trial D9901, a multi-center, randomized, double-blind, placebo-controlled trial.

ADVERTISEMENT
Following the U.S. Food and Drug Administration (FDA) Advisory Committee vote that there was substantial evidence of efficacy of PROVENGE and that PROVENGE was reasonably safe, the FDA requested additional clinical data to support the proposed efficacy claim. The FDA has since indicated that either a positive interim or final analysis for overall survival from the IMPACT trial would be sufficient to address the request for additional information to support the proposed efficacy claim.

"We look forward to the interim results of the IMPACT trial this October. We are focused on providing the FDA with the additional data needed to obtain the regulatory approval of PROVENGE in an effort to rapidly bring this new therapy to the many prostate cancer patients who currently have few appealing treatment options. While the final analysis of the trial has a higher probability of success, the interim analysis provides us with the potential to accelerate our BLA amendment for PROVENGE," said Mitchell H. Gold, president and chief executive officer of Dendreon.

If the IDMC reports in October that the pre-specified criterion for statistical significance is not met, then the company anticipates continuing the trial with the expectation of reporting final results in the second half of 2009.

[GuHu1]

Antwort auf Beitrag Nr.: 34.565.011 von Fruehrentner am 22.07.08 22:19:36

nun die news siehe oben, second hand gerüchte wurden u.a. am 14.04 gestreut.

http://www.investorvillage.com/smbd.asp?mb=971&mn=206956&pt=…

gerüchte gibt es bekanntlich viele, darum immer schön vorsichtig bleiben und das risiko dabei bedenken.

[GuHu1]

Antwort auf Beitrag Nr.: 34.574.085 von GuHu1 am 23.07.08 23:45:45

http://www.investorvillage.com/smbd.asp?mb=971&mn=50231&pt=m…

[edelupolino]

Antwort auf Beitrag Nr.: 34.608.707 von GuHu1 am 29.07.08 19:11:08

Hi GuHu,
dazu passt noch etwas,das Dndn von anderer seite befeuern könnte:

Illegal Short Sellers May Face RICO Indictments

by: R.J. Chopin posted on: July 29, 2008

...Dick Fuld, CEO of Lehman Brothers (LEH), told market regulators that he has information that short-selling hedge funds colluded to bring down Bear Sterns (BSC). If Fulds's "information" is of evidentiary value, these hedge fund managers, and their cast of cohorts, could find themselves behind bars.

If the SEC diligently investigates the facts, we could see RICO indictments against illegal short sellers as early as Labor Day. Anyone charged under the RICO statue, even if they are found "not guilty," will become permanently damaged.

After observing the demise of Fannie Mae (FNM), and Freddie Mac (FRE) last week, it is expedient that the SEC move quickly to abolish the practice of naked short selling for all stocks. Short selling should only be allowed after the short seller has successfully borrowed the shares. The practice of selling shares that cannot be borrowed is a crime!

http://seekingalpha.com/article/87653

...fänd ich klasse, wenn ich einige von den neuen "racketeers" hinter gittern sehen könnte!
Ciao Ede

[GuHu1]

Antwort auf Beitrag Nr.: 34.609.394 von edelupolino am 29.07.08 20:33:30

jo ede,
aber letztenendes müssen die daten passen entweder oct 08 oder oct 09. Die anschließende diskussion zu den links ist ganz nett.

http://www.investorvillage.com/smbd.asp?mb=971&mn=208184&pt=…

Dendreon Holds Its Breath
Biotech, Provenge, Dendreon
Dendreon Holds Its Breath, Big Provenge Clinical Trial Result Coming In October
Luke Timmerman 7/31/08
Dendreon’s David Urdal never fails to give off the impression that he’s a ballast for the company, at least in the dozens of times I’ve interviewed him in the past seven years. The even-keeled chief scientific officer has lived through all the ups and downs since he joined the Seattle biotech company back in its early days in 1995.

Now Urdal, 58, is gearing up for another turning point in October. It’s from a clinical trial of 500 prostate cancer patients, known as Impact. The company (NASDAQ: DNDN) will find out if that trial can crank out the kind of evidence needed to convince the FDA it truly has a drug that can help prostate cancer patients live longer. If it does, the company will sprint to bring that drug, Provenge, to the market as the first treatment of its kind to stimulate the immune system to fight cancer cells. But if the early peek at the data—an interim analysis—shows results that could even possibly be due to chance, then everyone will have to wait in suspense one more year for a final verdict.

“I think people here now can feel the moment coming,” Urdal says. “We’re within a couple of months of knowing new information, and there’s a high level of anticipation and excitement about it.”

Provenge has captivated the imaginations of doctors, patients, and investors (and journalists) for years. The treatment, called an immunotherapy, or a cancer vaccine, doesn’t work like a traditional cancer drug. Blood is drawn from a patient, and some white blood cells vital to the immune system, called dendritic cells, are separated in a lab. The cells are shipped to the company and incubated with a genetically engineered protein found on prostate cancer cells, called PAP. The white blood cells are supposed to recognize the protein as an invader and recruit the immune system’s arsenal to attack tumor cells that contain it. The revved-up white blood cells are shipped back and re-infused into the patient.

Without going too long on the history—that’s a book-length project—Dendreon thought it had done enough to get Provenge approved by the FDA a year ago. It asked the agency to clear the product for the sale mainly on a study of 127 men that showed it could extend patients’ lives by a median time of 4.5 months, with minimal side effects, like fever and chills. An FDA advisory panel agreed in March 2007 that the drug was safe and “substantially effective.” The next day, Dendreon became the heaviest traded stock on the entire Nasdaq exchange, rocketing from $5.22 a share to briefly more than $20 after the panel vote, as investors were betting that the FDA would follow the panel’s advice and approve the drug, as it usually does.

The operative word in that last sentence is “briefly.” Dendreon crashed back to earth in May of last year. That’s when the FDA chose not to approve the drug, preferring to wait for more evidence from the ongoing 500-patient Impact trial. Almost $1 billion of stock market value evaporated in a heartbeat.

So Dendreon knows about ups and downs. Now it could be in for some more. …Next Page »
____________________________

http://www.investorvillage.com/smbd.asp?mb=971&mn=208185&pt=…

Dendreon Holds Its Breath, Big Provenge Clinical Trial Result Coming In October
Luke Timmerman 7/31/08
(Page 2 of 2)

The Impact study itself has been through a circuitous history. It was started in June 2003, and originally aimed to enroll patients with terminal prostate cancer who have moderate -to-less aggressive tumor types, as measured by a standardized “Gleason” scoring system. It was designed that way because earlier trials had suggested that Provenge didn’t work for patients with the most aggressive Gleason-rated tumors, so weeding them out would give the drug a better shot, Urdal says. The study also was primarily designed to see whether Provenge could slow down the spread of tumors, instead of waiting a longer time for data on whether it helped men live longer—the gold standard for cancer drugs.

Then in 2005, more data rolled in from the previous clinical trials suggesting that Provenge actually did extend lives, for all kinds of patients, regardless of Gleason score. So in November of that year, Dendreon agreed to an overhaul of the Impact trial, at the request of the FDA, Urdal says.

The changes were big. The new protocol called for Dendreon to enroll patients with all types of Gleason tumor scores. It switched the main goal of the study from the squishier and more debatable point of slowing tumor progression, to the more definitive measurement of survival time. It boosted total enrollment to 500 patients. And, it started allowing a slightly sicker kind of patient with bone pain into the study.

This October, then, the trial is designed to take an interim look after a certain number of deaths among the 500 men have occurred, which Dendreon hasn’t disclosed. Since it’s an early peek based on a small set of data, the analysis has to show Provenge patients are living longer than those on placebo, and demonstrate it with a higher degree of statistical certainty than normal to assure regulators that it isn’t a result of chance. If the interim analysis doesn’t clear that bar, then Dendreon expects it will have to wait another for 360 patients in the trial to die, so it can do the final survival analysis.

The analogy I used in my conversation with Urdal, which he agreed is a good way to think about it, is that an interim analysis is like taking a look at the standings half way through the football season, seeing an undefeated team, and saying it looks like they will win the Super Bowl. The final analysis is confirmation that they can hoist the Vince Lombardi trophy.

Right now, Dendreon’s contract research organization is in the middle of its season. It’s double-checking patient records to make sure no mistakes are made. By October, it will have collected the data and sent it to an independent monitoring committee. That group of experts will then make a recommendation to Dendreon on whether it should declare victory now and ship off a fresh new application to the FDA, or whether it should wait for the full analysis before it sends in its application.

Urdal doesn’t sound like he’s sweating the interim analysis. If the statistics don’t show the survival benefit the company needs right away, “then we’ll just have to wait another year.”

Of course, Dendreon is naturally working on a fallback plan in case the interim analysis fails to show a clear enough survival advantage. It is developing Provenge for earlier stages of prostate cancer, and it has other drugs on the back burner designed to use the same technique for breast, kidney, and colon cancers. Another drug discovered internally, trp-p8, is being prepared to enter clinical trials, Urdal says.

So is the interim analysis really a make-or-break moment for Dendreon? Not really, says David Miller, president of Biotech Stock Research, a Seattle-based equity research firm that covers the company. “It’s clear that (CFO) Greg Schiffman has financially positioned them in a way that they won’t get in financial trouble if the interim analysis doesn’t pan out,” Miller says.

Either way, Dendreon bulls and bears are certainly going to rev up their engines between now and October in hopes they can ride the shares up past $20 again, or short them down to something a whole lot lower than its closing price yesterday of $5.69.

[GuHu1]

auch nicht schlecht, ist was fürs wochenende.

http://www.investorvillage.com/smbd.asp?mb=971&mn=208533&pt=…

[GuHu1]

...... Something went awry. In February 2005, NCI gave endorsements like this:

As Dr. James Gulley, of the National Cancer Institute, said in the Washington Post, "This is a significant development. It is both meaningful for patients who have prostate cancer, but also for the field. It provides a proof of concept that vaccines, in fact, work."

http://www.accessmylibrary.com/coms2/summary_0286-3904441_IT…

NCI respects Dr. Eric Small, so what happened? From the same conference call:

Based on these data, Dr. Small indicated that the survival benefits seen with Provenge is the largest ever reported in this patient population with any therapy. This survival benefit, combined with a favorable safety profile has the potential to provide an important new treatment option for prostate cancer patients.

Well apparently our gov't works weekends now! In these e-mails Joe is talking about you will see that two days after the positive Provenge Advisory Committee panel vote, Howard Streicher and Alison Martin appear to have found themselves an emergency. They start e-mailing each other on Saturday, March 31st and continued it on Sunday, April 1st. How many gov't employees do you know work weekends? Usually, only in emergencies, right? They had an emergency on their hands. It appears they had to stop Provenge! They did this outside of the scope of their gov't jobs, no? They did this on their own time.

Can someone explain what Howard Streicher meant in his Sunday afternoon e-mail to Alison, April 1st, 1:40 PM. First, we would like to know what he found "Very interesting". Then he says:

"I was thinking of doing one of my own on the broader implications of having the FDA forum become the arbitor (sic) of what works; without even full disclosure of all of the evidence I must believe this process is deeply flawed-"

Is he saying we should go by his beliefs and not the full disclosure of the evidence?
Does he say all drugs approved by FDA should be called back because the process is deeply flawed?
Does he afford Taxotere the same reasoning since it was approved by FDA?
Is he debunking all Advisory Committees, even though he was unfamiliar with this one and what transpired?
Is he saying the Congressional mandated questions for approval are worthless?
Is he trying to say he would like to skip around Congressional oversight?

Then there is Dr. Niederhuber's letter to Senator Daniel Inouye. Dr. Niederhuber replaced Von E at NCI. It appears David Pugach sent it to Alison Martin and Howard Streicher late Thursday, July 12, at 6:18 PM. He said the letter is due on Monday. Sounds like they had to work on the weekend again.

The letter to the Senator is most telling. "The National Cancer Institute (NCI) is not supporting any research on this specific vaccine [Provenge]." Then it goes on to say, "NCI has a robust research portfolio in prostate cancer and provided $293.2 million in 2006." This support was to continue the same in 2007 and 2008.

If this agency is supposed to be fighting cancer and promoting cancer research, how does it decide what it will support and will not support? Shouldn't it support all options? Since it is our tax dollars at work here, shouldn't we have a say?

Later it says "NCI is also supporting other clinical trials for prostate cancer treatments that are studying a range of treatments for prostate cancer." It sounds like a wide range. How did that range miss Provenge?

"The prostate cancer research supported by NCI is very promising." And Provenge is not?

"Please do not hesitate to let me know should you have any additional questions regarding prostate cancer or any other area of cancer research."

Somebody in this Senator's district should tell him to ask the NCI how it decides what cancer treatments to support. Tell him to mention that the side effects of Provenge are flu like symptoms for two days but if you go to www.taxotere.com, when the web page pops up a black box comes up on your screen that shows you a scary warning! Streicher seems to endorse taxotere.

A few weeks ago I attended a prostate cancer support meeting. A newsletter was handed out and it talked about Ted Kennedy. Now let me make it clear, I feel very sorry for Ted. I don't wish cancer on anyone, even my enemies. I just list this to show the thought processes these folks have. Here it is:

[Senator] Kennedy, who worked closely with Republican Senator Kay Bailey Hutchison of Texas, plans to file the legislation in the coming weeks, an aide said. The bill seeks to improve coordination of cancer research, prevention and treatment while GIVING MORE MONEY TO THE NATIONAL CANCER INSTITUTE and other public research agencies.

Now to me, it doesn't seem like they are really interested in cures, only research. Cancer research is a cash cow. So it begs the question, is this another reason why Streicher and Martin and others at NCI helped stop Provenge from reaching 30,000+ men who had no other options? Is NCI debunking the FDA's reasoning behind granting Provenge Fast Track Status and Priority Review?

This bill Kennedy is working on is an overhaul of the 1971 National Cancer Act. He started overhauling it once he was diagnosed with cancer. A few weeks ago, he and Hutchison met up with Lance Armstrong calling on Congress and the country to step up the fight against cancer.

Amazing isn't it? Step up the fight after they shut down some good possibilities like Provenge and Junovan! NCI hurt the advancement of immunotherapy. If these two treatments were approved, no need to GIVE MORE MONEY TO NCI! Isn't this what this is all about? Follow the money and you'll see why the patients be damned!

Hey Joe, bad title for your blog! Go ask some questions over there at NCI and report back to us. And go talk to Howard Scher about all of his investments. Go talk to Richard Pazdur and discuss his business relationships. Find out the real reason these guys stopped Provenge over a year ago. Follow the money.

http://blog.seattlepi.nwsource.com/thelifesciencesblog/archi…

[GuHu1]

http://fdanews.com/newsletter/article?issueId=11832&articleI…

[edelupolino]

Antwort auf Beitrag Nr.: 34.656.084 von GuHu1 am 05.08.08 23:26:04

...da haben wir sie wieder: dieselbe üble story über verstrickungen, neid und eitelkeiten, die das wichtigste brutal ausblenden:

das wohl des patienten,

das angeblich in der medizin das höchste gut ist.

Je länger ich das Provenge-Drama lese, um so mehr zweifle ich an der intelligenz des "führungspersonals"; sogar der vom krebs getroffene Kennedy will einer untätigen behörde (NCI) noch mehr forschungsgelder geben - unfassbar!!!

...und diese typen wissen, dass es Provenge gibt!

[Poppholz]

heute so ruhig hier?

USA steigt um 5%

[NoSelters]

http://www.investorvillage.com/smbd.asp?mb=971&mn=209527&pt=…

[GuHu1]

2nd Quarter Cash Burn
Looks like it will be lower. That is a good thing.

News for 'DNDN' - (*DJ Dendreon 2Q Loss/Shr 18c Vs Loss 27c >DNDN)


(MORE TO FOLLOW) Dow Jones Newswires
August 11, 2008 16:19 ET (20:19 GMT)
Copyright (c) 2008 Dow Jones & Company, Inc.- - 04 19 PM EDT 08-11-08

Source: DJ Broad Tape

http://www.investorvillage.com/smbd.asp?mb=971&mn=210080&pt=…

[GuHu1]

SEC closes Dendreon inquiry
The Securities and Exchange Commission has completed an inquiry into Dendreon Corp. and won't take any action, Dendreon said in a filing today.

Last July, Dendreon said that the SEC had opened an informal inquiry, which the company said "appears to be related to disclosures regarding the approval process for Provenge and trading in the Company's stock."

Several lawsuits filed by investors last year alleged that the company and some of its directors violated securities laws by omitting material information about Provenge (the company's lead product) and benefited by selling stock at an artificially high price.

In April, a federal judge granted Dendreon's motion to dismiss the lawsuits -- which were consolidated together -- although plaintiffs in the case have since amended their complaint.

Today's statement by the company is straightforward:

On August 6, 2008, we received a letter from the New York Regional Office ("NYRO") of the SEC notifying the Company that NYRO's previously disclosed informal inquiry has been completed and that NYRO does not intend to recommend any enforcement action by the SEC.

http://blog.seattlepi.nwsource.com/thelifesciencesblog/archi…

[GuHu1]

Dendreon Initiates Second of Two New Phase 2 Trials

SEATTLE, WASHINGTON, August 14, 2008 — Dendreon Corporation (Nasdaq: DNDN) today announced that the Company has initiated its second of two new Phase 2 trials of PROVENGE® (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. The multicenter trial, called ProACT (PROstate Active Cellular Therapy), has begun enrolling 120 patients with metastatic, androgen independent prostate cancer.

All patients will receive active treatment but will be randomized into one of three cohorts which will receive PROVENGE manufactured with different concentrations of the immunizing antigen. Patients will receive three infusions of PROVENGE, each two weeks apart. The trial is being conducted by Dendreon to explore the effect of antigen concentration on CD54 upregulation, a measure of product potency, as well as the immune response. Overall survival data will also be collected. The enrollment criteria are essentially the same as the criteria for the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) study, which completed enrollment in October 2007 and, upon receipt of positive data, will serve as the primary study for amending Dendreon's Biologics License Application (BLA) for PROVENGE.

"We are grateful for the continued support from patients, physicians and patient advocates and are pleased to be able to provide them with access to PROVENGE while we await results from the IMPACT trial," stated Mitchell H. Gold, president and chief executive officer of Dendreon.

ProACT is the second of two studies the Company is initiating. Dendreon recently announced it had begun enrolling patients in a 40-subject, single-center trial called NeoACT (NEOadjuvant Active Cellular immunoTherapy), or P07-1, which is being conducted at UCSF Helen Diller Family Comprehensive Cancer Center.

About Prostate Cancer

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases expected to be diagnosed in 2008, and approximately 28,660 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.

About Active Cellular Immunotherapy with PROVENGE

PROVENGE may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity.

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 is also developing an orally-available small molecule that targets Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters 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 www.dendreon.com.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further 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.

Contact Information:
Jennifer Williams
Investor Relations
Dendreon Corporation
206-829-1500

Katherine Stueland
WeissComm Partners
[phone]

[GuHu1]

http://seekingalpha.com/article/90876-updates-on-the-healthc…

[GuHu1]

Antwort auf Beitrag Nr.: 34.728.401 von GuHu1 am 14.08.08 16:11:20

http://biz.yahoo.com/zacks/080815/14242.html?.v=1

[GuHu1]

so nun ist mit cege der letzte potentielle konkurrent zu dndn`s provenge ins straucheln geraten ( inwieweit das straucheln folgen hat wird sich zeigen).

machen wir es kurz, anbei einige stellungnahmen dazu.

http://biz.yahoo.com/ap/080827/cell_genesys_gvax.html?.v=1
___________________________

Re: Cell Genesys Halts VITAL-2 GVAX Trial in Advanced Prostate Cancer/Conference Call Scheduled for 8:30 a.m. ET Today Aug. 27, 2008 11:10 UTC
Cell Genesys Halts VITAL-2 GVAX Trial in Advanced Prostate Cancer
Conference Call Scheduled for 8:30 a.m. ET Today

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Cell Genesys, Inc. (Nasdaq:CEGE) today announced that it has terminated VITAL-2, the second of two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, which compares GVAX immunotherapy in combination with Taxotere® (docetaxel) to Taxotere plus prednisone in patients with advanced-stage prostate cancer. The Company ended the trial as recommended by its Independent Data Monitoring Committee (IDMC) which, in a routine safety review meeting held this week, observed an imbalance in deaths between the two treatment arms of the study. To date, VITAL-2 enrolled 408 patients. The IDMC based its recommendation on 114 deaths of which 67 occurred in the GVAX plus Taxotere combination treatment arm and 47 deaths occurred in the Taxotere control arm. At this time, a specific cause for the imbalance in deaths has not been identified and the IDMC reported no new safety issues for GVAX when administered in combination with Taxotere. The Company plans to fully analyze the clinical data from these patients to attempt to understand the potential cause for the higher rate of deaths observed in the GVAX immunotherapy plus Taxotere combination arm, including an assessment of potential imbalances between the two arms of the study such as baseline characteristics and prognostic factors, as well as other treatment variables. In light of the IDMC’s observation with respect to VITAL-2, the Company has requested that the IDMC perform a previously unspecified futility analysis of VITAL-1, the other Phase 3 clinical trial of GVAX immunotherapy for prostate cancer. The Company expects the results of the VITAL-1 futility analysis in approximately one month.

\"Patient safety is always our paramount concern and so we have immediately responded to the recommendation of the IDMC. We are currently notifying all participating clinical trial sites and regulatory agencies that enrollment of new patients into VITAL-2 has been suspended as has treatment with GVAX immunotherapy for prostate cancer of patients enrolled in the study,\" stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. “Notwithstanding this disappointing outcome, we would like to acknowledge the courage and commitment of the patients and physicians who have participated in this trial.”

Dr. Sherwin continued, “The observation in the VITAL-2 trial is very surprising to us, and we have therefore asked the IDMC to conduct a previously unplanned futility analysis of VITAL-1 in order to determine the overall prospects for our ongoing development program for this product. Moreover, with the cessation of VITAL-2, we expect to make commensurate adjustments to our business operations and we will provide further details regarding this in the near future. As a reminder, the company ended the second quarter of 2008 with $166 million in cash.\"

VITAL-2 was a multi-center, randomized, controlled Phase 3 clinical trial designed to evaluate the safety and efficacy of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the use of Taxotere chemotherapy and prednisone in hormone-refractory prostate cancer (HRPC) patients with metastatic disease who are symptomatic with cancer-related pain. The primary endpoint of the trial was an improvement in survival. VITAL-2 was initiated in June 2005 and to date had enrolled 408 patients at 115 clinical trial sites located in North America and the European Union. VITAL-1, the other Phase 3 clinical trial of GVAX immunotherapy for prostate cancer, is designed to compare GVAX cancer immunotherapy as a monotherapy to Taxotere chemotherapy plus prednisone in earlier stage HRPC patients with metastatic disease who are asymptomatic with respect to cancer-related pain. The primary endpoint of the trial is an improvement in survival. In 2007, the VITAL-1 trial completed enrollment with 626 patients. In January 2008, Cell Genesys announced that the IDMC had completed a pre-planned interim analysis for VITAL-1 and recommended that the study continue, providing no further information to the company other than the recommendation to continue the trial.

Conference Call and Webcast

Members of the Cell Genesys management team will host a conference call today, Wednesday, August 27, 2008, at 8:30 a.m. ET to discuss the IDMC\'s recommendation. Investors may listen to the webcast of the conference call live on the investor section of the Cell Genesys website, www.cellgenesys.com. Alternatively, investors may listen to a replay of the call by dialing [phone] from locations in the U.S. and [phone] from outside the U.S. The call-in replay and webcast will be available for at least 72 hours following the call. Please refer to reservation number 958709.

About GVAX Immunotherapy for Prostate Cancer

GVAX immunotherapy for prostate cancer is comprised of two prostate tumor cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine that plays a key role in stimulating the body\'s immune response, and then irradiated for safety. GVAX immunotherapy for prostate cancer is designed to be administered through intradermal injections on an outpatient basis.

_______________________________________________________

Wednesday, August 27, 2008

CEGE; Cell Genesys Halts a Trial, Good Time to Trade?
Back in May we got a nice surprise from Cell Genesys Inc (CEGE) when the stock rose to the mid fours after an announcement that Cell Genesys had found a partner and financial backer in Takeda Pharmaceuticals.

Things were looking for CEGE. They were in good financial shape and their two Phase III GVAX trials were progressing nicely. Although about a year behind Dendreon\'s (DNDN) Provenge, GVAX was poised to mount a battle with Provenge for market share of future prostate cancer treatment.

Today things just took a turn for the worse for GVAX and investors in CEGE (investors that were not short). Cell Genesys was forced to halt their VITAL-II trials of GVAX after their independent monitoring committee noted a higher rate of deaths among patients that received GVAX with Taxatore than those that received just Taxatore. The technical quote from the Press Release: The Committee \"observed an imbalance in deaths between the two treatment arms of the study.\"

Shares of CEGE are trading in the seventy cent range after dropping a drastic 75% on the news.

Cell Genesys CEO Dr. Stephen A. Sherwin stated that these findings were, according to the Press Release, \"very surprising to us, and we have therefore asked the IDMC to conduct a previously unplanned futility analysis of Vital-1 in order to determine the overall prospects for our ongoing development program for this product.\"

According to the company, they will know the possible cause of the increased deaths in the Taxatore-GVAX arm in approximately one month.

It\'s possible that the problem is the combination of the two treatments, and not GVAX alone, as GVAX has been well-tolerated on it\'s own, according to previous results. Vital-1 passed an interim look, and that trial is still ongoing.
We\'ll most certainly hear an update on Vital-1 after the independent committee revisits that trial.

Regardless of the outcome, GVAX will have this stigma attached to it forever, unless there is a completely unrelated cause for the increased deaths.

As for the CEGE stock, it\'s a sure bet that the big boy investors in the stock were tipped off about this news before today and had the chance to get out last week. Others would have taken the opportunity to short the stock, adding to the downward pressure we\'re seeing today. The stock is down roughly 75% on huge volume (over seven times average as I type).

While I would expect a huge drop on this news, I believe trading under a buck is overkill. GVAX has been well-tolerated before, and the Vital-1 trial is still ongoing. I\'m going to wait this one out and see what comes of the investigation and the further look into Vital-1. I also expect some volatility in CEGE over the next month, to take advantage of so I\'ve doubled down at 74 cents to have some trading shares.

I\'m not ready to call GVAX a complete failure just yet.

Cancer therapies are dropping like flies lately, but we still have the big interim results news expected from Dendreon within the next couple of months.

Investors and patients alike eagerly await the interim results of Dendreon\'s Phase III trials for Provenge. The FDA has indicated that they may grant approval of Provenge based on these interim results.

There\'ll be a few investors in CEGE that will want to get the stock back over a buck sometime soon in anticipation of more news. The stock may go lower in the short term, but I\'m pretty confident we\'ll rebound as the shorts will need to cover. In my opinion, Cell Genesys and GVAX are in a lot better position right now than Vanda (VNDA), yet VNDA still trades over a buck after a similar drop when the bad news about Iloperidone was released.

You\'ve got to have stomach to play with CEGE right now, but VFC likes the game. I\'m playing the drop-rebound play here.

On days like today, shorts make a killing and the afeared little guys sell out!

http://vfcsstockhouse.blogspot.com/2008/08/back-in-may-we-go…

___________________________________________________________________

[GuHu1]

das folgende kann ich mir fast gar nicht vorstellen, was macht der partner von cege wenn das folgende zutrifft?

http://www.investorvillage.com/smbd.asp?mb=247&mn=467&pt=msg…

EINE ansicht aus dem IV dazu (cege board):

Re: Trial Halted?
In my opinion, CEGE has been withholding data on the adverse events resulting from GVAX so that their friends could bail out of the stock before it crashed today.

Several months ago the Independent Data Safety Monitoring board reviewed the data and recommended continuing the trial. Now we learn that more than sixty people in the trial died. Are we expected to believe that they didn't know about this long ago?

I expect to see class action law suits to be filed soon. They deserve to get their a... sued.
Admittedly it is not as bad for the investors as for those who took their drug.

[GuHu1]

As The Days Go By

Remember at the Provenge Advisory Committee hearing when Mr. Howard Scher said the following (page 322 AC transcript):

"So I say well, what if we think that this really should be available, start thinking about the number of agents that are currently under development."

Well, I took it to mean:

"So I say well, what if we think that this (Provenge) really should be available, start thinking about the number of agents (Asentar and GVAX) that are currently under development."

That was because Scher was leading the Asentar trial for Novacea and did Phase I work for GVAX. Then he told Marilyn Chase he did free work for Bristol-Myers Squibb (BMY) which I am sure made BMY investors very happy as well as Richard Pazdur who has a close friend who is a lobbyist for BMY. It turns out BMY was working with Medarex on a compound called ipilimumab which was being used to develop GVAX
(see http://www.cellgenesys.com/clinical-prostate-cancer.shtml).

Then remember what Thomas Fleming wrote in a letter to the FDA that eventually got leaked to the Cancer Letter about 4 days before the CR Letter came out:

"In a letter to FDA in the April 13, 2007 Cancer Letter, Howard Scher of Memorial Sloan-Kettering Cancer Center presented valid and compelling arguments that FDA await the completion of an ongoing 500 patient (9902B) Phase 3 trial before deciding whether to approve Sipuluecel-T in prostate cancer patients. Reportedly, Scher felt motivated to write the letter after being kept awake the night following the March 29, 2007, FDA Cellular, Tissue and Gene Therapies Advisory Committee by the thought that if Sipuluecel-T were approved, patients may well forego more effective treatment alternatives."

Well, I took it to mean:

"Scher felt motivated to write the letter after being kept awake the night following the March 29, 2007, FDA Cellular, Tissue and Gene Therapies Advisory Committee by the thought that if Sipuluecel-T were approved, patients may well forego more effective treatment alternatives like Asentar and GVAX."

So now here we are today. Asentar was stopped on November 5, 2007 and GVAX was halted today, August 27, 2008. Mr. Scher stopped Provenge for two agents under development which are now swept under the carpet. And this guy and Fleming are the ones FDA chose to listen to? Now I really want to see Scher's personal opinion which he sent to Alison Martin that the folks at NCI omitted in the FOIA documents. These people have a lot of nerve.

How silly is it that FDA listened to a quack who said this:

"Personally I have no experience with this agent (Provenge), so I'd just like to ask clinicians who have used it." -Mr. Scher (page 87 AC transcript)

Why didn't he and FDA listen to Dr. David Penson who administered the Provenge treatment? He spoke at the AC hearing.

"This is not like classic chemo; there is no loss of hair, no sickness associated with it. We are disappointed because I think that many of the people who are involved in the study, many of the site investigators who are experienced with the drug, feel that it's a safe drug and that it works...that it extends life in a very desperate group of patients." -Dr. David Penson

http://www.investorvillage.com/smbd.asp?mb=971&mn=212600&pt=…

[tom148]

Antwort auf Beitrag Nr.: 34.884.878 von GuHu1 am 27.08.08 23:03:35

Bei 408 todkranken Patienten läßt sich die Zeitspanne des Weiterlebens doch gar nicht genau auf den Tag diagnostizieren. Mag sein, dass die mit GVAX behandelten Patienten in der Überzahl unerkannterweise einfach schwerer erkrankt waren. Mag sein, dass das Immunsystem, unterstützt durch GVAX, sich gegen die, durch die Chemotherapie verursachten körperlichen Auswirkungen, zur Wehr setzte und sich die Behandlung so gegenseitig aufhob bzw. zu einem Zusammenbruch führten, weil die Patienten in dem Spätstadium einfach überfordert wurden.
Der positive Effekt, nämlich dass GVAX im Frühstadium der Krankheit hilfreich sein kann, wird sich letztendlich durchsetzen. Was wir im Kursverlauf sehen, ist ein Leerverkauf bis zum "Geht nicht mehr". Wegen dieses Ergebnisses sind die Forschungsresultate als zukunftsbezogene Hoffnungsträger ja nicht weniger wert. Könnte eine gute Einstiegschance sein - erstmal abwarten.
gruss
tom

[GuHu1]

Antwort auf Beitrag Nr.: 34.885.661 von tom148 am 28.08.08 01:54:09

auf die mag seins will ich nicht eingehen.

ich habe nicht gesagt das cege gestürzt ist, ich sagte cege ist gestolpert und welche auswirkungen das letztlich haben wird, werden wir sehen.

die eingestellten beiträge sind ein rundumschlag zu dem was mir so in die finger gefallen ist.

[GuHu1]

AAAAAHHHHHHHHRRRRR $%&?=@, was ist denn jetzt los.


thestreet.com
http://www.thestreet.com/_yahoo/newsanalysis/stockpickr/1043…

Next up is Dendreon (DNDN), a well-known biotechnology company focused on the discovery, development and commercialization of therapeutics that harness the immune system to fight cancer. This biotech has literally been left for dead. Shares of Dendreon plunged back in May 2007 after the FDA asked for more information regarding its lead prostate cancer drug Provenge, despite the recommendation of the drug from the advisory board. Shares were once as high as $25 but now trade for around $6 a share.

Investors are now looking forward to an Impact phase III study due out in October on Provenge that will show how long the drug can keep patients alive as compared with a placebo. The final results of the study are set to be released in the second half of 2009. However, if the October trial can hit the interim data goals, Dendreon will most likely apply for Provenge's biologics license application, which will move up the approval process with the FDA.

The thing I really like about Dendreon is the fact that Wall Street seems to have absolutely no love for this stock. Currently, all eight analysts that follow Dendreon rate the shares a hold or sell. Combine that with an ungodly large short position that makes up around 36% of the tradable float and you have one despised stock.

The question that needs to be asked is: Why haven't the short-sellers walked away from this after the huge drop that occurred in 2007? Maybe they'll need to ask themselves that question once the gigantic short squeeze begins! Sue me for being an optimist, but I expect positive results in October -- especially when you consider that the FDA's advisory board already voted once 17-0 that the drug was safe and effective.

[edelupolino]

Antwort auf Beitrag Nr.: 34.953.403 von GuHu1 am 02.09.08 22:04:48

Hi GuHu,
Das liest sich sehr hoffnung-erweckend, aber wir sind gebrannte kinder.
Wer traut sich noch, von seinem geliebten biergeld nachzulegen?? Die fässer im keller sind sicher, die zweifel nach Cege lassen kaum neue käufe zu.

...hab mir zwar vor wochen noch ein paar Dndn gekauft, aber ich trau mich ehrlich gesagt nicht mehr, trotz der einsicht/des wunsches, dass selbst die geldgierigsten Ami-betrüger-ärzte DIESES mittel von DIESER firma brauchen und sich von ihrem urologen verabreichen lassen.
Ciao Ede

[GuHu1]

Antwort auf Beitrag Nr.: 34.965.563 von edelupolino am 03.09.08 17:14:13

Wer traut sich noch, von seinem geliebten biergeld nachzulegen??

hi ede,

keine frage, vorsicht ist die mutter ......
ich will auch keinen zum kaufen animieren, stelle nur die sich ändernden sichtweisen ( z.b. thestreet.com) ein. ich finde es auch spannend wie sich dieser krimi entwickelt.

wer ist da nicht alles auf der strecke geblieben:
GPC, Novacea und jetzt könnte es auch cell genesys treffen.

das risiko bei dndn bleibt weiterhin hoch für mich bei 50:50 zu den interims im oktober.

grüße guhu

[NoSelters]

Hi...Ihr tapferen Dendreoniten.

Wie die Zeit vergeht. Eineinhalb Jahre schon!
Gelegenheiten zum etwas aufstocken gabs ja zur Genüge.

Schaun ma mal was die 50% Chance uns im Oktober beschert.
Wenns nicht hinhaut dann nochmals Krimi in ca. einem Jahr.
Dann aber mind. 80%....

Grüße und Good Luck !!!

[GuHu1]

Antwort auf Beitrag Nr.: 34.968.606 von NoSelters am 03.09.08 20:42:38

jo no,

so sei es.

[NoSelters]

Nur mal so nebenbei...

Seit dem letzten Durchbrechen der $5,50-Marke vor ein paar Wochen hat unsere Dendreon unabhängig vom Kurs rund 12% dazugewonnen!!

Was der Dollarkurs so ausmacht...

Grüsse

So Looong...

No

[NoSelters]

Anmerkung:

Sind natürlich Peanuts,verglichen mit dem was uns bevorsteht....egal in welche Richtung.


No

[GuHu1]

ich hatte ja zwischenzeitlich die offenen jobs bei dndn gepostet.
sind einige dazu gekommen und scheinbar auch schon besetzt worden.

neueste stellenausschreibung:

Training Coordinator Seattle WA Regular Full Time

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.139.717 von GuHu1 am 16.09.08 23:55:37

Hört sich gut an, ich bleibe so oder so dabei, d.h. 50 % Chance im Oktober und falls die Daten nicht für eine sofortige Zulassung ausreichen, nochmals die Chance ein Jahr später!
Ich glaube die FDA ist den Prostatakrebskranken eine Zuslassung schuldig und wenns den Betroffenen nur minimal was bringt! Nur meine Meinung!

[GuHu1]

Antwort auf Beitrag Nr.: 35.151.585 von Magnetfeldfredy am 17.09.08 17:00:20

Fight The Shorts!


Liz Moyer, 09.17.08, 11:55 AM ET
After riding out a brutal rout in the U.S. stock market, and the significant downdrafts in shares of major financial companies in recent weeks, the Securities and Exchange Commission is stepping in to put a stop to manipulative trading.

Is this Christopher Cox's profile in courage? Not so much.

Starting Thursday, traders will have to adhere to a new set of rules aimed at eliminating naked short-selling, an abuse that can have a debilitating effect on a stock. Options-market makers will no longer enjoy the exemption they had from existing rules. All traders will have to follow stricter delivery and borrowing requirements or face penalties. Traders who deceive their brokers about whether they have followed delivery and borrowing rules could face fraud charges.

There is still room for abuse, however. Day traders still have wiggle room to naked short-sell because they can close out their trades before the three-day delivery window closes. And the SEC still hasn't revived the uptick rule.

Critics have long said the SEC fails to enforce its existing rules related to short-selling and has dragged its feet for years on tightening those rules. Still, Cox is eager to look proactive now that the financial markets are melting down, and it probably helped that prominent executives, including Lehman Brothers' (nyse: LEH - news - people ) Richard Fuld, have complained to the SEC about short-sellers.

"These several actions today make it crystal clear that the SEC has zero tolerance for abusive naked short-selling," Cox said Wednesday.

The new rules extend to all U.S. stocks, not just the 19 financial companies covered in an emergency order the SEC put in place this summer to restrict unbridled short-selling in major banks and broker dealers.

That emergency order, which hedge funds fought hard to lift, expired in August; since then, traders have hammered stocks of Lehman Brothers, Fannie Mae (nyse: FNM - news - people ), Freddie Mac (nyse: FRE - news - people ), American International Group (nyse: AIG - news - people ), Merrill Lynch (nyse: MER - news - people ) and others.

Of course, the argument in favor of the stocks' decline is that the companies were in trouble and traders were merely acting rationally.

In short-selling, a trader borrows shares and then sells them, hoping to profit by buying them at a lower price later to close out the loan. Under existing rules, traders have to confirm that the shares are at least available for a broker or dealer to borrow (the locate rule), and they are supposed to conform to the conventional three-day window to deliver shares to the trader on the other side of the transaction.

In naked short-selling, the locate rule and the delivery rule go out the window, since the trader doesn't borrow the shares to begin with. That, and the absence of a rule requiring short sales to be done on a stock's uptick, gives plenty of ammunition to a trader intent on driving a stock into the ground.

Until very recently, the whole issue was dismissed by some as the fantasy of small-company chief executives who were trying to pin the blame for their management failures on mythical market forces.

Prominent short-sellers like Kynikos Associates' James Chanos mock the claims of Overstock.com's (nasdaq: OSTK - news - people ) Patrick Bryne that naked short-selling is destroying the U.S. markets. Bryne has waged a three-year campaign to get the SEC to tighten borrowing and trade settlement rules and, perhaps more urgently, actually enforce them. Chanos, who dismisses naked short-selling as hogwash, led the fund industry's push to get the SEC to drop the restrictions this summer. He says they "will inflict substantial damage on the U.S. equity markets."

The new rules announced Wednesday will be opened for comment. In the past, the agency has been flooded with letters from ordinary investors begging it to put a stop to naked short-selling.

Still, it's a bit of vindication for Byrne, whose self-styled jihad on naked shorting has brought him no end of ridicule and the repudiation of even his own father, John J. Bryne, a close friend of Warren Buffett's who made his name and fortune in the insurance business. Jack Bryne quit as the chairman of his son's company two years ago in disagreement about Bryne's war on naked short-selling.

The elder Byrne said in an interview last month that he regrets not supporting the campaign. "I wish I would have said publicly--and to my friends, there's something to what he says, don't bet against him."

http://www.forbes.com/wallstreet/2008/09/17/sec-naked-shorts…

[GuHu1]

Antwort auf Beitrag Nr.: 35.155.194 von GuHu1 am 17.09.08 20:04:20

http://www.cnbc.com/id/26759278/site/14081545?__source=yahoo…

Dendreon's "Naked Shorts" Running For Cover?
Posted By:Mike Huckman
Topics:Stock Market | CEOs and CFOs | Pharmaceuticals
Sectors:Health Care Equipment and Services | Health Care | Pharmaceuticals
Companiesendreon Corp

Some readers will accuse me of finding any old excuse to write about Dendreon, which as I've blogged before always results in a spike in page views.

But on a day when nearly all of biopharma is under pressure again due to market forces, it's truly worth calling attention to the fact that volatile shares of DNDN [DNDN 5.69 0.48 (+9.21%) ]are sustaining a decent-sized rally on much higher-than-normal volume.

About a third of the outstanding shares are sold short. In other words, they're held by investors who think the stock is going down. A couple of analysts I talked to think some of the shorts might have been spooked this morning when the SEC announced its crackdown on a certain type of short-seller provocatively known as "naked shorts."

Indeed, the shares spiked right around the time Jim Cramer was on CNBC talking about the significance of the harsh new rules.

Cramer: Finally, the SEC Takes Action
The only news today out of DNDN is that CEO Dr. Mitch Gold is going to present at the UBS Global Life Sciences Conference next Monday. His appearance comes just days or weeks ahead of the highly anticipated and controversial mid-term study results that DNDN says it'll release sometime next month.

This is the major clinical trial of the company's prostate cancer treatment Provenge. If enough men in the test live long enough, DNDN has said the Food and Drug Administration might approve the therapeutic vaccine based on the interim data. Otherwise, investors and patients will have to be patient at least until next year when the final results could come in.

The analysts I talked to say there will be trading days like this one as the DNDN D-day approaches and that the shares could continue to rally as more shorts take cover and other investors buy the stock outright on a bet the interim results might be good enough. I'm not aware of a single analyst who thinks they will be. So, as always, caveat emptor.

[GuHu1]

http://www.dendreon.com/dndn/career_opps

nett, offene stellen von 5 auf 18.

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=216584&pt=…

user rufustoehee IV:

After Schiffman's last presentation ( http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=DND… I had some questions. I sent them to Mr. Schiffman but got a response from Jennifer Williams in IR. This gal is good. Her responses are in red:

Dear Mr Schiffman,

I'm having trouble finding the Provenge plus Taxotere KM plot that Dr. Petrylak presented. Seems that that website is no longer active. Would some one be able to email the slides of that presentation or the KM curve of Taxotere plus Provenge? I believe you will find what you're looking for at this link. If you do not, please let me know. http://www.chemotherapyfoundationsymposium.org/meeting_archi…

At the Sept 4 presentation you said that from the leukapheresis cell separation techniques were used to isolate the APCs before activation. It was my understanding that the whole leukapheresis was exposed to the GM-CSF/PAP activation process. Are the APC cells separated and wouldn't it make more sense to activate the whole leukapheresis in order to expose other cells to the process (eg. NK cells-research shows that "cross-talk" between DCs and NK cells activates both, and wouldn't exposing T cells to the cassette be a form of adoptive T cell therapy, Rosenberg and Restifo have shown that a vaccine and adoptive T cell therapy have synergies)?
The leukapheresis product is shipped to a Dendreon manufacturing facility where it is processed by buoyant density centrifugation. The composition of cells following this process is very similar to the leukapheresis product. That is, in addition to Antigen Presenting Cells, sipuleucel-T contains other cell types including T cells, B cells and NK cells. We agree with you - we think it is advantageous to expose T cells to the activated, antigen-loaded APC. The process is described in more detail in Small et al. Journal of Clinical Oncology 18:3894 (2000) and in the briefing document that we provided to the FDA for our Advisory Committee Meeting in 2007 and which is available through the FDA web site.

A significant body of literature proposes that using chemo in smaller less toxic doses to exploit its immune stimulation properties rather than solely its cytotoxic properties would be more logical (eg Apetoh and Finn). The immune modulating properties of Taxotere are well documented (eg. LPS mimetic, TLR4 stimulating, release of HMGB1, HSP70 and HSP90 from apoptotic cells and its antiangiogenic effects even at low doses). Has Dendreon explored this issue and do they have any data relative to this? Did all of the 3 yr. plus survivors of 01 and 02a complete the full regimen of Taxotere (once every 3 weeks for 10 cycles)?
We have been following this literature and agree with the belief that chemotherapy and immunotherapy will prove to be complementary. In support of this idea, Dr. Petrylak presented an analysis of our sipuleucel -T data at the Chemo Foundation meeting in November 2006 and at AUA in May 2007 where our data suggest that prostate cancer patients who received sipuleucel-T followed by docetaxel had prolonged survival.

From an earlier call I recall that the Halabi numbers for IMPACT were 21.4 but at the Sept 4 call you said that the Halabi score for IMPACT is around 4 months better than 9901. That would make the Halabi score for IMPACT 24.1. Is this correct?
I listened to the webcast as well, and it was hard to understand, but no, the Halabi score for IMPACT is consistent with the prior study and is not four months better.

At Dr. Provost's presentation before CTGT in 06 she showed whisker plots that showed the CD54 upregulation of the different trials and they showed that the upregulation for IMPACT at that time was close to the upregulation for P11. Has there been any update of these graphs and is that relationship still comparable to those values presented by Dr. Provost.
There has not been an update to these graphs.

Many Thanks,

Dr. Rufus

[edelupolino]

Antwort auf Beitrag Nr.: 35.176.309 von GuHu1 am 18.09.08 21:51:24

Hört sich gut an!

U.U. steigt der kurs -neben den bald kommenden ergebnissen- auch deshalb, weil immer mehr ernst zu nehmende kenner der finanzwelt gegen "NSS" angehen. Heute stand sogar einiges darüber in der "Welt", dass die SEC hedgefonds, die diese üble methode wohl auch gegen Lehmann etc angewendet haben, stärker an die kandare nehmen will (offenlegung ihrer "short"-bestände z.B.)

Wie üblich stellt sich jetzt die frage, ob ich schon mal was verkaufe, um z.B. ein paar Ford zu kaufen...oder ob ich lieber noch abwarte, bis ein ganzes bündel positiver nachrichten Dndn endlich in die höhen treibt, wohin sie gehört!

[ossi67]

Hallo zusammen,

bin auch noch mit einem Teil dabei.

Diese Abhandlung fand ich gestern ganz interessant (hab ich aus einem anderen Thread).

und DNDN ist auch auf der SHO-Liste

++++++++++
Kursmanipulation und Gegenmaßnahmen

...angenommen, du kaufst 1000 Aktien eines Stocks. der manipulative MM, der diesen Trade für dich ausführt, kann diese 1000 Aktien sofort leihen und bereits einen Trade später gegen dich einsetzen, indem er diese 1000 Aktien ins bid verkauft, also billiger. da die Umsätze erst nach 3 tagen gecovert werden müssen (also abgerechnet), kann der MM mit dem gesamten (kauf)Volumen ins bid gehen und somit eigentlich kaufwillige abhalten, weil die sich natürlich fragen " wer verkauft denn da zu diesen Schweinepreisen?" , was dazu führen kann, dass trotz guter News ein stock nicht steigt oder sogar fällt.

Wenn das von mehreren MM betrieben wird, ergibt sich im Handel ein verzerrtes bild der Realität. eigentlich ist der stock bereit zu steigen, wird aber dadurch das die Shares der Ask Käufer sofort wieder billiger ins Ask gegeben werden, im lauf ausgebremst und fällt sogar. dieses spiel kann diverse tage so gehen und die Anleger richtig Geld kaufen. viele verkaufen am gleichen tag oder spätestens nach 2-3 tagen entnervt ihre " fallenden" Aktien, was dazu führt, das der preis noch weiter fällt. Netter Nebeneffekt für die Shorts: bei fallenden Kursen sammeln sie links und rechts noch Stop Losses ein und die abends nach hause kommenden Shareholder fragen sich, wo ihre Aktien geblieben sind. flankiert wird dieses vorgehen oft von Bashern, die zuhauf in den Boards auftauchen und dort die Verunsicherung weiter schüren.

Nun wurde zum Jahreswechsel ja die SHO Regelung eingeführt, die die MM und Shorties zwingen sollte, nach 3 tagen zu covern, also geliehene Shares glattzustellen. was dann bedeutet hätte, das bei fundamental guten werten und standfesten Shareholdern die Shorties und MM reichlich Aktien hätten kaufen müssen, um die geliehenen wieder glattzustellen. das hätte zu extrem steigenden Kursen führen können (ein sogenannter Short Squeeze), weil bei theoretisch über 3 Tagen geliehenen und short verkauften 10 Millionen Aktien auch die gleiche menge Aktien hätte gekauft werden müssen -und das in der Regel aus dem Ask, was eben für einen fetten Rebound gesorgt hätte.

Da die MM und Hedges aber nicht doof sind, passiert nach dem drei tagen folgendes: der MM, der mit z. b. 50.000 Aktien short ist und nach Ablauf der 3 tage eigentlich covern müsste, leiht sich diese 50.000 Aktien von einem anderen MM, der nun wiederum 3 tage zeit hat, der verliehenen 50.000 Aktien zu covern. was dann passiert? richtig, MM Nummer 2 findet MM Nummer 3, der ihm erneut 50.000 " leiht" . dieses spiel kann unendlich fortgeführt werden, es könnte sogar der erste MM wieder 50.000 Aktien der Nummer 3 leihen, weil ja MM Nummer 1 durch MM Nummer zwei gecovert wurde.

und so kommt es, dass es reichlich werte auf der SHO liste gibt, die dort seit Wochen (was ja eigentlich unmöglich ist)stehen und aus diesem miesen Kreislauf nicht herauskommen und weiter fallen oder stagnieren.

einen teil der Opfer findest du hier:

http://www.nasdaqtrader.com/aspx/regsho.aspx

ganz pervers wird es beim nächsten punkt:
beim naked shorten wird oft auf Margin Basis gehandelt, das bedeutet, dass wenn du z.b. 1000 Aktien gekauft hast, diese zwischen 4- und 10-fach beliehen werden. mit jedem kauf von 1000 Aktien löst du also mögliche Verkäufe von 4000-10.000 Aktien aus. auch hier wird das covern - wie oben besprochen- durch gegenseitiges beleihen ausgebremst.

bei derzeit rund 8500 börsenwerten in den USA und existierenden 9000 Hedges fonds kannst du davon ausgehen, dass jede noch so gesunde Firma Opfer werden kann. dadurch werden milliardenwerte vernichtet und Kleinanleger um ihr Geld betrogen. die meisten short Attacken werden über Kanada, Offshore und (man vermutet das) über Berlin gefahren.

erst wenn die sec das gegenseitige covern unter den MM restriktiv verbietet und dieses auch konsequent umsetzt und Verstösse drastisch bestraft, wird sich daran etwas ändern. Aber diese mafiöse Allianz von Hedges, MM und großen Brokerhäusern hat eben nicht nur Finanzpower sondern auch politische Macht. auf jeden fall ist es der größte Beschiss des Jahrhunderts und er wird ganz offensichtlich geduldet von den wichtigen Herren der weltweiten Finanzmafia.

bei der SHO List geht es darum, das berüchtigte Naked Short Selling einzudämmen. Gesellschaften, deren Aktien die folgenden 3 Kriterien erfüllen, kommen jeweils am Handelstag auf die THreshold (SHO List).

~ There are aggregate fails to deliver at a registered clearing agency of 10,000 shares or more per security;
~ The level of fails is equal to at least one-half of one percent of the issuer?s total shares outstanding; and
~ The security is included on a list published by a self-regulatory organization (SRO).

A security ceases to be a threshold security if it does not exceed the specified level of fails for five consecutive settlement days

D.h. bei ca. 360 Mio. ausstehenden SHRN Aktien sind mind. 0,5% = 1,8 Mio. Aktien geshortet, ohne geliefert worden zu sein, d.h. naked short. Das ist seit mind. 7 Tagen der Fall und deswegen steht SHRN seit 2 Tagen auf der Liste. M.W. greift die SEC ein, wenn ein Wert eine gewisse Zeit auf der Liste steht (meine 13 Tage).

SHO List heißt also erstmal, es wird gedrückt (von 11 Cent auf knapp 8 Cent in den letzten Tagen, ohne zu liefern, d.h. MM geben Verkäufe ein, haben aber die Aktien nicht. Meistens gibt es einen kleinen Hype, wenn die SEC-Frist abläuft. Es kann aber auch sein, dass die neulich bei RB gemeldete Registrierung von 3,5 Mio. SHRN Aktien der Eindeckung der Naked Shorts dient, d.h. die Aktien sozusagen vorher verkauft wurden.

beim kiten werden deine gekauften shares sofort verliehen und ins bid geworfen.

du kaufst 5000 aktien aus dem ask (grüner umsatz). das war ein verkauf eines anderen, der von dir erworben wurde.

wenn das z.b. 20x passiert, steigt der kurs, weil das ask leergekauft wird und kaum etwas ins bid fliegt.

shorts kiten gemeinsam mit den market makern.

das heisst: zusätzlich zu den eh schon shorten aktien (also die permanenten 200er, 500er ticks ins bid) verleihen die MM in der gleichen sekunden deine aktien, also die 5000 grünen stücken und werfen sie ins bid zurück.

nun sind bereits 2x 5000 aktien verkauft und 1x gekauft worden. der kurs kommt nicht hoch sondern wird mit diesen aktionen nach unten gedrückt, weil das ask normalerweise schwächer wird und das bid dann ebenso weiter abfällt.

auf dem weg nach unten wird eingesammelt (wenn erste blöcke entnervter fliegen) und stop losses eingesammelt (gestern war zb ein 34k block dabei).

anschliessend wir nach lust und laune entweder mit den billig abgegriffenen shares das geliehene volumen gecovert oder -was sie auch gerne machen (SHO liste): ein mm der 60.000 aktien short ist und nach 3 tagen ssettlen müsste,also covern, leiht sich einfach vom nächsten mm die 60k aktien, covert seine und ist durch damit. der andere market maker hat wieder 3 tage zeit und macht das gleiche nochmal.

so drehen sich also millionen geliehener aktien im market maker karussel und beeinflussen die kurse, obwohl es diese shares eigentlich nicht gibt.

einziges mittel wie erwähnt: schütze deine aktien, indem du einen verkaufsauftrag mit einem hohen verkaufspreis für deine aktie reinstellst, dann sind diese aktien zum beleihen gesperrt.

Nun weiß hoffentlich der Eine oder Andere wie es manchmal läuft

[GuHu1]

Antwort auf Beitrag Nr.: 35.185.212 von edelupolino am 19.09.08 11:48:32

hi ede,

da kann dir leider keiner helfen. gewinne mitnehmen, positionen stehen lassen, jeder tipp kann der falsche sein. aber du kennst ja das risiko.


jedenfalls bereitet sich dndn auf die möglichkeit einer zulassung vor.
offene stellen jetzt auf 21 erhöht.

[edelupolino]

Antwort auf Beitrag Nr.: 35.195.784 von GuHu1 am 20.09.08 13:27:02

Hi GuHu,
mich hat besonders die kursentwicklung vom 18. und 19.9. 08 beeindruckt; nachdem so lange darum gekämpft wurde, die $ 6,0 marke zu knacken, ging das ja plötzlich ganz rasant.
Dazu kommt dann noch die zahl der offenen stellen!

Die idee über NSS muss etwas relativiert werden: die Welt schrieb am heutigen samstag, dass noch recht wenig gegen diese betrugs-praxis getan wird. Zitat (S.17, Die Welt)

"In einem Verzweiflungsakt stoppte die SEC Leerverkäufe bei den Aktien von 799 Finanzinstituten..."

Hoffen wir das beste!

[edelupolino]

Antwort auf Beitrag Nr.: 35.199.096 von edelupolino am 20.09.08 21:12:10

Allerdings besagt dieser beitrag aus IV etwas völlig konträres zu dem "Welt"-artikel:

Did fridays trading consist of kited shares that were being covered in anticipation of todays SEC filing?
I noticed that on Friday the trading was tightly controlled and most of all the trades were going on the ask. I watch this stock on level 11 quotes on a daily basis and realized this was inconsistent with most trading days. I found this very strange. It appears the hedgies were given a heads up as they always do when any knew regs come into effect because it is clear to me now that kited shares were most likely being covered before the regs became effective. This new SEC regulation is what the market really needed to become more efficient and less corrupt. A companies share price was manipulatively contolled through the process of kiting shares. That is a process in which mms and hedgies sell naked shorts back and forth to one another until the 13th when they swap them with another fund thereby covering these shares before the go on the reg sho list. They could repeat this process indifinetly. By doing this they could manipulate the pps of stocks sending them in whichever direction they desired and of course mostly downward as they shorted these stocks while making fortunes. This new REG from the SEC is an attempt to eliminate this activity from occurring. This will provide a significant boost to DNDNs stock which most of us know is one of the most manipulated stocks on the exchange. My bet is we will see good news on Monday now that the ability to restrain the pps is marginal the forces that have achieved their desired results are likely very well positioned for the ride up.

IV, Author: rigtcall88, 9/20/2008

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.195.784 von GuHu1 am 20.09.08 13:27:02

Hab mir gerade die UBS Update Conference von Mr. Gold reingezogen, der klingt absolut überzeugt daß Provenge zugelassen wird, hab aufgestockt auf 2000 Stück!
Aber 50 % Risiko bleibt, hab schon oft verloren, mit GPC....
hoffentlich klappts mal mit Dendreon!
In einem Monat wissen wir mehr und die Prostatakrebskranken darf man doch nicht von Immunstimmulierungsaktionen die Ihnen helfen außen vorlassen, oder?

[edelupolino]

Antwort auf Beitrag Nr.: 35.225.514 von Magnetfeldfredy am 22.09.08 23:42:55

Hundertprozentige zustimmung, Fred!

Hilfe für die kranken ist das wichtigste -wenn dann rauskommt, was wir alle ahnen, lug und trug und absichtlich falsche gerüchte der betrugs-analysten, können wir nur hoffen, dass sich ein ankläger findet wie Spitzer (nur ohne eigene skandale), der ihnen den weg in den wohlverdienten KNAST weist.

Als zweites denken wir an unser geld und den erfolg der firma: das muss endlich mal klappen!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.230.360 von edelupolino am 23.09.08 10:13:15

Wäre wahrscheinlich zu schön um wahr zu werden.

Wenn Provenge keine Zulassung erhalten sollte, warum kann dann ein Prostatakrebskranker nicht selbst Provenge in der Apotheke kaufen sozusagen als nicht verschreibungsplichtiges aber apothekenpflichtes Produkt, damit wäre dem Kranken und Dendreon geholfen, oder?

[edelupolino]

Antwort auf Beitrag Nr.: 35.234.829 von Magnetfeldfredy am 23.09.08 14:59:47

das liegt an den (möglichen) gefahren, die von einigen medikamenten ausgehen:
z.b. fragen alle urologen, ob du eine herzkrankheit hast, bevor sie potenzmittel verschreiben.

Bei Provenge hieß es aber unisono "nicht schädlich für den patienten"!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.248.941 von edelupolino am 24.09.08 10:38:56

Dann wird Provenge auf Druck der Postatakrebskranken irgendwann zugelassen werden müssen, oder?

[edelupolino]

Antwort auf Beitrag Nr.: 35.252.025 von Magnetfeldfredy am 24.09.08 13:39:30

die kämpfen und haben sich auch gut organisiert, haben US-weite demos gemacht, aber gebracht hats bisher nichts:

vgl Investor Village

[GuHu1]

ok, seit gestern sind es 24 offene stellen bei dndn,die chancen liegen für mich weiterhin bei 50:50.

provenge frei verkäuflich durch apotheken ist quatsch, das ist doch kein nasenspray.
der wirkstoff wird aus dem blut...... des patienten gewonnen, etwas sehr einfach gesagt, schon das macht die idee absurd.

die proteste bzgl. der entscheidung im mai 07 bezogen sich auf die angenommenen COI der doktoren scher, flemming, hussain sowie der einfluss der drei auf die folgende fda entscheidung.

DAS IST NUR MEINE PERSÖNLICHE MEINUNG:
min. einer der \"lausejungs -mädels\" soll in konkurierende und mittlerweile gescheiterte konkurrenzwirkstoffe verwickelt gewesen sein.

[GuHu1]

Antwort auf Beitrag Nr.: 35.252.025 von Magnetfeldfredy am 24.09.08 13:39:30

hi fred,

nur wenn es wirkt!
dieses soll in der laufenden studie nachgewiesen werden.
die interimsdaten werden zum okt. errwartet, ob es zur frühzeitigen zulassung reicht werden wir sehen.

zweite chance ist 2009.

sollte die entscheidung ein jahr vertagt werden, behalte den folgenden kurseinbruch im hinterkopf!

risiko

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.262.343 von GuHu1 am 24.09.08 23:49:41

Servus,

Du hast Recht in der Apotheke gibts Provenge nie, aber ich hatte auch eine Arthrosebehandlung für mein Knie und dabei wurde mir auch mein Blut abgezapft um Leukozyten zu vermehren und die Entzündung zu stoppen, kann man doch vergleichen, oder?
Dafür brauchts auch keine FDA-Zulassung!
Ich bleib dabei und von 6 US Dollar gehts halt dann auf 3 US Dollar um dann 2009 auf 30 US Dollar zu steigen??

[edelupolino]

übrigens:
der dndn-kurs ging gerade bei Cortal C von 3,76 auf 3,91 hoch = sehr ungewöhnlich!

Ciao Ede

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.348.727 von edelupolino am 30.09.08 15:48:04

Der Oktober ist da, hoffentlich bringt er uns Denedreonen die erhofften Ergebnisse!

[edelupolino]

Antwort auf Beitrag Nr.: 35.358.474 von Magnetfeldfredy am 01.10.08 08:59:07

für den rest der aktionäre ist eines klar:
jetzt kommen Quartalszahlen (mäßig bis mies ) und AUSBLICK = extrem düster = der "bottom" ist wohl immer noch nicht da!

Für uns: hoffnung auf erfolg!!!

Ciao Ede

[bernie55]

BIO Commends SEC Efforts to Combat Illegal "Naked" Short Selling
Market Manipulation Especially Harmful to Biotech Companies

Last update: 12:30 p.m. EDT Sept. 30, 2008

WASHINGTON, Sep 30, 2008 (BUSINESS WIRE) -- The Biotechnology Industry Organization (BIO) today released its letter to SEC Chairman Christopher Cox and SEC Director Linda Thomsen commending the agency for its efforts to investigate fraud and crack down on activities such as rumor mongering and abusive naked short selling in capital markets.
"This type of illegal behavior is especially detrimental to emerging biotechnology companies whose value is so dependent on the results of their research and development efforts," said Alan Eisenberg, Executive Vice President for Emerging Companies and Business Development at BIO. "The peddling of false rumors regarding the results of clinical trials could substantially drive down a biotechnology company's stock price. Given the resource intensive nature of our industry and its dependency on capital markets, these illegal activities can be particularly damaging to our companies' efforts to gather investment."
Eisenberg also said that BIO "looks forward to working with the agency during the regulatory rulemaking process to ensure that securities of all public companies, including the biotechnology industry, are protected."
The vast majority of biotech companies are in the research and development phase of bringing medical therapies through clinical trials so that they can become available to patients. Because biotech innovations have an especially long and expensive road from the lab to the patient -- up to $1 billion over 10 years -- the current turmoil in global financial markets has rendered them especially vulnerable to failure.
BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

SOURCE: Biotechnology Industry Organization

http://www.marketwatch.com/news/story/bio-commends-sec-effor…

[GuHu1]

http://www.cnbc.com/id/26972681/site/14081545?__source=yahoo…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.386.258 von GuHu1 am 02.10.08 21:47:27

Was glaubst Du persönlich, sind die Daten gut genug für eine vorzeitige Zulassung oder müssen wir uns noch ein Jahr gedulden?

[GuHu1]

hi fredy,
wenn ich das wüßte.
ich hoffe natürlich auf die interimsdaten nicht mehr und nicht weniger, deshalb 50:50.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.403.147 von GuHu1 am 03.10.08 20:10:43

Genauso wie ich und tausende Prostatakrebskranke!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.403.147 von GuHu1 am 03.10.08 20:10:43

Na, der Feuerstein von TheStreet.com ist voll short auf Dendreon, weiß der mehr, jedoch auf der Homepage von DNDN sind jetzt schon 27 offene Stellen anstatt 24, wissen die mehr?
Ich bleib dabei!

[GuHu1]

Antwort auf Beitrag Nr.: 35.418.142 von Magnetfeldfredy am 05.10.08 08:29:12

hi fredy, wer weiß ?

anbei eine meinung aus dem IV.

http://www.investorvillage.com/smbd.asp?mb=971&mn=222342&pt=…

Re: Why wouldn't Gold know right now?-bobhouse

I just finished listening to the archived 9/17/08 UBS Conference.
I was particularly interested in this part:

After discussing that the integrated 9901 and 9902A trials had
225 patients and that there were 61 alive at the end of the
study, Dr. Gold said relative to the Interim:

"There were more than the 164 death events than seen in
the integrated analysis. We would expect to achieve the
prespecified criteria for stopping that study.

... In this situation, we believe the Interim is reasonably
powered to achieve its prespecified hurtle."

Now I think that management has learned a number of things
about the 9902B trial even though it is blinded. Whether it
relates to the CD54 or to the supplies of Provenge or for the
crossovers or whatever, they surely have some indicators of
how it has been going. As they mentioned they know the
number of deaths but not whether it was placebo or Provenge
patients.

They do have a detailed record of what occurred
in the 9901 and 9902A trials. Dr. Gold indicated that they
designed the trial to be comparable to the integrated trial's
results and they set up an Interim which, as Dr. Gold said,
should be successful if it follows 9901/9902A results.

Thus, with the initial trial design and statistical measures
that are known, the condition of the various patients when
they were accepted into the trial known, with certain indicators
along the way known, with the number of deaths known, and
with the statistical record of the previous trials expected to
be similar, one would think that management should have
a pretty good idea as to whether the Interim is positive.

Since the Interim is probably pretty sensitive re the
statistics where a small miss could mean the trial would
continue to the Final, there are no quarantees.

However, there are certain management activity
indicators that tells a bit more as to management's
confidence that the Interim will be positive as I
have recently posted- financial, jobs, new trials, etc.

On another point, Dr. Gold in the UBS conference stated that a
positive Interim would allow for DNDN to amend the BLA. He
didn't say anything about automatic FDA approval. How could
he when there are considerations regarding the trials and
the plant which will be reviewed by the FDA.

On the other hand, the LAST slide presentation was from
Schiffman's Rodman and Renshaw conference on 5/19/08.
There have been no other slide presentations available for
us to see after that, so we don't know if there have been any
changes to it or not.

Slide #12 of that conference read:

"FDA agreed that either a positive interim or final analysis for survival from
the Impact study would be sufficient for licensure of Provenge."

Now that slide's verbiage had to have been approved by Schiffman
who presented it. And it is hard to believe, as I stated before, that DNDN
would make a big issue out of being able to Amend their BLA with a
successful Interim or Final. Surely that would be one part of an agreement
with the FDA re the approvable letter discussions, given the rather
remarkable circumstances surrounding that letter vs the recommendation
for approval of the AC. However, I have to believe that Gold wanted to make
sure that such an occurance did not happen again and would press for some
assurance from the FDA that if the Interim or Final were found to be
statistically ok, the trial to have been properly done, and the plant inspected
and approved for commercial production, that DNDN would get "licensure".
And I think that is how that slide came to be presented with that language.

So, I think we have a number of indicators ourselves as to why management
is confident in a positive Interim. I also think that if the Interim is positive,
that Provenge will be approved. We will know very soon.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.426.269 von GuHu1 am 06.10.08 00:24:15

Servus GuHu 1,

Guten Morgen, danke für die Infos, sehr interresant, ich hoffe es steht 1:1 für Dendroen und Provenge!

Gruß Fredy

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.426.269 von GuHu1 am 06.10.08 00:24:15

Jetzt wirds spannend, die Interimsdaten kommen schnon heute:
Press Release Source: Dendreon Corporation


Dendreon to Hold a Conference Call Today at 9:00 AM ET to Provide an Update on Interim Results of Phase 3 PROVENGE IMPACT Trial
Monday October 6, 7:00 am ET


SEATTLE, Oct. 6 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) will host a conference call today, Monday, October 6, 2008 at 9:00 AM ET (6:00 AM PT) to review the outcome of the interim analysis of its IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE® (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer.

Those interested may access the call with the following information:
Time: 9:00 AM ET/6:00 AM PT
Date: October 6, 2008
Dial-in: 1-877-419-6598 (domestic) or [phone] (international)
Webcast: www.dendreon.com (homepage and investor relations section)


A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 888-203-1112 or 719-457- 0820 for international callers; the conference ID number is 5304314. The replay will be available from 2:00 pm ET on Monday, October 6, 2008 until midnight ET on Wednesday, October 8, 2008. In addition the webcast will be archived for on-demand listening for 30 days at http://www.dendreon.com.

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 is also developing an orally-available small molecule called Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters 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.




--------------------------------------------------------------------------------
Source: Dendreon Corporation

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.434.405 von Magnetfeldfredy am 06.10.08 13:29:27

Neue Homepage gibt`s auch noch, schaut super aus, www.dendreon.com!
Hoffentlich sind die Daten auch so gut!

[ipollit]

Antwort auf Beitrag Nr.: 35.434.405 von Magnetfeldfredy am 06.10.08 13:29:27

"the outcome of the interim analysis of its IMPACT..."

wenn es nicht nur um Sicherheit geht, sondern um Wirksamkeit, dann wird DNDN heute zerlegt werden... wird in diesem Markt allerdings vielleicht gar nicht groß auffallen...



mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 35.435.227 von ipollit am 06.10.08 14:18:07

die Daten kommen vor der Eröffnung...

rt...


mfg ipollit

[ipollit]

Antwort auf Beitrag Nr.: 35.435.451 von ipollit am 06.10.08 14:30:33

weder gut noch schlecht, soweit ich das im Moment beurteilen kann...

Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial

Monday October 6, 8:30 am ET
- Conference Call Scheduled for 9:00 AM ET Today -

SEATTLE, Oct. 6 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) announced today that it has completed the planned interim analysis of the Phase 3, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial designed to assess the safety and efficacy of the investigational active cellular immunotherapy PROVENGE® (sipuleucel-T) in men with metastatic androgen-independent prostate cancer. While Dendreon remains blinded to the data, the independent data monitoring committee (IDMC) reported to Dendreon a 20 percent reduction in the risk of death in the PROVENGE arm relative to placebo (Hazard Ratio= 0.80; 95% Confidence Interval [0.610-1.051]). The IDMC observed no safety concerns and recommended that the study continue to its final analysis.

"The treatment effect we have observed in this interim analysis is consistent with that observed in the integrated analysis of our previous Phase 3 trials in this patient population when analyzed at a similar 24-month follow-up time," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Given the delayed treatment effect we have seen in previous studies, we are pleased to see evidence suggesting a prolongation of survival in the PROVENGE arm at the time of the interim analysis, as well as a favorable safety profile."

At the final analysis, which is anticipated in the middle of 2009, if the study demonstrates approximately a 22 percent reduction in the risk of death, based on 304 events, the company would expect the study to meet its primary endpoint of overall survival.

"We look forward to the final results next year and the opportunity to make PROVENGE available to the many men with advanced prostate cancer who currently have few appealing treatment options," said Dr. Gold.

The IMPACT trial is a randomized, double-blind, placebo-controlled Phase 3 study which enrolled 512 men with metastatic, androgen-independent prostate cancer with a primary endpoint of overall survival. Following the U.S. Food and Drug Administration (FDA) Advisory Committee vote that there was substantial evidence of efficacy of PROVENGE and that PROVENGE was reasonably safe, the FDA requested additional clinical data to support the proposed efficacy claim. The FDA previously agreed that a positive final analysis for overall survival from the IMPACT trial would be sufficient to meet its request for additional clinical information to support the proposed efficacy claim for PROVENGE.

About Hazard Ratios

The hazard ratio is an estimate of the treatment effect in the treated versus the control group in a trial. The hazard ratio reported means that a PROVENGE patient who at the time of the interim analysis has 0.80 times the chance of dying compared to someone in the placebo group. Its reciprocal, 1.25, means a placebo patient has 1.25 times the chance of dying compared to someone in the PROVENGE group (this is the method that hazard ratios were reported in our previous trials).

About Active Cellular Immunotherapy with PROVENGE

PROVENGE may represent the first product in a new class of active cellular immunotherapies that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity.

mfg ipollit

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.435.562 von ipollit am 06.10.08 14:37:41

Gut auf alle Fälle für die behandelten Patienten, ob die Daten für die Börse gut genug sind wird sich zeigen, auch auf positive Überraschungen bei der Pressekonferenz bzgl. der Schmerzreduktion etc. sollte man achten, ist ja auch für die Betroffenen nicht unwichtig in welcher Lebensqualität man sich befindet, oder?

[Brisca]

???

06.10.2008 15:27
DNR: AUSSETZUNG/SUSPENSION
http://www.finanznachrichten.de/nachrichten-2008-10/artikel-…

[ipollit]

hält sich DNDN etwa an das Muster? ...



naja, eine seltsame Aktie...

mfg ipollit

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.436.970 von ipollit am 06.10.08 15:55:09

Hätte nichts dagegen und die Kranken auch nicht!!!

[Poppholz]

Antwort auf Beitrag Nr.: 35.437.086 von Magnetfeldfredy am 06.10.08 16:00:41

das hätte wohl niemand

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.437.779 von Poppholz am 06.10.08 16:33:58

Bin ja mal gespannt wie Dendreon heute schließt, alles ist möglich!

[LaPlue]

10 Dollar???????????? MOrgen 15 Dollar????

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.439.232 von LaPlue am 06.10.08 17:38:24

Alles ist möglich!

[LaPlue]

Antwort auf Beitrag Nr.: 35.439.291 von Magnetfeldfredy am 06.10.08 17:41:28

auch 100 Dollar???

[edelupolino]

Antwort auf Beitrag Nr.: 35.437.086 von Magnetfeldfredy am 06.10.08 16:00:41

...für viele ältere, die dazu noch mit anderen invests seit ca 1/2 - 1 jahr extrem verprügelt wurden (1 Freund von mir hat chinesische werte, die ein schatten ihrer selbst sind und hat sich nicht getraut, Dndn zu kaufen), wären gute ergebnisse vorwiegend begrüßenswert als ein weiterer weg der linderung/heilung dieser ultimaten krankheit:

geld lacht aber auch!

[edelupolino]

...ob Asshoff schon gecovert hat???

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.440.830 von edelupolino am 06.10.08 18:59:23

Die Frage ist wird zum Börsenschluß hin wieder abverkauft was ja nicht ohne Sinn wäre, denn die endgültigen Daten kommen ja erst Mitte 2009, oder?

[GuHu1]

jezt wirds lustig, da bin ich mal gespannt.

http://www.investorvillage.com/smbd.asp?mb=971&mn=223053&pt=…

FDA on the hook
Why is everyone letting the FDA off the hook. I assume that David Millers statement was correct and that many that previously did not believe the data (called "lousy' by some stock reporters/manipulators in the past) will now believe in the saftey and efficacy data based on what the IDMC reported. Does not the "many" include oncologists and urologists and scientists and researchers and even clinicians at the FDA?

The safety and efficacy has already been established and if not for the Dick Pazdur/Howard Scher shenanigans Provenge would have already been getting to the patients for some time now. Enough is enough....these are real people with real families.

Now, there is even more safety and efficay data. The FDA can reconsider with or without a new or amended BLA. Rememeber the bogus safety concerns announced by Scher? Someone stick a microphone in his face now.....

Theoretically, Dendreon could file a new/amended bla now if it wanted to. Also the FDA has the authority to reconsider anytime.

There is no reason the patients should be denied this treatment any longer.......real humane people, not computers, need to take action.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.442.115 von GuHu1 am 06.10.08 20:08:34

Denkst Du daß die FDA handelt, ich glaub die warten die endgültigen Daten 2009 ab, obwohl der Druck steigt und daß ist gut für Dendreon!

[LaPlue]

Antwort auf Beitrag Nr.: 35.441.129 von Magnetfeldfredy am 06.10.08 19:15:47

Bei -8% des DOW und NASDAQ ........ die Woche wird spannend!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.442.899 von LaPlue am 06.10.08 20:46:17

Das Marktumfeld wird sich bei "der Nachrichtenlage" kaum bessern, jetzt kommts auf die Anal-ysten drauf an was die wieder mal fürn "Scheiß" von sich geben!

[GuHu1]

Antwort auf Beitrag Nr.: 35.442.768 von Magnetfeldfredy am 06.10.08 20:38:46

kann mir schon vorstellen das -caretolive- wieder aktiver wird http://caretolive.com/ .

ob es was bringt, hmmmmm.

[GuHu1]

http://blogs.wsj.com/health/2008/10/06/dendreon-shares-climb…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.443.294 von GuHu1 am 06.10.08 21:03:30

Wie wird`s wohl weitergehen?

[edelupolino]

Antwort auf Beitrag Nr.: 35.456.913 von Magnetfeldfredy am 07.10.08 15:00:15

Wir sind offensichtlich wieder voll im griff der shorts, weil dndn ganz knapp am ziel vorbeigegangen ist: 20% höhere überlebensrate im "Provenge arm" gegenüber dem "Placebo-arm";
das reicht leider nicht für eine sofortige zulassung:
(hier: http://investor.dendreon.com/events.cfm?header=News)


...wobei noch zu fragen ist, wieso der Provenge-arm nicht in wirklichkeit 25% oder sogar 28% überlebensvorteil hat: wer weiß genau, um wieviel morbider/anfälliger (durch andere krankheiten) einige mitglieder des "Provenge arm" waren??? Hatten wir nur pech? Wussten andere mehr über den generellen gesundheitszustand aller probanden?Konnten sie deshalb so locker auf die ergebnisse warten??

Fragen über fragen

Im IV board haben einige unentwegte nachgekauft!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.463.866 von edelupolino am 07.10.08 20:54:12

Nur 2 % vom Endziel entfernt, ich gebe die Hoffnung für eine Zulassung 2009 nicht auf, schon im Hinblick auf die Kranken!
Warum hat Dendreon so viele offene Stellen wenn die vorzeitige Zulassung nicht klappt?

[edelupolino]

Antwort auf Beitrag Nr.: 35.464.268 von Magnetfeldfredy am 07.10.08 21:19:49

Ich meine, heut nachmittag gelesen zu haben, die stellen wären wieder gestrichen.
Schau mal auf der homepage nach!

Warten wir auf 2009!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.465.639 von edelupolino am 07.10.08 22:33:33

Du hast Recht von 27 auf 10 offene Stellen reduziert!

[GuHu1]

Antwort auf Beitrag Nr.: 35.465.639 von edelupolino am 07.10.08 22:33:33

von 27 sind noch 10 geblieben.
was nun?

1. provenge wirkt verglichen zu tax. (= placebo) mit 20% überlebensvorteil
2. nachweis konnte zu den interims nicht mit stat. sign. untermauert werden.
3. warten auf das trial ende mitte 2009 (war nicht vorher die rede von Q4 2009)

4. http://www.investorvillage.com/smbd.asp?mb=971&mn=223771&pt=…
Unfortunately, Provenge has the wrong pedigree. It doesn't emanate out of taxpayer funded initiatives originating in the National Cancer Institute nor does it enjoy the sponsorship of The Prostate Cancer Foundation. It certainly doesn't originate in the well funded laboratories of Big Pharma. It's not even associated with the prostate research efforts of The Department of Defense. In short, it's an embarrassment to all of the above for various reasons ranging from the pecuniary, the glory denied, the careers adversely impacted and the budgets that would be truncated.This is what is deemed important. Patients are just counters used to keep score.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.466.270 von GuHu1 am 07.10.08 23:20:04

Jetzt samma wida do wo ma herkemma san!

[GuHu1]

Antwort auf Beitrag Nr.: 35.479.153 von Magnetfeldfredy am 08.10.08 16:11:55

yep.

[GuHu1]

Antwort auf Beitrag Nr.: 35.466.270 von GuHu1 am 07.10.08 23:20:04

...... verglichen zu tax. (= placebo)

muss da wohl etwas vorsichtiger sein, placebo = standard of care, soweit mir bekannt ist, ist tax das einzig zugelassene medikament bei late stage prostata treadment. deshalb hab ich tax = placebo geschrieben was aber nicht zu 100% so sein muss!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.484.626 von GuHu1 am 08.10.08 21:06:51

Also, daß hört sich für Dendreon schon wieder besser an, könnte die FDA nicht Dendreon kontaktieren und aufgrund der guten Daten doch noch vorzeitig zulassen, hat`s so was schon mal im Sinne der Patienten gegeben?

[GuHu1]

Antwort auf Beitrag Nr.: 35.485.747 von Magnetfeldfredy am 08.10.08 22:27:14

gut wären die daten wenn sie statistisch signifikant wären, sind sie aber nicht!
wieso hört sich das besser an, ich habe meine vorherige aussage relativiert.
wie die fda, was, wann, wie, entscheidet und auf welcher grundlage ist spekulation.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.486.285 von GuHu1 am 08.10.08 23:25:32

Bist Du noch dabei, ich schon!

[GuHu1]

Antwort auf Beitrag Nr.: 35.491.184 von Magnetfeldfredy am 09.10.08 10:14:40

ja, aber glaub mir, hätte ich gekonnt wäre ich raus. :O
jetzt schau ich mal wie es sich entwickelt.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.505.043 von GuHu1 am 09.10.08 22:59:30

Was heißt daß "hätte ich gekonnt, wäre ich raus?
Jetzt müssen wir halt notfalls bin Mitte 2009 warten, wenns zu dieser Zeit noch Aktien gibt!

[GuHu1]

Antwort auf Beitrag Nr.: 35.515.138 von Magnetfeldfredy am 10.10.08 13:38:13

so nun ist mit cege der letzte potentielle konkurrent zu dndn`s provenge ins straucheln geraten ( inwieweit das straucheln folgen hat wird sich zeigen).

posting vom 27.08.08, aus dem straucheln ist eine satte bauchlandung geworden.

http://biz.yahoo.com/bw/081016/20081016005394.html?.v=1

auszug aus dem AC, Dr. Scher:

"So I say well, what if we think that this (Provenge) really should be available, start thinking about the number of agents (Asentar and GVAX) that are currently under development."

nun Dr. Scher, wo sind die "agents", wo sind sie?

[GuHu1]

wie scharfsinnig hier von Joe Pantginis' argumentiert wird verblüfft mich ein ums andere mal.

http://www.cnbc.com/id/27216583/site/14081545?__source=yahoo…

Dendreon Gets Another Analyst "Down"
Posted By:Mike Huckman
Topics:Stock Market | Corporate News | Pharmaceuticals
Sectors:Health Care Equipment and Services | Health Care | Pharmaceuticals
Companiesendreon Corp

I know I blogged as recently as last week that I thought there wouldn't be much reason to write about Dendreon for awhile, but I couldn't help myself when I got an email last night from Merriman Curhan Ford, which is launching coverage of DNDN with a "Sell" rating.

And I am doing so at my own peril since I know I'm gonna take it on the chin from the Dendreonians for even calling attention to an analyst's bearish position on the stock.

Baby biotechs like Dendreon [DNDN 4.97 0.06 (+1.22%) ]typically get little, if any, analyst coverage so on that level alone you could argue it's worth at least this brief mention.

The analyst, Joe Pantginis, is initiating coverage of a handful of biotechs, but DNDN is the only one in the bunch that he's telling risk-averse investors to stay away from. In the research note to clients titled, "All Dressed Up with Nowhere to Go," he writes, "We believe the stock has been too emotionally charged from both an investor and political standpoint and we would avoid the shares at this time."

Pantginis has several reasons for his recommendation including potential competition for DNDN's prostate cancer drug Provenge (should it ever make it to market) that will limit its sales potential, the price of the treatment (he throws out the "common estimate" of $75,000 for the three infusions) and his belief that Dendreon will have a difficult time attracting a corporate partner to sell the drug outside the U.S.

Update: Part of Joe Pantginis' thesis on Dendreon is that a prostate cancer drug called GVAX from Cell Genesys would be better and cheaper than Provenge. But this morning CEGE announced it's abandoning the late-stage clinical trial of that treatment because it had such a small chance of success.

But the lynchpin of his argument is the final Provenge test results that the company says are due out around the middle of next year. "If the...data does not replicate the earlier debatable 'survival' data, we would expect the stock to be down 60-70 percent (on the first trading day following the release of the results," Pantginis writes. But on the flip side he places 50-50 odds on the clinical trial being a success. "We believe a positive...outcome could significantly drive the stock forward. (But) we believe this singular event does not warrant owning the shares (except for very short-term oriented investors who want to bear the risk)."

Credit Cards Could Become Next Trouble Spot in Crisis
Questions? Comments? [e-mail]

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.595.674 von GuHu1 am 16.10.08 20:38:14

So sind Sie halt die "Anal-ysten"!

[GuHu1]

Antwort auf Beitrag Nr.: 35.599.254 von Magnetfeldfredy am 17.10.08 07:38:53

geliehen von birgit aus dem ELAN thread:

Der prominente Fred Barron hat Tysabri bekommen obwohl es für seine Krankheit nicht zugelassen ist--tja--mit den richtigen Kontakten ist so Einiges möglich...

Dallas lawyer Fred Baron allowed to use experimental drug in cancer fight

06:25 PM CDT on Thursday, October 16, 2008

By JEFFREY WEISS / The Dallas Morning News
[e-mail]

Dallas lawyer and Democratic Party fundraiser Fred Baron has won his fight to gain access to an experimental cancer drug, according to an e-mail sent out by his son late Thursday afternoon.

According to the e-mail from Andrew Baron, his father was given the drug, called Tysabri, in hopes that it would reverse what doctors say is an otherwise incurable case of multiple myeloma, a cancer of the bone marrow.

Tysabri has been approved to treat multiple sclerosis and Crohn’s disease but not cancer. Researchers began preliminary clinical trials testing the drug on patients with multiple myeloma only six weeks ago and don’t yet know whether it works.

The drug is not available to other cancer patients without the permission of the manufacturer, Biogen Idec. As of Wednesday night, the company was refusing to give that permission. A Biogen spokeswoman said that allowing Mr. Baron to use the drug could jeopardize its use by thousands of other people.
Also Online

Link: Son\'s plea to drug company

But Mr. Baron’s family enlisted some of their well-known friends to lobby the company. The list included Lance Armstrong, the bicyclist and cancer survivor; Bill and Hillary Rodham Clinton; Sen. John Kerry, D-Mass; and Sen. Edward Kennedy, D-Mass., who has brain cancer.

Andrew Baron, founder of the Web video company Rocketboom, posted a letter with details of his father’s condition on his personal blog. His plea that his father be allowed to get Tysabri was picked up by the online technology community, which posted links on several other well-known blogs.

Andrew Baron sent out a brief note late Thursday afternoon:

“Thanks to the persistence and hard work of so many friends, Frederick has received Tysabri. The Mayo Clinic working with the FDA found a legal basis for this use. We have every expectation of a positive result.”

Access to the drug was not granted by Biogen, a company spokeswoman said.

“The FDA did notify us late yesterday they were working directly with the Mayo Clinic to try and resolve the situation,” Naomi Aoki said. “It wasn’t through us.”

Mayo Clinic officials declined to comment.

Neither members of the Baron family nor representatives of the FDA were available to provide additional details about how Mr. Baron obtained the drug.

Most prescription medications can be used for “off-label” treatments without additional approval. But Tysabri was pulled from the market once because of its connection to a rare brain infection, and any off-label use must be approved by Biogen.

Biogen officials said they feared that if Mr. Baron had bad side effects from the drug, the company would have difficulty getting approval for its use by other cancer patients. It also feared that doctors would become reluctant to prescribe the drug for MS and Crohn’s.

In his letter, Andrew Baron said that Dr. Andrew von Eschenbach, head of the Food and Drug Administration, had given “special approval” for his father to get the drug. His letter also said that the FDA had agreed “that there would be no legal risk and no negative consequences” to Biogen if something went wrong.

An FDA spokesman said Biogen’s president had called Dr. Eschenbach but that no such immunity had been given to the company.

“FDA has provided no such assurance to the company,” Christopher DiFrancesco said in an e-mail. “We recognize and appreciate that expanded access programs involve less-controlled use of experimental treatments than the well-controlled environment of a clinical trial, and thus we would consider information that might be obtained in this instance within that context.”
__________________________________

bitte????????
eine therapie (provenge) welche 20% überlebensvorteil gegenüber dem standard of care ( i.R. tax) bietet, aktuell nachgewiesen u.a. durch die interimsdaten 9902b am 06.10.08, bleibt dem durchschnittlichem volk verwehrt!
ja ja ich weiß, stat. sig. ist die studie erst bei 22%.

ich meine, all die hochgepriesenen \"agents\" sind gnadenlos gescheitert, entweder waren sie tödlich oder wirkungslos oder beides und das stand vor beendigung der phase3 studien fest!

[GuHu1]

http://www.investorvillage.com/mbthread.asp?mb=971&tid=59135…

Interim CC Oct 6 transcript

This is Jennifer Williams and we are happy you could join us today for our conference call. Joining me are Mitch Gold, Jon Schiffman, David Urdal and Mark Froelich. (disclaimer stuff)…turn over to Dr. Gold:

Gold: Thanks Jennifer…First let me remind you of the design of this study. The IMPACT study is a randomized, double blind, placebo controlled phase 3 study that enrolled 512 men with metastatic, androgen independent prostate cancer.

The primary endpoint of the trial is overall survival. The statistical plan was designed using the integrated results of two previous Phase 3 studies, 9901 and 9902a. The interim analysis was performed by an independent data monitoring committee, or IDMC. The IDMC reported no safety concerns and recommended that the study continue to its final analysis. While we remain blinded to the data, the committee reported to Dendreon a 20% reduction in the risk of death in the Provenge arm relative to placebo, a hazard ratio of .80. Alternatively the hazard ratio can be expressed as 1.25, representing a 25% increase in the risk of death in the placebo arm relative to the Provenge arm. At the final analysis, which is anticipated in the middle of 2009, if the study demonstrates an approximately 22% reduction in the risk of death, based on 304 events, the company would expect the study to meet its primary endpoint of overall survival.

While we would have liked to have received results that would have allowed us to amend our BLA at this time, as we said before, the final analysis is designed for a higher probability of success. Here are a few key considerations as we look forward to the final analysis from IMPACT. At the time of the data cutoff for the interim analysis, which occurred in May of this year, the median follow up time in the IMPACT study was approximately 24 months. As we reported today, we observed a 20% reduction in the risk of death in the Provenge arm with a hazard ratio of .80. Now if we look at the integrated analyses of results from 9901 and 9902a at a similar follow up time of 24 months, we observed a 22% reduction in the risk of death, a hazard ratio of .78. Therefore, these results are consistent with those from our previous completed Phase 3 studies of Provenge in this patient population at a similar follow up time.

As you may recall, the final analysis from our integrated studies showed an approximately 33% reduction in the risk of death, a hazard ratio of .67, supporting the hypothesis that there is a delayed treatment effect of Provenge, which tends to get larger over time. Given that the results reported today are consistent with those from our previous integrated analyses, at a similar follow up time, we are looking forward to the final analysis of the IMPACT study next year.

Prostate cancer is, without question, a difficult disease to treat, with only one product in the past 20 years that has been approved by the FDA that has shown an improvement in overall survival. Before we conclude, I would like to thank the hundreds of men who have participated in the IMPACT study. In the 10+ years that Provenge has been under study for the treatment of advanced prostate cancer, more than 800 men have participated in the clinical studies. These men have demonstrated courage in their participation in our clinical trials, and have contributed to what we hope will be an advancement in medical care for prostate cancer patients. At this time I’ll turn it over to Q and A:

Mark Monane, Needham and Co.: Thank you for reviewing the results with us…the hazard ratio that you reported, is that an adjusted log rank analysis? I remember you talked about adjusting for certain factors and maybe you could go over those factors and answer that question first.

Gold: I’ll let Mark take that one.

Froelich: The analysis was an adjusted Cox model in which we adjust for the prognostic factors PSA and LDH

Monane: OK, that was helpful. And then in the follow up, I guess the question is, in the final analysis will the patients still alive will continue to contribute data points in the trial, patients that are dead will not, but the question is, in the trial recruitment, the patients that were recruited later in this trial study, can you tell me whether these patients were similar to those recruited earlier in the study? Is there any reason to believe those patients would be different?

Gold: What we’ve said in the past, and what we know is that we’ve conducted a Halabi analysis on the total patient population from the IMPACT study and compared to that from 9901 and 9902a and we see that the patient population is very similar to that what we saw in 9901 as well as the integrated analyses. So the Halabi model shows that the baseline characteristics are consistent with what we’ve seen in our other studies.

Monane: When you say with the 22% reduction in risk you’re talking about a Hazard Ratio of .78, is that how we should interpret it?

Gold: That is correct.

Monane: …and at that point when you say meet the primary endpoint outcome you’re saying that that p value would be less than .05 with a Hazard Ratio not eclipsing 1?

Gold: …um, would meet the pre-specified level of fiscal analysis plan for the final analysis…yes.

Monane: OK. Then we can assume that today the date that you reported today did not meet that endpoint…is that a fair assumption?

Gold: Correct. It did not meet the pre-specified criteria to allow us to amend our BLA. That being said what we can take away from the data that we received on the interim analysis is that it is very consistent with what we saw on the integrated analyses of 9901 and 9902a and that both studies have shown an increased benefit over time. I guess another caveat to that is that not only in the integrated analysis but in 9901 and 9902a we saw the treatment effect increase over time.

Monane: Have any patients been lost to follow up…do you have data points on all of the patients going forward?

Gold: Right now its difficult for us to say but there’s been very few patients lost to follow up…it’s not 100% as it was in 9901 but its very close.

Monane: I’ll get back in the queue…thanks for the added information.

Joel Sendek, Lazard Capital Markets: Can you tell us what the P value was at the interim analysis.

Gold: As we said in the past, we keep the details of the fiscal analysis plan and we look at that as proprietary to the company, but what I can tell you is that the final number of events is 304 events, and we’ve preserved a substantial amount of alpha for the final analysis.

Sendek: That was my second question…which is…what is that?

Gold: Let me just emphasize, as Mark just mentioned, the company did not receive a p value from the IDMC for the interim analysis.

Sendek: Can you tell us what the alpha spend is at this point so we’ll know what you’ll need at the final analysis?

Gold: What I can say is that we’ve preserved a substantial amount of the alpha for the final.

Sendek: In the answer to Mark’s question you said that you’d need a .05, so I’d presume that number would be less than .05, right?

Gold: Mark said .05…we never said .05. I think the best way to look at it Joel is to look at the stats, so if we say we need a 22% reduction in risk of death in the final analysis then we would expect to achieve the statistical hurdle.

Sendek: Presumably what you are saying this morning is that you just missed it. If the interim were .78 as opposed to .80 you would have stopped the trial?

Gold: All I can tell you is that we did not meet the pre-specified criteria for stopping and amending our BLA but I see going forward we need a 22% reduction. We’re at 20% today and, historically we’ve seen an increase in the treatment effect over time in our clinical studies so we’re looking forward to the analysis that we’re going to receive next year.

Sendek: Just one more…so if it’s in line with what you thought but you missed the interim, I’m wondering, did you make a mistake when you came up with your interim statistical analysis plan, you know, because there’s a disconnect there in my mind and I’m wondering if you could explain.

Froelich: The study was powered on the final results of the integrated results of 01 and 02a, which was a risk reduction of 33% so the interim result has less power than the final analysis by design so we still feel reasonably comfortable with our projections for the final analysis

Sendek: Thank you.

David Miller, Biotech Stock Research: The interim would have had to have a much lower hazard ratio than .22 to be successful, correct?

Gold: Much is a descriptive term…

Miller: Would have to have a lower than…

Gold: It would have had to have had a lower hazard ratio than we observed today for us to meet the pre-specified criteria for stopping…

Miller: Right, but you said you have to have a 22% risk of death or a .78 Hazard Ratio, that will be sufficient to get success at the final analysis, correct:

Gold: That is correct. Two things to take into consideration. One is the treatment effect, the other is the increased number of events.

Miller: But if you had shown that .78 Hazard Ratio today because of p value spend and things like that that have to do with the interim it would have not have been successful.

Gold: We have not talked about that specifically, i.e. what would we have needed at the interim to be successful but I think we wanted to give, going forward, that if we have a 20% reduction of risk today, and based on how much alpha we’ve preserved for the final we need to meet a 22% reduction of the risk of death.

Miller: I’m going to move on to something else then. Can any of the patients on the control arm roll over now or are they all past that point?

Gold: The patients that are in the control arm can still roll over if they want and the roll over rate to the frozen version of Provenge has been consistent with what we’ve seen in the previous Phase 3 studies.

Miller: The first number of patients into the trial had a lower Gleason score by trial enrollment and you have said that in our previous trials, the previous trials, that the Hazard Ratio improved, can you talk a little bit about how you would respond to the question or to a charge that this data kind of shows the healthier patients, the patients later on the trial, by definition, by Gleason score, were sicker, therefore its unlikely that they would see the same improvement as the trial goes forward.

Gold: What I would emphasize, first off, is that the patient population as a whole in IMPACT is based on Halabi and is very similar to what we saw in 9901. And 2nd what I would point you to…I know you’re familiar with this poster, this poster that Dr. Aaron Small presented at the ASCO Prostate Cancer meeting a couple years back, we showed that biggest percentage differences in survival were in patients with the highest with the highest Gleason scores. So the take home message is that the survival benefit that we’re seeing is independent of Gleason score.

Miller: My last question is…given that there is this clear tail effect, and that the data looks better going forward, the longer out you go, are you worried or do you have any second thoughts about moving that final analysis forward?

Froelich: The final analysis is pre-specified under the protocol to happen at 304 events so we can’t change that at this time but as I noted before we comfortable that the trial was
adequately powered for an overall reduction of 31% which is consistent with what we saw in our prior trials and integrated analysis.

Gold: And David what I’d like to emphasize is, I don’t know if you picked it up in my prepared comments, the data cutoff date for the interim actually occurred in May of this year…

Miller: Yeah, I did pick that up.

Gold: So…

Miller: You guys made an amendment that essentially accelerate that final analysis from sometime in 2010 to I assume it’s still second half of 2009…are we still 2nd half of next year for the final?

Gold: We said middle of next year…

Miller: OK, middle. So you accelerated that from 2010. Given that there is this tail effect are you having 2nd thoughts about doing that?

Gold: No, because I think what we see is that a 20% reduction of risk of death today with a median follow up of 24 months is very similar to what we saw in the previous Phase 3 studies and if that occurred in May and the final is going to occur sometime in the middle then I think we’re pretty comfortable with the…if the treatment effect repeats itself and it tends to increase over time in effect as it did in 9901 and 9902a and the integrated analysis then I think we’re comfortable with that.

Miller: I guess I do have a final question. I just want to make sure that I understood the answer to Mark’s first question…this is the adjusted Cox hazard ratio?
Gold: Correct.

Miller: OK. Thanks. I’ll jump back in queue.

Gold: David? The last thing is that when we gave you the .78 number at 24 months for the integrated analysis that was also on an adjusted Cox basis as well.

Miller: OK, perfect, thank you.

William Ho, BOA: Could you discuss the recent failures of some of the other companies in the area of immunotherapy and what perhaps makes you different and increases you confidence in success next year.

Gold: Without getting into specifics, in general, prostate cancer has been a very difficult disease to treat and we’ve several studies out of late that have shown a negative treatment effect on overall survival. We’re very encouraged by the results that we’ve seen today in the interim analysis showing a 20% reduction in the risk of death. I can’t speculate as to why those studies have failed and we’ve seen the data that we’ve seen today, but I think there are some inherent differences that I should highlight. First, we use a recombinant protein as our antigen delivery cassette, and that recombinant protein technology I do think is a key piece of why we are able to generate a substantial immune response against the antigen delivery cassette. Second, we use an ex-vivo process to load up the dendritic cells and as a result we take it out of the immunosuppressive environment that exists in vivo, within the cancer patient, and are able to activate the dendritic cells and we give a very large number of active antigen presenting cells that comes back to the patient. So I think there’s probably a whole host of factors that may be contributing. I don’t think there is anything that we can conclude right now but I think we’re encourage by the results that we’ve seen today, particularly in light of the results that we’ve seen come out over the last year or so.

Ren Benjamin, Rodman: Can you let me know if a futility analysis was part of this interim analysis, and if so, what would have been required to stop the trial because of futility?

Gold: As we’ve said in the past there was no futility analysis as part of this interim analysis.

Benjamin: The hazard ratios that were reported…was in a different manner than it was presented in the past…was there a reason why there was a switch here?

Gold: There is a lot of debate in scientific literature about what is the best way to report these hazard ratios. The way that we reported it today is one that is becoming an increasing trend in the lit. and we felt it was important to go to that trend as we look forward to publishing this data and having it consistent with what the community is seeing.

Benjamin: Based on the rate that you’re seeing right now is there any chance that your final analysis comes in even earlier than what you’re predicting now?

Gold: As we said in our prepared comments we’re comfortable with projecting out to the middle of 2009.

Aaron Reems, Wachovia: Could you provide us with the confidence interval for the 24 month hazard ratio that you provided us at .78.

Gold: I don’t have than right now Aaron.

Reems: OK. With data cutoff coming in May can you walk us through what needed to occur between data cutoff and now, and was it expected to take 5 months to gather that data for the review or were there other things that were affecting things for the Data Safety and Monitoring Board getting together to review that data?

Froelich: Just to clarify, we had to clear the entire data base, not just the survival but all the safety and other info needed to file a BLA should the interim have been positive. That’s the amount of time, with more than 80 clinical sites, to bring all the data in, clean it, and lock the data base.

Monane: In the previous data set we saw some long survivors…a certain percentage of patients were alive 3 years later…can you tell us anything about that with the new data set?

Gold: No. We’re blinded to the data Mark so we have no additional data on, for example, the shape of the curves or long term survivors, etc.

Monane: How about the standard deviation of the trial? Obviously that’s going to be an important statistical analysis. Can you describe that or tell us if that was consistent with what you saw in the previous 9901 analysis?

Gold: Mark, everything that we received from the IDMC is included in the press release today.

Monane: The company published some information about the role of a booster shot and the utility a trial you did in some Provenge patients. Can you talk about that a little more and did any patients get an opportunity to get a booster? I know it would probably be a frozen booster. Was that opportunity given?

Gold: The boosting data that we’ve shown is in the P-11 trial and that is in an earlier stage prostate cancer population. No patients in 9901, 9902a or IMPACT have been eligible for a booster. But we’re happy to talk about the concept of boosting if you’d like.

Monane: So no patients in this trial got a booster, correct:

Gold: Correct.

Monane: Did the company have any expectations of this analysis? Are you happy with this analysis? Disappointed? What have you really learned from this analysis in terms of Provenge development going forward and thinking about it as part of the company?

Gold: We’re encouraged by the data that we received by the IDMC. Consistency and reproducibility are one of the hallmarks of biological activity of any product, and the ability to impact survival, particularly in a disease like late stage prostate cancer, is potentially very meaningful. So the fact that we’re seeing data today—20% reduction in the risk of death—that’s very consistent with what we’ve seen in our previous Phase 3 trials and very encouraging to the company. As Greg and I have said when we meet with the investment community we always position the interim analysis as an opportunity to accelerate the regulatory pathway but that the final analysis, by design, has a higher probability of success. The fact that we shot a 20% reduction in risk today and that target we are shooting for in the middle of next year is a 22% reduction and that in our previous Phase 3 studies we’ve seen this increasing treatment effect over time, I think we’re looking forward to the results of the IMPACT study next year.

Miller: Do you assume that there would be a faster clean of the data next time or would it be back to the five months that it was this time?

Gold: I don’t think we can speculate on that. Mark’s team did a tremendous amount of work to get ready for this interim analysis and he had to do a tremendous amount of cleaning of the data to get it ready for the IDMC so I think it’s difficult to speculate on how long it will take…we’ll do it as rapidly as possible.

Miller: You wouldn’t have to repeat this on the patients that have died already?

Froelich: That’s correct.

Miller: Are you going to meet with the FDA on these data?

Froelich: This data has already been discussed with the FDA.

Miller: Anything you can characterize from their comments on it?

Gold: There really isn’t anything meaningful to discuss other than that we’re encouraged by the data and we didn’t meet the pre-specified criteria to be able to render an amendment to the BLA and we look forward to the final data.

We look forward to the final results of the IMPACT study in the middle of next year. In the meantime, we’ll continue to update you on our latest Phase 2 trials of Provenge and the other products in our pipeline that we’re excited about. Thanks for participating in the call and have a great day.

[hakur]

Auch in der schwärzesten Nacht gibt es Hoffnung.

Nach längerer Abstinenz , es gab charttechnisch nicht viel zu melden, hier ein Update.
Es bildete sich in den letzten Wochen ein fallender Keil heraus, kein lupenreiner aber immerhin besteht die Chance auf Kurse in Richtung Norden. Vielleicht müssen sich die geliebten Shorts eindecken, wie schon erlebt am 6.10.08 , war ein klarer Shortsqueeze
Blöderweise war ich unterwegs Der Frust saß um so tiefer

Der Keil könnte sich in 1-2 Tagen auflösen.
Soll kein Hinweis zum Kauf oder Verkauf sein, just eine Info.

so loong,
wie sagt Guhu immer DHSZ, schönes Wochenende

[GuHu1]

Antwort auf Beitrag Nr.: 35.697.966 von hakur am 25.10.08 15:12:19

hi hakur,

ja den spike am 06.10 hätte ich auch gern genutzt.
hoch raus niedrig wieder rein aber so ist das leben.

DHSZ, yep!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.702.535 von GuHu1 am 26.10.08 20:55:43

News:

Dendreon hat nicht nur Provenge sondern auch Neuvenge zu bieten, beides basiert auf Immunstimmulans, hoffentlich stimulierts auch den Kurs!
Dendreon Presents Integrated Analysis of Clinical Data from NEUVENGE Trials at Chemotherapy Foundation Symposium
Thursday November 6, 7:30 am ET


SEATTLE, Nov. 6 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today will present a summary of Phase 1 clinical data of NEUVENGE(TM) (lapuleucel-T), an investigational active cellular immunotherapy, at the Chemotherapy Foundation Symposium in New York City. The presentation, which integrates the data from two clinical trials, highlights the safety profile, immune response and clinical activity of NEUVENGE in patients with HER2/neu-positive cancer who have failed standard therapy.
ADVERTISEMENT


"We are encouraged by the significant immune responses generated to NEUVENGE in these trials, which included patients with advanced breast, ovarian and colon cancer," said John W. Park, M.D., associate clinical professor of medicine and neurosurgery at the University of California, San Francisco. "The therapy was well tolerated and demonstrated evidence of clinical activity, with several patients experiencing prolonged periods of disease stabilization following treatment. These findings warrant further study of this promising immunotherapy."

The two Phase 1 studies (D2000-1 and D2000-2) were designed to evaluate the safety and immunologic activity of NEUVENGE in patients with metastatic HER2/neu-expressing cancer who had evidence of progressive disease following standard therapies. Patients underwent three infusions of NEUVENGE over an approximately one month period. Patients who achieved a partial response, or had stable disease lasting through Week 48, were eligible for re-treatment with a booster, using the same protocol and dose as the initial treatment.

A total of 37 patients were treated. Results from the integrated analysis showed that treatment with NEUVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fatigue, fever and chills. The median T cell proliferative stimulation index in response to the immunizing antigen increased from 1.3 at baseline to 19.7 at Week 4 (p = 0.0002), 19.4 at Week 8 (p < 0.0001) and 20.7 at Week 16 (p = 0.02). Immune monitoring performed in three of four patients who underwent repeat treatment suggested an increase in immune response following the booster treatments. Five patients had prolonged disease stabilization ranging from 48 to 94 weeks, without the addition of other cancer therapy other than the continuation of bisphosphonates. In addition, one patient experienced a partial response lasting approximately six months.

"We were pleased to see consistent results across both NEUVENGE trials, particularly as they further substantiate the tolerability of this therapeutic approach," stated Mark Frohlich, M.D., senior vice president, clinical affairs and chief medical officer. "These data provide further evidence of the promise of our active cellular immunotherapy platform which also includes PROVENGE® (sipuleucel-T), our lead product candidate currently in late-stage development for prostate cancer. We expect to receive the final data analysis from our ongoing Phase 3 PROVENGE trial in mid-2009 and look forward to discussing further clinical development plans for NEUVENGE and our immunotherapy pipeline after that time."

About NEUVENGE

NEUVENGE (lapuleucel-T) is an investigational product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. ACIs hold promise because they may provide patients with a meaningful clinical benefit with low toxicities. NEUVENGE is designed to stimulate cellular immune responses against HER2/neu. HER2/neu is over-expressed in a variety of solid tumors, including breast, colorectal, bladder and ovarian cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

[GuHu1]

Antwort auf Beitrag Nr.: 35.856.518 von Magnetfeldfredy am 06.11.08 17:26:05

hi fredy,

ja nett, aber das augenmerk liegt auf provenge.
ich hoffe die beschleunigung des trials ( von 360 auf 304 events ) war kein fehler. :rolleyes

[GuHu1]

user moonshooter:

A few notes from the webcast...
I revisited the webcast from this morning and transcribed a couple of notes I thought might be of interest. The comments begin at the 17:45 minute mark and include some of Schiffman's closing remarks during his discussion of financing.
=====

"bought large amount of raw material this year associated with the pre-approval inspection process and have had very substantial levels of clinical activity."

(I'm not quite sure what he meant by the latter part of that sentence. Maybe someone could clarify for us.)

"we believe we are very well positioned to be the first to market active immunotherapy with a large potential market.
...The data does support a significant survival benefit with a favorable safety profiel. We've seen very strong physician and patient interest in these types of therapies that's been expressed since the Advisory Panel..."
------------------------

Not transcribed above were Schiffman's comments to the effect they have sufficient cash and expecting the final in mid year in 09, he actually expects a reduction in cash burn. He reitereated they hold 100% of WW rights, but indicated they would seek an overseas partner.

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=231881&pt=…

Messed up rules!
As David Miller once said: “Provenge works, I’m just not certain it will ever be proven to the extent the FDA is requiring”.

Provenge has already proven that it is safe and effective, even before any IMPACT results were known.
I believe that when they hit 20% at interim that Dendreon believed it was good enough and that the FDA would either: 1) allow immediate amendment to the BLA based on the report, or 2) allow the remainder of the trial to be unblinded to a certain extent, or 3) allow an additional free look. Dendreon and the IDMC likely thought that the FDA would/should act humanely. However NOT showing humanity is the one consistent thing the FDA does.

I believe this irritation with the FDA by Dendreon came through in the first communications from Mitch Gold following their meeting with those at the FDA.

It is a travesty that the evidence to date is not enough for a proper risk/benefit analysis to be performed by the FDA when it comes to a late stage disease with no good treatment options.
Since the IMPACT results are supportive of the combined trials in that the results are consistent and there was 20% additional survival, what the hell are we waiting for?

The arbitrary selection by the FDA that 22% would be the number that to them would be statistically significant is one thing but to completely ignore the IDMC reported IMPACT results on yet another near miss to the level imposed upon it by the FDA, defies reason and common sense.
Not only do I think that Provenge will easily blow by the 22% needed at final I believe they probably already have surpassed it and I think the IDMC release of the 20% number is because they also looked at the results and thought them somewhat incredible (but their hands were tied by the 22% agreement). They then thought it worthy, based on what they were seeing, to take the very unusual step to take it to the FDA, after some discussion with Dendreon.

The FDA said “no, continue the trial”. When this is all over I look forward to hearing from the IDMC what they saw, thought and reported in September/October and possibly testifying to it.

Well, as best as I can understand it, there is no ongoing trial. They are, essentially, simply monitoring the results from a completed trial. These results could be unblinded to a certain extent. Think of it this way: Provenge might have already passed the hurdle, but nobody knows because you can’t see.

The situation with Provenge is unique like no other (Phase I, II, III (2) and now a continued larger phase III with early survival evidence, 10 years of study at a cost of 600 million). Special considerations are earned and due from the FDA because they denied Provenge proper due process the first time around and because of the great need for a treatment for a class of patients with no good alternative treatments available.

If Provenge didn’t work you could have equally likely have seen increased survival in the placebo arm. If Provenge did not work and was doing nothing, then a 20% increased survival in the placebo arm was just as likely as a 20% increase in the Provenge arm (stats guys feel free to correct me if I am wrong). I suppose the FDA just thinks that Provenge is so very lucky and they just keep achieving all these results by mere chance and that it follows the same cosmic chart as it previously has done. All by pure chance?

Horse pucky!

Those that make these decisions will one day be called before Congress or the Courts to answer for the DELAYS caused by these decisions they have made and continue to make. They keep passing on their chance for redemption. Just think later the IDMC will be able to talk and we will without doubt have a final FDA decision at some point that cannot be shunned by Congress or the Courts on the issue of finality or ripeness. What then FDA??

Andy may have slinked off but other FDA officials will have to answer and I am not so sure Andy won’t be called back to answer as well. Whether Congress or the Courts have recognized it there will still come a day when the capricious actions and inhumane delay in making Provenge available to the patients will have to be addressed by the FDA. A case study in FDA administrative ineptitude in the case of Provenge may be a college Administrative law or Constitutional law class in colleges around the world for a decade to come.
As I have said before this case is going back to the FDA for certain. Once the results are in then there will be time needed to prepare the new BLA and then possibly an 8 month FDA review. Why do patients have to wait until 2010.

Why, oh why, can’t we get some humanity and speed this treatment to patients who so desperately need it. What will it take to get this moral outrage spread to the world?

Last night on O'Rielly, Glen Beck was on and he was asking what has happened to moral outrage. Why now do people just accept moral outrageousness and just move on without expressing the moral outrage that that they feel. (yes I will again try to communicate my moral outrage to Beck and in fact will CC him this post....I have sent him many previously w/o response). Everyone continue to express your moral outrage about Provenge to everyone you can.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.960.613 von GuHu1 am 15.11.08 20:43:13

Der Kurs hält sich super stabil oder wird stabilisiert!
Vielleicht kommts doch noch zu einer vorzeitigen Zulassung!

[GuHu1]

Antwort auf Beitrag Nr.: 35.979.518 von Magnetfeldfredy am 17.11.08 17:20:32

jo, hält sich derzeit wacker um die $5.

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=232169&pt=…

CC notes and I agree, moon, clarified a couple small issues I had

1. As p3 noted... expect FINAL results in "mid-2009".

2. "only need 22%; Interim was 20% and I feel a lot better about that"

3. "median" survival in 9901 and 9902a was 4 1/2 months.. key is "median".. which as I recall means 1/2 of the number of patients fell below that number and 1/2 were above that number..

4. OS was 41% overall death reduction
3 yr survival was 34% vs 11% for placebo
Curves begin to separate in prior trials at 10 months

5. IMPACT has 88% power for a 1.45 HR @ 304 events at FINAL was their plan

6. May 08 was data cutoff for INTERIM

***7. "MEDIAN" followup time had patients at ~24 months with a 20% reduction in death in Provenge arm compared to placebo.
Treatment effect INCREASED over time comparable to prior PIII trials

***8. IF 20% increase in reduction of death at Interim goes to 22% reduction in death at FINAL analysis, we will expect to meet the Primary Endpoint.

***9. Our own sales force of 125 are expected to meet the needs

*******10. Currently Dendreon owns 100% world-wide rights; ROW.. we'll see partner AFTER Final Analysis

11. 100,000 patients available for Provenge treatment in US (MY NOTE: Multiple that by your expected treatment cost to get an expected sales figure)

***12. TRP-P8 - "important in-house discovery". The ion thingy is 100% in PCa; major in Breast, Melanoma, Colo-rectal and Lung cancers. Also may treat BPH.

13. "Why am I encouraged by Interim data?" asked Mitch
24 months in Integrated Dated showed 22%; 36 month showed 33% reduction in risk of death

*** IMPACT Interim, the 24 month comparison comes from patient population... [MY NOTE: which seems to clarify to me the discussion of last week on the 24 month median comparision to Integrated Data from prior trials. My take on this comment is the IMPACT patients had about a 24 month MEDIAN at INTERIM look]

*****14. IMPACT needs to get from 20 to 22% and I feel better about it.

***15. 9902a patients SICKER than 9901 AND "IMPACT is more similar to 9901"

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 35.997.036 von GuHu1 am 18.11.08 22:14:46

Also mit zunehmender Zeit Zunahme des Überlebens! Das klingt sehr sehr gut!

[GuHu1]

Antwort auf Beitrag Nr.: 35.997.361 von Magnetfeldfredy am 18.11.08 22:40:58

ja klingt gut, muss jetzt auch bestätigt werden!

[GuHu1]

http://www.cnbc.com/id/27911250/site/14081545?__source=yahoo…

[GuHu1]

http://www.earthtimes.org/articles/show/market-for-cellular-…

http://www.cnbc.com/id/28016874/site/14081545?__source=yahoo…

[GuHu1]

http://www.pharmalot.com/2008/12/provenge-activists-fail-to-…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.134.788 von GuHu1 am 02.12.08 22:00:36

D.H. We have to wait!

[GuHu1]

Antwort auf Beitrag Nr.: 36.143.974 von Magnetfeldfredy am 04.12.08 06:51:03

davon sollte man derzeit ausgehen, oder.

[GuHu1]

http://my.nowpublic.com/health/hedge-funds-cancer-patients-d…

[Uptick08]

Antwort auf Beitrag Nr.: 36.156.076 von GuHu1 am 05.12.08 17:28:25

Krass...echt krass:O

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.156.076 von GuHu1 am 05.12.08 17:28:25

Was ist das?

Form 8-K for DENDREON CORP


--------------------------------------------------------------------------------

8-Dec-2008

Amendments to Articles of Inc. or Bylaws; Change in Fiscal Year, Other Events, Fina



Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
(a) On December 3, 2008, the Board of Directors of Dendreon Corporation (the "Company") approved the amendment of the Company's Amended and Restated Bylaws (the "Bylaws"). The changes affect Article III of the Bylaws filed as Exhibit 3.2 hereto, and reflect the Company's desire to clarify and further define the advance notice provisions in the Bylaws. Additionally, the Board of Directors approved the amendment and restatement of the Company's Bylaws to make certain other changes to the Bylaws as the directors deemed necessary, appropriate or desirable. For the full text of the New Amended and Restated Bylaws please see the attached exhibit.





Item 8.01 Other Events.
On December 3, 2008, the Board of Directors waived the provisions under Section 7 of the 2000 Equity Incentive Plan (the "Plan"), which would have provided an automatic annual option grant for existing directors for the 2008 year. In lieu of the automatic option grant, the Board of Directors determined to award the Company's directors 12,500 shares, which will vest upon grant in January 2009.

Also on December 3, 2008, the Board of Directors approved a new offering under the 2000 Employee Stock Purchase Plan ("ESPP"), to commence January 1, 2009 (the "2009 Offering"). The 2009 Offering will be on substantially the same terms as the the current ESPP offering that commenced on January 1, 2007 and will expire on December 31, 2008. The 2009 Offering is filed as Exhibit 99.1 hereto.

[GuHu1]

Antwort auf Beitrag Nr.: 36.174.014 von Magnetfeldfredy am 09.12.08 16:42:28

13. monatsgehalt

http://www.investorvillage.com/smbd.asp?mb=971&mn=234199&pt=…

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=234336&pt=…

Provenge FYI-on topic
I attended a sanofi dinner last pm about taxotere and prostate ca.. The speaker was from hopkins, a med onc and very knowledgeable with an md phd and an interest in immunology. We talked about gvax and provenge. As you know hopkins was involved with gvax. It seems hopkins has an interest in targeting a cd4 like protein for prostate now. I dont know if cege has any role in that. They have money but no prostate product in the pipeline.

Anyway, he knew all the details of provenge. He gave it a better than 50% chance for a positive impact. The fda most always wants a confirmatory trial. He didnt realize though that provenge benefited high grade patients as well, which upped his estimate of the chances for impact success a bit.

I also heard provenge mentioned in a recent audio cd about prostate ca as an example of a stuation where the primary and surrogate endpoints for success need to be different than conventional chemo for immunotherapy. There is debate as to what a good surrogate would be but progression free survival isnt one of them for immunotherapy.

So the results of impact are being widely anticipated in the academic world. As everyone is aware the chatter by the hedge funds and so called bioanallysts is to be ignored. The more they downgrade the more encouraged I become.

[GuHu1]

http://www.zacks.com/stock/news/16635/Pharmaceuticals+Indust…

.......Here is one of our favorite stats: Pfizer's $30+ billion in cash is enough to buy Biogen Idec (BIIB), Amylin (AMLN), Forest Labs (FRX), Sepracor (SEPR), Dendreon (DNDN), Arena (ARNA), Onyx (ONXX), OSI Pharma (OSIP) and Elan (ELN) -- all without issuing one share. Watch for Pfizer to put its cash to work in 2009 to help grow that stagnant top-line in the future........

[NoSelters]

Hallo zusammen....

Hab ein Problem. Das Arca-Webbook ist seit 12.01. nicht mehr gratis.
Hat mir jemand nen Link zu anderen,kostenlosen Realtimekursen??

Vorab VIELEN DANK !

Grüsse

No

[GuHu1]

Antwort auf Beitrag Nr.: 36.358.175 von NoSelters am 12.01.09 19:24:32

schau mal im ELN thread.

http://www.wallstreet-online.de/diskussion/985574-21501-2151…

[NoSelters]

Antwort auf Beitrag Nr.: 36.359.071 von GuHu1 am 12.01.09 21:31:18

Hi Guhu.
Danke,ist zwar nicht so komfortabel,da keine automatische Aktualisierung,aber ich werd mich dran gewöhnen.

Hätte Dir übrigens fast gratuliert heute früh. ELN hatte bis zum Handelsbeginn bei CoDi mit 201% im Plus notiert.Kurs und Chart bei ca. 26.
Aber aufgeschoben ist nicht aufgehoben!

Grüssle.

No.

[GuHu1]

hi no, ich hoffe das wird noch mit ELN.


DNDN:

http://vfcsstockhouse.blogspot.com/2009/01/vfcs-2009-stock-p…

[GuHu1]

http://www.cnbc.com/id/15840232?video=996650057&play=1

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.367.413 von GuHu1 am 13.01.09 21:45:25

Gold ist sich ja ziemlich sicher daß Provenge works, die 22 % Überlenbensrate wird DNDN hoffentlich packen!
Gibt`s auf der Conference in San Francisco News zu Provenge?

[NoSelters]

http://www.schaeffersresearch.com/commentary/content/option+…

No

[GuHu1]

Antwort auf Beitrag Nr.: 36.370.474 von Magnetfeldfredy am 14.01.09 12:06:18

nicht das ich wüßte freddy, aber die nächsten zwei tage könnten interresant werden.

[GuHu1]

Antwort auf Beitrag Nr.: 36.370.474 von Magnetfeldfredy am 14.01.09 12:06:18

nah jetzt bin ich mal gespannt, freitag ist options day!!!!!!!!!!

Webcast tomorrow at 11:00 a.m. Pacific Time
Press Release Source: Dendreon Corporation

Dendreon Announces Webcast Presentation at 27th Annual J.P. Morgan Healthcare ConferenceThursday January 8, 7:30 am ET

SEATTLE, Jan. 8 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that management will present at the 27th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 15, 2009 at 11:00 a.m. PT.

A live audio webcast of the presentation will be accessible through the Investor Relations section of the Dendreon website, http://www.dendreon.com. If you are unable to listen to the live webcast, it will be archived on the site following the presentation. To access the replay, go to the Investor Relations section of the website.

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 is also developing an orally-available small molecule that targets Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters 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 www.dendreon.com.

Source: Dendreon Corporation

[GuHu1]

http://www.businesswire.com/portal/site/google/?ndmViewId=ne…

[GuHu1]

http://www.tradingmarkets.com/.site/news/Stock%20News/212623…

[GuHu1]

Antwort auf Beitrag Nr.: 36.376.977 von GuHu1 am 14.01.09 22:34:11

final impact daten werden im april erwartet.

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=238535&pt=…

Tune in tomorrow, folks
I can't tell you if its going up, down or staying flat, but it's gonna be an historic day. 250,000 7.50s to close, not to mention hundreds of thousands more contracts at higher strikes (combined). I'm starting to think that Ming is right a people will take delivery. I cannot see that many contracts trading in one day. That would be nice, because I don't see where all those shares are coming from.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.385.187 von GuHu1 am 15.01.09 22:13:35

Servus GhHu1,

auch ich habe mir die Webcast Präsentation reingezogen und Mr. Gold ist überzeugt, daß sich mit längerer Behandlung mit Provenge auch die Überlebensraten verbessern, also von 20 % auf 22 % den benötigten Endpunkt, daß müßte doch klappen!
Im April ist der große Showdown, nicht mehr lange!

Was mit den Optionen läuft kapier ich nicht, kannst Du mir das erklären? Danke vorab!

Ich hab auf 3.000 Stück aufgestockt!

[GuHu1]

Antwort auf Beitrag Nr.: 36.385.301 von Magnetfeldfredy am 15.01.09 22:29:08

hi freddy ( alter leidensgenosse )
außergewöhnlich viele optionen werden morgen fällig.
es könnte,sollte, würde, vieleicht, möglicherweise... einen regen handel geben, positiv wie negativ.
im IV ist die meinung auch gespalten, einige machen einen positiven trend aus aber halt nicht alle!

ist hier keiner der sich mit optionen der besonderen art auskennt?
wie siehts aus ippolit, bist sicher ein eifriger leser der zu gegebener zeit immer einen schlauen kommentar drauf hat, jetzt wäre der richtige zeitpunkt! dann aber bitte zu den optionen!!!!!!

...und Mr. Gold ist überzeugt,...
klar dafür wird er auch bezahlt.

..Ich hab auf 3.000 Stück aufgestockt!...
mutig!

wünsch uns glück, denn auch das brauchen wir

[GuHu1]

stat guy aus dem IV

http://www.investorvillage.com/smbd.asp?mb=971&mn=238555&pt=…

RE Help Ocyan and others

The possibility of the 304 trigger ending in Dec/Jan has been clear in running simulations for quite some time. That was reinforced by Greg Schiffman's inadvertent slip in one of his presentations late last year that the trigger might come at the end of 2008. So the announcement today was not a surprise to me. It was just a direct consequence of a long drawn out enrollment schedule that took place over 4 years. In fact, this prediction could have been modeled with the unaltered integrated data.


Now, to the power estimation. To be consistent with the interim HR data and the timing of both triggers, my sims say that the control arm of IMPACT must be doing about 8-9% better than the control arm of the integrated data while the IMPACT's treatment arm is similar to the integrated or just slightly better (likely a result of Taxotere being SOC). With that, the power of the 304 trigger should be between 54% to 58% assuming that the interim trigger was around the 230, 240 area.


Unlike the interim look where the database was locked and kept blind at the trigger, this time the database will be unblinded at the final analysis. As such, Dendreon will also have data on patients who died in the next 3-4 months while they are cleaning the data. In that case, the final number of events available for data analysis might be much higher than 304, possibly reaching around 330. For this analysis, the conditional power would be about 70%. Jimmy - hope you are right here.[/i]

[hakur]

Antwort auf Beitrag Nr.: 36.385.450 von GuHu1 am 15.01.09 22:57:41

hi Guhu

stelle mal ausnahmsweise bezüglich des Options Verfallstages einen E-mail Komentar eines Amis rein mit dem ich in Kontakt stehe.

Er hat mir folgendes geschrieben auf meine Frage wo er den Kurs am Freitag sehen könnte infolge des Verfallstages.



The point of minimum payout is at $9.50

This is where the market makers would like to take the pps on Friday. As a practical matter this is extremely unlikely. However, your target at $6.51 is well within the realm of possibility. Certainly, I expect the price to exceed $5. Anything, however, is possible here. We know that there are large and powerful players manipulating the price of DNDN.

Be
Soweit ich es verstanden habe müssen die Markedmaker den Preis hochziehen um nicht die unglaubliche Zahl von 60 Millionen Aktien liefern zu müssen für die entsprechenden ausstehenden Put Contracte.
Bitte korregiert dies falls notwendig. Bin kein Profi was Optionen anbelangt.


immer noch "so looong"

[GuHu1]

Antwort auf Beitrag Nr.: 36.385.580 von hakur am 15.01.09 23:30:20

thx hakur! a-tech?

[GuHu1]

http://www.cnbc.com/id/28679865/site/14081545?__source=yahoo…

[GuHu1]

http://www.biohealthinvestor.com/2009/01/trader-take-on-dend…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.385.450 von GuHu1 am 15.01.09 22:57:41

Danke für die rasche answer!

Ich persönlich glaube und hoffe für alle Prostatakrebskranken daß Provenge zugelassen wird und die Chancen dafür stehen gut, in meinen Augen sogar sehr sehr gut!
Natürlich kann auch wieder nur eine Überlebensrate von z.B. 21 % erreicht werden....
Ja ich bin mutig, denn nur die Mutigen werden an der Börse belohnt oder zerrissen, ich werde sogar auf 5000 Stück aufstocken!
Ist doch viel besser wie Lotto, 15.000 EUR im Erfolgsfall auf ca. 60.000 EUR oder auf 5.000 EUR.

[GuHu1]

so könnte der knoten scheinbar zerschlagen werden, info aus IV.

This might help
From The Options clearing corporation prospectus, page 6:


G. Shortages of Underlying Interests. In certain circumstances involving shortages of underlying securities or currencies or in other unusual situations, OCC has the power to impose special exercise settlement procedures. These special procedures may involve delaying settlements or fixing cash settlement prices in lieu of delivery of the underlying security or currency. OCC does not have the power to fix cash settlement prices for put series opened for trading prior to September 16, 2000. However, it does have the authority in such circumstances to prohibit the exercise of such puts by holders who would be unable to deliver the underlying security or currency on the exercise settlement date. In the event of a shortage of an underlying debt instrument, OCC may permit the delivery of other, generally comparable securities, and may adjust the exercise prices of affected Options to compensate for such substitute deliveries.

http://www.cboe.com/LearnCenter/Workbench/pdfs/OptionsCleari…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.391.737 von GuHu1 am 16.01.09 18:28:20

Anscheinend haben die Puttis heute die Oberhand!

[GuHu1]

Antwort auf Beitrag Nr.: 36.393.026 von Magnetfeldfredy am 16.01.09 20:52:37

lang lebe die freie marktwirtschaft!

You are about to witness...imo. "pre-arranged" and "non-competitive trading....
This goes beyond the "pale." In front of the world...the SEC...and brokerage houses with all their "dumbshmuck" retail chumps (like me and you)...vaporize all these puts within people working with each other...imo...people possibly like Citidal and SAC, among others for instance...either the trades are crossed at the end of the day...or swapped within accounts after the close. IMO...if you or I did it we would be looking at fines and jail...the equiv. of 40 million shares are going to just vanish...amazing...

[GuHu1]

Antwort auf Beitrag Nr.: 36.385.301 von Magnetfeldfredy am 15.01.09 22:29:08

hab dir mal ne mail geschickt.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.400.139 von GuHu1 am 19.01.09 00:14:28

Ich hab mir nochmals die Webcast Präsentation reingezogen, für mich überwiegen die Chancen einer Zulassung!
Drücken wir uns und den Kranken die Daumen!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.400.139 von GuHu1 am 19.01.09 00:14:28

Neue Analyse, die Keinem was bringt!

New York (aktiencheck.de AG) - Reni Benjamin, Analyst von Rodman & Renshaw, stuft die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) mit dem Rating "market perform" ein. (16.01.2009/ac/a/u)

Na ja wenigstens kein sell mehr!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.408.870 von Magnetfeldfredy am 20.01.09 10:43:12

Ja im Laufe des Tages ist mir das Lachen vergangen:

Dendreon Update

In a follow-up to my post from late last week, shares of DNDN [DNDN 3.74 -0.51 (-12%) ] hit a new intra-day low this morning.

Jonathan Aschoff at Brean Murray Carret & Co. put out a research note to clients this morning to "strongly reiterate" his sell rating and price target of a buck. He believes the earlier-than-expected milestone reached in the pivotal clinical trial of the company's experimental prostate cancer treatment isn't bullish for the final results now expected in April. Brean makes a market in DNDN and would like to do investment banking for the company. But despite the wall that's been put up between research and banking, I can't imagine Dendreon--or any company for that matter--giving a firm with that kind of bearish position the business, so to speak.

Hoffentlich hat er nicht Recht, er kann auch nicht mehr wissen, oder?

[NoSelters]

Antwort auf Beitrag Nr.: 36.413.746 von Magnetfeldfredy am 20.01.09 19:41:42

Tja,das sind nun nochmals richtig "Schmerzen"...
Wobei ich Aschoffs Empfehlung weiterhin als Kontraindikator werte!

Hab heute meinen Einstandskurs vom März 2007 wieder erreicht.

Da helfen nur starke Nerven und im Notfall PC ein paar Tage nicht anfassen.

Good Luck

No

[NoSelters]

Antwort auf Beitrag Nr.: 36.413.820 von NoSelters am 20.01.09 19:51:23

....und es dürften jetzt alle gaps geschlossen sein!!!

Schaun ma mal

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.413.820 von NoSelters am 20.01.09 19:51:23

Ich bleib auch investiert, auch wenn derzeit sehr weht tut!

[NoSelters]

... Hakur ??

Ich denke Du bist auch noch dabei und erlaube mir,Dich um Deine Meinung zum veränderten(?)Chartbild zu befragen.

Danke vorab!!

Gruss,

No

[GuHu1]

Antwort auf Beitrag Nr.: 36.413.746 von Magnetfeldfredy am 20.01.09 19:41:42

na ja ich denke nicht dass die mehr wissen, aschoff predigt die $ 1,00 seit May 2007.
ich sag ja 50:50, ocayn (IV stat. guy) ist nicht über den trigger im Jan überrascht, aschoff wertet diesen als negativ.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.415.307 von GuHu1 am 20.01.09 23:02:04

Servus GuHu1,

kannst Du mir das näher erklären:
ocayn (IV stat. guy) ist nicht über den trigger im Jan überrascht

Ist der besagte Analyst nicht wegen Falschaussagen schon mal eingesessen oder verurteilt worden kann mich daran erinnern als er Sangamo niederschrieb, leider zurecht!

[GuHu1]

Antwort auf Beitrag Nr.: 36.416.197 von Magnetfeldfredy am 21.01.09 08:41:50

hi fredy,
dazu ist zu sagen, OCYAN und andere lassen parallel simulationen laufen, grundlage sind die zur verfügung stehenden daten sowie die vorangegangenen studien. wollen wir hoffen er liegt richtig!


http://www.investorvillage.com/smbd.asp?mb=971&mn=240080&pt=…

Numerology - but not entirely.
<"Brean Murray said Dendreon Corp.'s (DNDN, $3.58, -$0.67, -15.76%) trial for Provenge, its prostate-cancer treatment, will likely disappoint when released in April. The company moved up the release date last week because it had hit threshold of deaths earlier than expected, which Brean Murray said affirms its fears that Provenge won't meet goals for reducing death rates, as highest percentage of deaths should come from late entries into the study." >

All below from simulations assuming that IMPACT is like a modified integrated data and the interim trigger was around 240.

1. Both the 240 trigger and the 304 trigger, or BM's "threshold of deaths", occured on time as predicted by the integrated data.

2. There were about 4 less deaths on the IMPACT control arm at 240 than if IMPACT acted like the integrated data. This difference was what lowered the interim HR from above 1.40 by the integrated data to just below 1.25.

3. If just a handful more events are added to 304 before locking the database to get, say, 310, the power of the final look will be about 62%.

4. By April, the number of events will be around 324. The power will be at about 70%. If stat sig is achieved the p value will likely be less than 0.03.

5. If that still fails, the company will likely elect to continue following patients a few more months. The 360 mark should be reached some time in Aug/Sept 2009 or perhaps a little later. The power will be about 90% for that look.

So, from a scientific point of view alone, unless IMPACT is completely whacky and behaves nothing like the integrated data, the evidence of efficacy should continue to get better. Within the year, it'll be indisputable.

If you invest based on science and logic, there is a basis for it, just be patient. And, Brean and their followers, be damned.
______________________

http://www.investorvillage.com/smbd.asp?mb=971&mn=238555&pt=…

Re: Help Ocyan and others
The possibility of the 304 trigger ending in Dec/Jan has been clear in running simulations for quite some time. That was reinforced by Greg Schiffman's inadvertent slip in one of his presentations late last year that the trigger might come at the end of 2008. So the announcement today was not a surprise to me. It was just a direct consequence of a long drawn out enrollment schedule that took place over 4 years. In fact, this prediction could have been modeled with the unaltered integrated data.

Now, to the power estimation. To be consistent with the interim HR data and the timing of both triggers, my sims say that the control arm of IMPACT must be doing about 8-9% better than the control arm of the integrated data while the IMPACT's treatment arm is similar to the integrated or just slightly better (likely a result of Taxotere being SOC). With that, the power of the 304 trigger should be between 54% to 58% assuming that the interim trigger was around the 230, 240 area.

Unlike the interim look where the database was locked and kept blind at the trigger, this time the database will be unblinded at the final analysis. As such, Dendreon will also have data on patients who died in the next 3-4 months while they are cleaning the data. In that case, the final number of events available for data analysis might be much higher than 304, possibly reaching around 330. For this analysis, the conditional power would be about 70%. Jimmy - hope you are right here.
____________________________________

http://www.investorvillage.com/smbd.asp?mb=971&mn=239083&pt=…

Re: Wow!!!moM
< what would be a reasonable reduction of percentage confidence in stat sig (due to undetermined confounding factor(s) possibly having entered the picture?), based on the 304th having occurred this month rather than a couple of months later as previously expected?>

It takes too much work to construct a dataset to answer your question and the value of that is small so I'll beg off doing that.

However, here is an example opposite to yours. Assume that IMPACT follows the integrated data exactly, the 304 trigger would have happened by the end of Jan with a 88.5% probability. In that case, if the interim was 240, the conditional power of the final would have been around 96%.

That is, with about the same timing for the 304 trigger, you could get either complete failure as in your example or near certain success as in the above much more plausible scenario that DNDN used to model IMPACT. There is a lot of room in between those extremes!

Data modeling is an art. So, here's warning: There is no guarantee in any of these power estimation exercises. DNDN just found out that out about their work with the interim results. I basically still assume the same integrated survival curves but with some modification to match the interim HR results and use that to extrapolate from. It's all that I can do at this time but who knows if that also might turn out all wet.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.422.196 von GuHu1 am 21.01.09 20:32:51

Danke für die Aufklärung, kannst Du mir
dies kurz deutsch zusammenfassen, mein Englisch ist nicht fachbezogen und die Erläuterungen verwirren mich!
Danke für Deine Bemühungen!

Ich bleib dabei!!!

[GuHu1]

http://www.investorvillage.com/smbd.asp?mb=971&mn=240202&pt=…

Kudos to Jimmy!!!!!!!!!!!!!!!!!!!!!!!! New emails to share:

I am GLAD the info I got in November was clarified, and WRONG!
JD-
1. Once the 304th event occurred, the data collecting and cleaning process was triggered. Once this process is completed, the database will be officially locked. It is not locked yet, as the data are still being collected and cleaned. Death events beyond the 304 will be taken into account for the final analysis. The 304 number is simply the number that triggers the database locking process. I hope this is clear. Thank you.
-Jennifer
=======================================
also:
2. The total death rate in IMPACT is consistent w/ the total death rate in Integrated.
for me, this is good news. IMPACT allowed slightly sicker men and late enrolees, and many ANAN-ysts have said this might be a negative?

3. 483 issue re-confirmation:"Per my previous email, we believe that the 483 issues have been resolved. That said, the FDA has not been back for a subsequent inspection and would not be expected to come back until after an amended BLA is filed, so I can not give you a definitive yes at this time. "( Nothing new)

4." Should we reach statistical significance at the final analysis, we will immediately proceed to the FDA to discuss the timing of an amended BLA. We will have more specific information after that time, but I can tell you that the company will be very focused on expediting the process!"

5. Debatable comment I am sure:
"Our goal was to accelerate the timing of the data analyses, which we did by approximately one year, while keeping the powering of the trial consistent. "

6. Lowering of the bar:
"The hazard ratio required to be successful at the final is lower than the hazard ratio required for success at the interim which is below the 1.45 target."
1.282+ needed at Final

7. Patient profiles:
"Also, the company has indicated that the overall patient profile for IMPACT is fairly equivalent to the patients in the D9901study and healthier than those in the D9902A study."

So, Impact patients are consistent w/ D9901 which yielded a HR of 1.7, 127 men enrolled, and slightly healthier than D9902A, which had a HR of 1.3? The pooled HR was 1.5. Overall, the death rates of Impact V Integrated are consistent(#2 above)
FWIW

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.423.531 von GuHu1 am 22.01.09 00:31:25

Daß hört sich doch ganz gut an, na ja, schlauer sind wir alle erst nach dem endgültigen Daten im April!

[NoSelters]

http://www.fda.gov/oc/viewpoint/default.htm

[Cyberhexe]

Was ich nicht verstehe - und dies habe ich auch im IV-Forum bereits zum Ausdruck gebracht (bisher keine Antwort) -, weshalb Provenge gegenüber Taxotere bzw. Mitoxandron in der Überlebenszeitanalyse bessere Ergebnisse erzielen muss. Vergleicht man nämlich das Nebenwirkungsprofil dieser konventionellen Chemotherapeutika mit der Vakzinierung, dann würden m.E. bereits ähnlich gute Ergebnisse eine Zulassung mehr als rechtfertigen.


Der Median beim Überleben nach Kaplan-Meier beträgt in der Taxotere-Studie bei PC lediglich ca. 18.5 Monate, derjenige von Mitoxantron gar nur 16.5 Monate. Sollte Provenge verglichen mit Taxotere unter vergleichbaren Bedingungen (Gleason-Faktor) ähnliche Ergebnisse erzielen, dann ist nicht einzusehen, dass diese neue Therapieform den Erkrankten vorenthalten wird.

http://www.emea.europa.eu/humandocs/PDFs/EPAR/taxotere/05889…
Table 10: Primary Efficacy Variable – Overall Survival, ITT

4.8 Nebenwirkungen
http://www.emea.europa.eu/humandocs/PDFs/EPAR/taxotere/H-073…

[NoSelters]

Antwort auf Beitrag Nr.: 36.426.720 von Cyberhexe am 22.01.09 14:16:51

Welcome back..Hexchen!!

Jetzt muss es ja bald losgehen.

Gruss,

No.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.427.704 von NoSelters am 22.01.09 15:54:13

Die offenen Stellen sind laut Homepage von Dendreon auch wieder von 10 auf 12 gestiegen, gesucht werden Leute in Seattle, der Produktionsort von Provenge?

[GuHu1]

Antwort auf Beitrag Nr.: 36.426.720 von Cyberhexe am 22.01.09 14:16:51

Hi schön hier mal wieder was von dir zu lesen.

na hoffen wir mal das das mit dem vorenthalten nicht mehr allzulange dauert.

@fredy
das posting von jennifer ( Investor Relation Dendreon) ist recht aufschlußreich.

ocyan wird bzgl. des 304 triggers im nachhinein durch Jennifer bestätigt.

[NoSelters]

Antwort auf Beitrag Nr.: 36.430.194 von Magnetfeldfredy am 22.01.09 19:55:38

Das hat nicht viel zu bedeuten,müssen nicht unbedingt neue Stellen sein.
DNDN wird die Personaldecke erst nach Vorlage von positiven Finaldaten,aber vor einer Zulassung,aufstocken....dann aber gewaltig.(hatten wir ja schon mal vor knapp 2 Jahren)

Durchhalten!

No

[GuHu1]

Antwort auf Beitrag Nr.: 36.426.720 von Cyberhexe am 22.01.09 14:16:51

vieleicht solltest du die frage direkter stellen.
könnte mir gut vorstellen das die eigentliche frage unterging!

[edelupolino]

Hi, ihr hoffenden,

ein sehr sachlicher und überzeugender brief über coi von Scher etc wurde an den neuen Commish geschrieben:

http://www.investorvillage.com/smbd.asp?mb=971&mn=240436&pt=…

Ihr seht, unsere amerikan. freunde lassen nicht locker.

Ciao Ede

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.433.357 von edelupolino am 23.01.09 10:28:21

Nicht uninteressant, oder?
Dendreon

I think I’d probably get strung up if I didn’t mention Dendreon (DNDN), given their recent news.

At the JPMorgan conference, Dendreon announced that the final analysis of the IMPACT trial would arrive in April. This caught some folks by surprise, since the company had been forecasting mid-year. It also caused some analysts who don’t know as much about statistics as they think they do to opine this “early” arrival of the analysis means the drug doesn’t work.

Even assuming the analysis is “early,” it doesn’t tell us the trial is a failure any more than late data implies the trial is a success. In this case, it does tell us the trial may be running differently than the previous 2 Phase III trials of Provenge. That does imply increased potential risk for investors counting on simply a repeat of the previous trials, but it does not imply success or failure.

Dendreon has released data showing how IMPACT patients are generally the same as patients in the initial two Phase III trials of Provenge in terms of projected survival at entry, crossover to Provenge from the control arm, and a couple of other metrics. They also disclosed in October that the performance of Provenge arm compared to the control arm was positive and within hailing distance of the performance seen in the initial two trials.

We already know this is not going to be another GVAX. GVAX is another prostate cancer immunotherapy created by Cell Genesys (CEGE). My firm predicted failure of this drug for years, and two Phase III trials showed GVAX patients doing no better and in some cases worse than patients who didn’t get the drug.

Provenge, in contrast, showed a 20% survival benefit over the control arm at the interim analysis. That 20% wasn’t big enough to trigger a successful end to the trial at the interim, but 22% will be enough to trigger success at the final.

So, long-suffering Dendreon bulls (like me) will be rooting for those extra 2 points of patient benefit.

The last time good news arrived for Dendreon (in the form of a positive advisory panel vote that was later overruled by an FDA whose decision was mired in internal politics and conflict of interest), the stock opened in pre-market up nearly 400%. It closed the first day up about 150%, then soared to the mid-$20 range (up over 500%). Those ranges are certainly in play this time if the final analysis in April is cleanly met. Options activity has been heavy.

For those interested in learning more, my firm has been covering Dendreon since 2000. I’m not sure there is anyone out there who knows more about the company than we do. We’ve been right for years about the science and fundamentals, though my prediction of an 80% chance of FDA approval after the advisory panel vote turned out to be wrong when the FDA took the unprecedented step of overruling their advisory panel on a drug for a life-threatening condition. The FDA overruled advisory panels before, but never to reject a drug for a life-threatening condition that an advisory panel decided met the criteria for FDA approval.

In a note out this week, we straightened out some misconceptions about how the final analysis will be conducted and outlined some alternative paths to approval if the analysis specified in the Special Protocol Assessment for the IMPACT trial is not a clean success. These clarifications would be especially helpful to anyone who is running statistical models on the outcome of the IMPACT trial.

For those interested in the story, our work provides a factual counterpoint to some of the sell-side analysts out there. Those analysts can certainly be congratulated for their correctness on the price action, but some haven’t got a single fundamental prediction right yet (other than the aforementioned rejection by the FDA – which I’m the first to admit was a big one to get right even if they did so by flying in the face of a couple of decades of FDA precedent).

In any case, April should be an “interesting” month for those of us who follow the stock.

<< Prev 1 | 2 | 3

[GuHu1]

Antwort auf Beitrag Nr.: 36.440.008 von Magnetfeldfredy am 23.01.09 21:34:28

yep fredy

anbei der link:

http://www.minyanville.com/articles/PFE-BMY-NBIX-WYE-ZGEN-rp…

[GuHu1]

http://blogs.wsj.com/marketbeat/2009/01/23/four-at-four-gene…

From The Wall Street Journal's Marketbeat...
It’s been a rough week for Dendreon, a biotechnology stock with a fervent group of followers that wait with baited breath for every bit of news about its Provenge treatment for prostate cancer. The stock was hit hard earlier in the week after news that data from company’s ongoing trial for its treatment will be released in April, earlier than expected, because the trial has surpassed the threshold for number of deaths to incur a final analysis. The problem, as some Wall Street analysts see it, is that the company amended its trial late in the process to include sicker patients. The drug needed to show a 22% reduction in the risk of death to be successful, and it was at 20% earlier in the trial. “We firmly believe that the death events occurring after the May 2008 cutoff date consist of a greater percentage of patients that were enrolled later in the trial (i.e., sicker patients), which would make it even harder for any drug to offer interim analysis,” write analysts at Brean Murray Carret & Co. “Therefore, the 20% difference reported at interim is actually further from the 22% goal required at final analysis than it may seem at first glance.” Some are remaining optimistic, however, including David Miller, who writes on Minyanville.com that “long-suffering Dendreon bulls (like me) will be rooting for those extra 2 points of patient benefit.” This stock has been a volatile one — and if the 22% threshold is reached, expect wild action. Shares hit a 52-week low of $3.42 Tuesday.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.440.840 von GuHu1 am 24.01.09 01:10:17

Du bist ja lange nachts aktiv, ich bleibe dabei 50% Chance bleibt!
Und das Risikoprofil von US Dollar 3,50 auf z.B. 1 USD bzw. von USD 3,5 auf 15 USD bleibt höchst attraktiv, oder?

Was mich interessieren würde, wissen die von Dendreon schon die final dates oder auch erst im April?

[GuHu1]

Antwort auf Beitrag Nr.: 36.440.994 von Magnetfeldfredy am 24.01.09 08:28:17

die erkenntnis wird von woche zu woche steigen.
hab übrigens wiedersprüchliches zum thema 304 trigger gelesen, warte aber noch auf aufklärung.

wenn du selber schaun willst, hier der link zur diskussion:

http://www.investorvillage.com/smbd.asp?mb=971&mn=240700&pt=…

[GuHu1]

Antwort auf Beitrag Nr.: 36.441.840 von GuHu1 am 24.01.09 13:27:03

http://www.investorvillage.com/smbd.asp?mb=971&mn=240764&pt=…

<FDA will accept only the HR and p value calculated from the first 304 events.>


The correct statement is that the SPA applies only to the HR and p value calculated from the first 304 events. But that does not preclude the FDA from accepting data not quite as clear cut for considering licensing.


http://www.fda.gov/cder/foi/nda/2003/20-297s009_Coreg.htm


The FDA do accept a variety of data from trials not meeting their primary endpoints. A case in point is Carvedilol. Read the conclusions from the Clinical and Statistical Reviews in the link above.

The pivotal trial Capricorn of Carvedilol was changed midstream causing both co-primary endpoints to miss. In fact, the major primary endpoint Death+Hospitalization with alpha 0.045 missed widely with p=0.297! But the FDA reviewers did favor the Overall Survival endpoint with p=0.031 even though it also missed the pre-specified alpha 0.004.

Pay attention to their comments on the "frequentist viewpoint" and in the subsequent paragraphs. That type of reasoning could be applicable again should the 304 trigger misses but other supportive data are consistent, in particular, if a secondary survival analysis with more events comes in under 0.05.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.443.582 von GuHu1 am 25.01.09 00:39:07

I have finally gotten around to writing about some of the annual reports I have sifted through in the past month. The first one I am writing about today is Dendreon (DNDN), one of my Top Ten Stocks for 2009.

Dendreon had a nice 2007 as far as its pipeline was concerned. The company submitted Provenge to the FDA office of Cellular, Tissue and Gene Therapies Advisory Committee. That committee passed Provenge with a 17-0 annonymous vote and deemed Provenge "Reasonably safe". In March of 2007 Dendreon submitted Neuvenge, a drug that will be used in relations to breast cancer, into Phase I trials. This drug Neuvenge could also later be used for ovarion, colon, and bladder cancers based on its formation.

The company has CEA in preclinical trials. This targets lung cancer, colon cancer, and breast cancer. CA9, another preclinical drug, is aimed at a protein found in 75% of cervical cancer, and 95% of renal cancers.

TRP, an iron channel that regulates flow of iron in cells could be made into a pill by the company, and is likely to be sent as an IND in 2009.

The first phase III trial of Provenge demonstrated median survival benefit with Provenge of four and a half months and an amazing 41% reduction in death. In the same study it was found that 34% of patients were alive 36 months after the trial, compared with 11% of the placebo control groupl.

The lead doctor of the Impact study of Provenge has 21 years of practice and is a Harvard Professor of Medicine.

The company Dendreon has no revenue and as stated by the Risk Factors in the Annual Report, it is highly dependent on the FDA approval of Provenge.

The stock traded as high as $25.25 in 2007 and can now be bought for a fifth of that price per share. The company is now reporting that April will be the key month to watch for a report on Provenge.

I recommend the stock as a Speculative buy. I do not own shares of the company at the time of this writing but will be looking at adding some under the $5 range from now until March.

Provenge will pass trials, it will save lives. The company will have an amazing drug and will get bought out.

This article also appears on my blog here.

[huetchen6]

Antwort auf Beitrag Nr.: 36.443.582 von GuHu1 am 25.01.09 00:39:07

jetzt hat der CEO- Gold sein Fett.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.461.762 von huetchen6 am 28.01.09 08:08:26

Warum hat er jetzt sein Fett, wer sagt, daß die 22% Überlebensrate nicht erreicht worden sind?

[huetchen6]

Antwort auf Beitrag Nr.: 36.462.849 von Magnetfeldfredy am 28.01.09 10:41:29

der meint Er kommt gegen die FDA u. Chemos an, jetzt geht im langsam das Geld alle, dann kann er seine Klitsche für ein Apfel u. Ei verkaufen.
Provenge erfüllt sein Teil, der CEO ist verkehrt am Platze, diese müssen alle ausbaden. ( Milliardenbereich wo er sich aufhält, und frägt auch nicht nach den Kranken.)

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.463.057 von huetchen6 am 28.01.09 11:09:20

Wart doch erst den April ab dann sind wir Alle schlauer und dann kannst Du Gold fertigmachen oder auch feiern!

[NoSelters]

Jetzt kanns losgehn...

[NoSelters]

Antwort auf Beitrag Nr.: 36.469.575 von NoSelters am 28.01.09 21:30:26

Irgendwie muss man halt den Frust bewältigen.

[huetchen6]

Antwort auf Beitrag Nr.: 36.469.575 von NoSelters am 28.01.09 21:30:26

was heisst denn das.

[NoSelters]

Antwort auf Beitrag Nr.: 36.470.688 von huetchen6 am 29.01.09 06:19:44

Sorry,...funzt nicht mit dem Foto.
..Egal...

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.470.963 von NoSelters am 29.01.09 08:38:27

Es funzt auch mit dem Kurs nicht, jeden Tag fast neue Tiefs, Absicht, Täuschung oder bald bad news?

[NoSelters]

Antwort auf Beitrag Nr.: 36.477.053 von Magnetfeldfredy am 29.01.09 21:02:41

Tja fredy,wenn man's genau wüsste...

Ich persönlich glaube nach wie vor an ein glänzendes virtuoses Spiel der MM's nach Vorgabe der short investierten Hedgies.
Wir werden kein Eingreifen der SEC sehen und die Shortpositionen werden bis Ende März zum Großteil glatt gestellt sein.
Den Kurs sehe ich kurzfristig,eventuell nur Intraday,bei knapp unter 3 US$.
ABER DANN.... Ich hab ein gutes Gefühl.

So,genug mit Kaffeesatzlesen...

No

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.477.555 von NoSelters am 29.01.09 22:01:08

Ja, daß hoffe ich auch und bleib dabei! Gute Nacht!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.477.694 von Magnetfeldfredy am 29.01.09 22:19:18

Three Possible Biotech Breakouts
by: Guru Alternatives February 03, 2009 | about stocks: DNDN / DSCO / MRX
Guru Alternatives
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Become a Contributor Submit an Article Font Size: PrintEmail TweetThis Clinical trial and approval news flow are the main determinants of value for a biotech. Incredibly, we have seen little biotechs soar to great heights during drug trials only to fall apart when the drug gets commercialized. If we have a reasonable appetite for extraordinary risk and still have any money left after 2008, there are three opportunities that can get very interesting in the next three months. Two of the three stocks has a catalyst that could either make or break it.

The wrinkle remover Medicis (MRX) is awaiting the approval of Reloxin, a type A botulinum vaccine. In 2006 the French drug company Ipsen granted Medicis rights to develop and commercialize its botulinum toxin product in the United States, Canada and Japan for aesthetic use. The development hit some wrinkles in 2007 when the FDA requested a re-filing of the BLA (Biologics License Application). The application was finally accepted in May 2008.

In January 2009, MRX announced the FDA action date of April 13, 2009. This would allow the company to participate in an estimated (2008) $300-$400 million market and compete against Allergan's (ALG) Botox. The approval would be a nice boost to its prospects especially in the aftermath of its steep decline to the low teens. There are analysts who have modeled $35 Million in revenues from this product for fiscal 2009. The consensus average of 15 analysts who cover this stock is an EPS of $1.67 for 2009. We believe that the low valuation and a powerful catalyst with a very high likelihood of approval is a decent trade. If you have the appetite for some risk, this may be a good start.

Our second candidate is a small biotechnology story Discovery Labs (DSCO) which simply ran out of luck with its FDA application after coming in with stellar data in 2002. We grew numb after watching the company get one approvable letter after another due to a seemingly endless list of manufacturing and stability issues. Our interest in this story is because of the strong trial data set and the fact that the FDA never asked the company to re-do its clinical trials. The product candidate is Surfaxin which is a synthetic version of the lung surfactant that allow normal lung function. After several stumbles we believe that the company may have finally gotten it right. The company is expecting FDA action on April 17, 2009. The approval is extremely crucial in this tough credit environment as the company may simply run out of time if it gets its wrong again.The more crucial the nature of the news flow, greater are the chances of a big move in either direction.

Our final candidate is an option play and has fans on both sides of the fence Dendreon Corporation (DNDN). The only product that really matters in this story is Provenge for the treatment of prostate cancer. The company is set to release the final analysis of its trial data on April 30, 2009. The company achieved a 20% reduction in the risk of death compared to placebo in an interim analysis that was announced in October 2008 for data collected up to May 2008. However, for approval the company needs to announce a 22% reduction. We believe that the extra eight months data between May 2008 and January 2009 would allow the needed 2%.

In each of the above special situations we have a powerful catalyst that has a high likelihood of success. All three belong to our aggressive risk portfolio and you should only get involved with money that you can afford to throw away. If things work out as expected the rewards could be stellar

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.501.967 von Magnetfeldfredy am 03.02.09 14:39:09

Company Update:

Dendreon Announces Webcast Presentation at Eleventh Annual BIO CEO & Investor Conference
Tuesday February 3, 7:30 am ET


SEATTLE, Feb. 3 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that management will present a company update at the Eleventh Annual BIO CEO & Investor Conference in New York City, on Tuesday, February 10, 2009 at 1:45 p.m. ET.
ADVERTISEMENT


A live audio webcast of the presentation will be accessible through the Investor Relations section of the Dendreon website, http://www.dendreon.com. If you are unable to listen to the live webcast, it will be archived on the site following the presentation. To access the replay, go to the Investor Relations section of the website.

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 is also developing an orally-available small molecule that targets Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters 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.

[GuHu1]

http://webcastingplayer.corporate-ir.net/player/PlayerHost.a…

Presentation
The presentation was interesting, but we still don't have clear picture of likely final results.

New stuff was:
Final analysis "by the end of April" according to one of the slides--and Gold said "in April" at one point.
Showed slides of nomograms suggesting patient populations in three studies are consistent and also showed slide of K-M curve for pooled results and blinded K-M curve for Impact study and they are right on top of each other.
Showed % survival at 36 months for entire patient populations of all three studies--again consistent at 26% between Impact and 9901.
Gold pointed out that in 9901 survival benefit was 22% at 24 month median and was 34% at 36 months--so 50% improvement over that period and only need 10% improvement in Impact to hit under SPA.

Still no way to know what the median time in the study is going to have been at the 304th death until results are reported. Fact is that if Impact was tracking 9901 exactly it would have hit 22% at interim and it didn't, so who knows if there is going to be a comparable improvement in the survival benefit between interim and final.

All we dedicated longs can do is hold our breath and wait. I believe and hope we'll hit 22%.

http://www.investorvillage.com/smbd.asp?mb=971&mn=243937&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.553.220 von GuHu1 am 10.02.09 21:27:02

Ich hab`s mir live angehört, scheiß Dialekt im amerikanischen Slang!
Super Bluffer oder Optimist? Who knows, I stay looooooooooooooooooooooooooooooooong!
Hab schon mal den Zug verpaßt, vor 5-6 Jahren mit Imclone, könnte sich wiederholen solch eine Jahrzentstory, oder?

[GuHu1]

Antwort auf Beitrag Nr.: 36.553.391 von Magnetfeldfredy am 10.02.09 21:45:13

tja, da bin ich mal gespannt.

Reuters
Feb 10 (Reuters) - Dendreon Corp:

CEO SAYS BLINDED NEW DATA FROM ONGOING PHASE 3 STUDY OF PROVENGE RAISE NO RED
flags

CEO SAYS BLINDED NEW DATA FROM ONGOING PHASE 3 STUDY APPEAR ON TRACK TO
confirm positive results of earlier phase 3 study

CEO SAYS POOLED BLINDED SURVIVAL DATA FROM PLACEBO, PROVENGE ARMS OF NEW
"impact" trial are similar to data seen at same 2-year mark in earlier "9901"
study

CEO SAYS TREND BOOSTS CONFIDENCE THAT FINAL DATA, TO BE UNVEILED IN APRIL,
will replicate earlier positive results

CEO SAYS COMPANY STILL AIMS TO KEEP FULL U.S. RIGHTS TO PROVENGE

((New York Equities Desk; tel: [phone])) (For more news about Dendreon Corp click here


COPYRIGHT


Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.

http://www.investorvillage.com/smbd.asp?mb=971&mn=244014&pt=…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.553.873 von GuHu1 am 10.02.09 22:47:02

Wäre zu schön um wahr zu werden, oder? Gute Nacht und danke für Deine Hilfe in Form Deiner mailings!

[hakur]

War hier schon lange nicht mehr präsent , von der charttechnischen Seite war auch nicht viel zu vermelden.

Habe mir nach der heutigen guten Präsentation von GOLD den langfristigen Chart unter die Lupe genommen und dabei diese interesssnanten Muster von wiederholenden fallenden Keilen gefunden.
Fallend Keile sind als bullisch zu sehen.( in der Regel)!
Auffallend dabei ist, dass der letzte fallende Keil just etwa im April sein Ende findet.
Ein Schelm der böses dabei denkt

Zufall oder was auch immer die fallenden Keile haben eine fast identische Zeitspanne bis zu ihrer jeweiligen Auflösung nach Norden.

Viel Glück für alle Looongs

Ps.kreuzt die Finger dass Regel der fallenden Keile auch hier greift, auf nach Norden

[GuHu1]

Antwort auf Beitrag Nr.: 36.553.930 von Magnetfeldfredy am 10.02.09 22:59:07

achte aber auf meine warnungen.
ich betrachte das weiterhin mit einer 50:50 change und kalkuliere auch den worst case ein.

[huetchen6]

Antwort auf Beitrag Nr.: 36.553.391 von Magnetfeldfredy am 10.02.09 21:45:13

darf man erfahren, wie ist es gelaufen, oder wie ist es passiert,
hat man daraus gelernt.
huetch.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.554.075 von GuHu1 am 10.02.09 23:37:36

Das ist mir klar, daß wir auch 50 % Chancen zum Scheitern haben, ich habs erlebt mit GPC Biotech, vor kurzem mit Bioms (ca. 50 % Niedergang an einem Tag!)....
Aber irgendwann muß es doch klappen, auch im Sinne der Prostatakrebskranken!
Mich würde brennend interessieren, ob Gold bis Ende April auch nicht mehr weiß oder eben doch?

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.554.063 von hakur am 10.02.09 23:33:51

Super Chartanalyse wenn auch hier nur die 22 % Überlebensrate zählen!