Dendreon...mit Provenge das erste Vaccin zur Krebstherapie? - 500 Beiträge pro Seite (Seite 9)

[NoSelters]

Antwort auf Beitrag Nr.: 29.561.822 von GuHu1 am 31.05.07 18:59:52

läuft...

Danke!

[xelon]

Antwort auf Beitrag Nr.: 29.561.822 von GuHu1 am 31.05.07 18:59:52

Guten Abend allerseits. Kann mich kurz jemand bitte aufklären worum es bei dieser Vorstellung um 19.00Uhr MEZ es sich handeln würde? Was tippt ihr für ein Schlusskurs für heute abend?

Schon mal danke im Voraus.

[NoSelters]

Antwort auf Beitrag Nr.: 29.561.949 von xelon am 31.05.07 19:07:05

http://www.investorvillage.com/smbd.asp?mb=971&pt=m


http://datasvr.tradearca.com/arcadataserver/JArcaBook.php?Sy…

Viel Spass!

[NoSelters]

Eine blitzsaubere Analyse aus dem IV Board:

>>> What it all means...<<<
Short and sweet:

(1) Dendreon doesn't have enough cash to make it through this year.

(2) They need -- at a minimum -- a ROW partner that could supply an obviously much needed cash infusion plus muscle in ROW. I'm skeptical that Gold will do a secondary with the new information from FDA in hand. This is a balance of actual stability shift. Dendreon now has some negotiating leverage.

(3) Novecea -- a basically nothing enterprise by comparison -- garnered close to $500 million (basis benchmarks); thus Dendreon commanding at least that much for a treatment that appears to be on the order of one year away [at most] will be easy.

(4) Although Gold was very diplomatic in how he positioned his comment, he as much as said that Provenge would already be approved save for the political dynamics inside of the FDA. That means that pressure can and must be brought there and in Congress to accelerate this timetable. If anything, more pressure than ever must be brought to bear inside the beltway now and in the future.

(5) Without disclosing material non-public information, if you listened carefully, Gold pretty much acknowledged that the IMPACT study enrollment was "very similar" to 9901a. Just how the shorts expect a negative -- or somehow materially different -- outcome than 9901a with such information is a mystery.

(6) Every major Pharma now knows that they can either compete with Dendreon a year from now or own (or particpate) in the magnificent cassette technology. By jumping in now, they not only get a foothold on the PC Market but also assure themselves of a strong position for Nuvenge. In fact, by moving in sooner rather than later, any partner/suitor stands to gain materially to their pipeline because they have the capital to restart Nuvenge.

(7) The shorts now know this. The analysts are in the process of putting all of this together.

(8) If it wasn't for FTD shares and other naked tricks, the stock would already be at $18 today. You don't really think there have been 97 million shares actually "sold" today do you?

(9) Gold gives us all a summer vacation of sorts when Dendreon announces some kind of transaction at or before ASCO.

(10) The shorts capitulate and have to move on; trying to wreck another perfectly good company; but not this one.


Stay long

[GuHu1]

- approval in 2010 /2011 soll es dann doch nicht sein, wurde ja
nach dem 09.05. immer heraufbeschworen.
- Die prognostizierten $1 - $1,50 ( Cramer bzw. der poster hier
mit C ) sollten wir auch nicht sehen ( meine persönliche
einschätzung ).
- soweit ich das verstehe ( bin kein statistiker oder mediziner )
sind die kriterien zum erreichen des endpunktes auch "lockerer"
CH, deine meinung
- der rest ist meine persönliche spekulation

Dendreon Announces FDA Confirms Data Required for Provenge(R) Licensure

- Bank of America Company Presentation Available Via Webcast at 10:00 a.m. PT Today -

SEATTLE, May 31, 2007 - Dendreon Corporation (Nasdaq: DNDN) today announced the Company has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to amend the Biologics License Application (BLA) for PROVENGE (sipuleucel-T). This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.

"The FDA indicated that either a positive interim or final analysis of survival, as described in the IMPACT Special Protocol Assessment Agreement, would address their request for the submission of additional clinical data in support of our efficacy claim," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We anticipate completing enrollment in the IMPACT study this year and anticipate interim survival results in 2008. We are committed to making PROVENGE available as rapidly as possible to help the many men with late-stage prostate cancer who currently have few appealing treatment options."

Financial Outlook

Management will present an operational update and financial guidance today at the Bank of America 2007 Health Care Conference at The Four Seasons, Las Vegas at 10:00 a.m. Pacific Time. The presentation will be audio webcast live and available for replay from Dendreon's website, www.dendreon.com. The replay of the presentation will be available for 90 days.

The Company anticipates net cash utilized for operating and capital expenditures for 2007 of approximately $95 million. The Company anticipates spending levels to decrease substantially in 2008 to approximately $55 million because it has already incurred many of the third-party costs necessary to prepare for the commercialization of PROVENGE. These costs include items such as third party clinical trial costs, inventory purchases, capital expenditures related to New Jersey manufacturing and other outside infrastructure costs.

PROVENGE Biologics License Application

Dendreon's BLA was submitted under a Fast Track designation and was accepted for filing by the FDA in January 2007. The BLA was based primarily on a multi-center, randomized, double-blind, placebo-controlled Phase 3 study (D9901) that showed that the group of men with asymptomatic, metastatic, androgen-independent prostate cancer who received PROVENGE had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received PROVENGE, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving PROVENGE were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo.

Treatment with PROVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion.

IMPACT Clinical Study

IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment), also known as D9902B, is an ongoing Phase 3 clinical trial measuring overall survival in men with hormone-refractory prostate cancer receiving PROVENGE versus those receiving placebo.

In order to be eligible to participate in the IMPACT study, a person must meet certain criteria, such as having cancer that has spread outside the prostate (metastatic) or cancer that has worsened while on hormone therapy among other additional criteria. Interested patients should contact the Dendreon Prostate Cancer Information line at 1-866-4PROSTATE (1-866-477-6782).

[surga]

Antwort auf Beitrag Nr.: 29.564.166 von GuHu1 am 31.05.07 21:22:14

CNBC VIDEO
nur mit Microsoft Internet Explorer

FDA Accepts Dendreon Drug Study

http://www.cnbc.com/id/15840232?video=349928739

[GuHu1]

Antwort auf Beitrag Nr.: 29.564.361 von surga am 31.05.07 21:35:37

danke surga fürs reinstellen.

denke das ist eher ein situationsbericht.
ich fände es toll wenn CH die ergebnisse des heutigen tages für uns einmal fachmänisch äääh fachfraulich oder wie, egal, zusammenstellt.

wer es nicht hören will, mein tipp = ignorieren

[NoSelters]

Antwort auf Beitrag Nr.: 29.564.166 von GuHu1 am 31.05.07 21:22:14

Das Spannende daran ist doch,daß die FDA jederzeit,...je nach Fortschritt bzw. weiterem Erfolg der "interim trial data",die Studie abbrechen und die volle Zulassung erteilen kann !

Also alle "Steuerfunktionen" noch intakt,aber mit klarem Signal an alle "Feinde" von DNDN: Provenge wird zugelassen!

Wer den Startschuss für die FDA abgibt und wann das sein wird ist derzeit noch Spekulation.

Aber wie sagst Du immer...

Die Hoffnung stirbt zuletzt..

In diesem Sinne...

Grüsse aus dem tiefen Süden.

No

[surga]

Antwort auf Beitrag Nr.: 29.564.821 von GuHu1 am 31.05.07 22:03:54

Klar, finde ich auch! Es wäre schön, wenn CH wieder dabei ist

[GuHu1]

Antwort auf Beitrag Nr.: 29.564.915 von NoSelters am 31.05.07 22:08:19

dann setz ich mal das posting von ford rein.
chemos, zieht euch warm an, die alten regeln gelten bald nicht mehr ( sagt ford, IV Board ).


Anyone want to comment on Joel Nowak's blog post today? /// Corleyone2004 & Fordwill1953
This is not a compromise. This is just clarificatiion. The FDA is now accepting survival. Period. This is a crucial piece of info. Sounds like Pazdur was forced to crater the stance of " only permitting immunologies based on chemo standards".

This is a watershed moment. Can't say it any better. The FDA didn't compromise. They said there's a new way to approval ... non-chemo standards are valid. I.e. surogates for survival are redundant. Survival is the pathway.

Does this improve Provenge's chances? Tremendously.

Why? Because DNDN's story all along has been "look at survival and not TTP". This has been a real blow at the biostaticians. They can't quibble about suvival as much. They can only say...he's alive.

Now that's pretty doggone sane for once! Goodness me, this is great news.

Could it be ... that we are truly back on the road to approval??? Yes, we are.

So, hang on to your hats, longs. The shorts have to convert unless all the survival data was fraudulant. But, it seems to me that'd be hard to do...after all, if you ask the patient, "are you alive? and get an answer...."

Oh well... time for all the shorts to mosey on to the next drug.

Ford

[NoSelters]

Antwort auf Beitrag Nr.: 29.565.222 von GuHu1 am 31.05.07 22:27:39

Ich dachte bisher immer daß die grossen Chemo-Konzerne das Hauptproblem sind....
Aber mittlerweile ist mir klar,daß die Immuntherapie als neuer Weg in der Krebsmedizin nicht mehr gestoppt werden kann! Und die Big Player werden ihren eigenen Weg finden um an dem Kuchen teilzuhaben.(halt etwas später als DNDN)

Aber das Fiasko der Hedgies kann man retten.....
Und genau das läuft derzeit.
Es ist schwer für mich einzusehen daß wir erst die Shorties raus lassen müssen bevor DNDN die Zulassung und somit ihren reellen Wert erhält.
Insofern ist das "diplomatische Verhalten" von M.Gold heute abend nicht unbedingt negativ zu werten.Der Mann weiss mehr als wir ....


Alles nur meine Gedanken.

[NoSelters]

Das Gehopse geht weiter...

After Hour Trading:

von $ 8,47 bis $ 12,73

[hakur]

Antwort auf Beitrag Nr.: 29.565.527 von NoSelters am 31.05.07 22:51:23

bingo

[Poppholz]

Antwort auf Beitrag Nr.: 29.565.864 von NoSelters am 31.05.07 23:20:10

wurde zu diesen Kursen auch gehandelt?

Hast Du hierzu die Mengenangaben?

Danke

[Bachalor]

Antwort auf Beitrag Nr.: 29.566.027 von Poppholz am 31.05.07 23:39:08

aktuell


http://datasvr.tradearca.com/arcadataserver/JArcaBook.php?Sy…

[hakur]

Antwort auf Beitrag Nr.: 29.565.864 von NoSelters am 31.05.07 23:20:10

@Noselters
frag mich im Moment nicht nach einem Zeitfenster,
aber der Chart sagt da kommt noch was .
schon mal was von "Kietic fluid dynamic"gehört?
Wenn ich dieser Methode trauen kann ;-) könnte es hier nochmal wild zugehen.

Außerdem haben die Shorts definitiv kapiert , dass es hier für sie gefährlich werden kann.

[GuHu1]

Antwort auf Beitrag Nr.: 29.565.995 von hakur am 31.05.07 23:35:14

endlich mal ein relativ positiver abend bei dndn.
ziehe mich jetz zurück und lasse den kurs hopsen

good night @ all

[hakur]

Antwort auf Beitrag Nr.: 29.566.052 von hakur am 31.05.07 23:42:49

"Kietic fluid dynamic"

soll heißen:"Kinetic fluid dynamic"

sorry

[GuHu1]

Antwort auf Beitrag Nr.: 29.565.864 von NoSelters am 31.05.07 23:20:10

hast du schon mal was von : "Kietic fluid dynamic" gehört?
hakur sagt da kommt noch was.

hihi wenn hakur das sagt, könnte das auch eintreffen

[hakur]

Antwort auf Beitrag Nr.: 29.566.141 von GuHu1 am 31.05.07 23:57:32

ups so defintiv wollte ich dies nicht in die Welt setzen!
Lass uns mal überraschen, bin schließlich auch nurn " Mensch"
Außerdem ist die Frage des Zeitfensters im Raum.`
Kann wirklich noch nichts dazu sagen. Bei dem Chart heute Mittag gabs kein vertun , dass da was implodiert oder eben explotiert.
Von der Heftikeit war iich sehr überrascht, wer immer den Kurs so hochgzogen hat. Die 12.50 waren ein erstes Mögliches Ziel. Hatte insgesamt mit einem anderen Kursverlauf gerechnet.
Wir haben da zwar noch ein offenes Down Gap , aber wenn ich mir das heute so angeschaut habe kann es sein dass man bei dieser Geschwindikeit die da vorgelegt wurde keinen Fuß in die Tür bekommt.
Sollte scherzhaft darstellen , dass gar nichts klar ist
Aber ne Ahnung gibts

[NoSelters]

Antwort auf Beitrag Nr.: 29.566.027 von Poppholz am 31.05.07 23:39:08

Guten Morgen allerseits.

@ Poppholz:

Volumen über 1 Mio. !!

http://quotes.nasdaq.com/aspxcontent/ExtendedTradingTrades.a…

Hoffe der Link funzt.

Gruss No

[NoSelters]

Antwort auf Beitrag Nr.: 29.566.052 von hakur am 31.05.07 23:42:49

Hallo Hakur,

bin leider kein Charttechniker und deshalb über Deine Beiträge und Charts sehr froh!!

Weiter so.

Es wird/ist auf jeden Fall extrem spannend und die nächsten Tage und Wochen werden meine Ränder unter den Augen sicher nicht besser...

NoSelters

[Poppholz]

Antwort auf Beitrag Nr.: 29.567.440 von NoSelters am 01.06.07 08:58:59

vielen Dank.

Ja, funzt.

Den kann ich auch für diverse andere Kurse abfragen.

Sehr schön.

[Bachalor]

usa 8.84 zu 9.45

seht ihr an meinem link von gestern

kann auf arbeit nicht kopieren

[Poppholz]

Antwort auf Beitrag Nr.: 29.570.551 von Bachalor am 01.06.07 11:38:38

aktuell pendeln wir um die $9,00

[surga]

Antwort auf Beitrag Nr.: 29.564.361 von surga am 31.05.07 21:35:37

wieder CNBC VIDEO von gestern
nur mit Microsoft Internet Explorer

http://www.cnbc.com/id/15840232?video=350491501

[Bachalor]

haben sie schnell unter 8 noch welche kasiert

jetzt aber hurtig nach norden

[ditzeroni]

Tach zusammen

Ich weiß nicht ob sich noch einer an mich erinnert, hab hier ab und zu mal was geschrieben vor einiger Zeit.
Hab den Thread hier lange nicht mehr verfolgt, weil mir einfach die Zeit dazu fehlt und ich bei IV und I-Hub drin bin, das reicht an sich.
Ich flieg gleich los nach Seattle und werde mir da am Mittwoch das ASM antun, ebenso die Meet&Greet-Veranstaltung vom IV-Management am Dienstagabend.
Ich wollte nur mal vorab fragen ob es einen interessiert wie es da gelaufen ist, dann werde ich evtl einen kurzen Berich schreiben und den hier posten, wenn die Zeit es zulässt.
Daher frag ich lieber vorher nach, weil wenn es nämlich keinen interessiert kann ich mir die Arbeit ja auch sparen

Ich werd nächste Woche mal checken ob´s jemandwas dazu zu sagen hat, wenn ich da ins Netz komme im Hotel.

Schönen Gruß und gute Geschäfte weiterhin,

ditzbert

(OT ps: evtl mal an Silber denken)

[GuHu1]

Antwort auf Beitrag Nr.: 29.576.771 von ditzeroni am 01.06.07 16:54:26

ich erinnere mich sehr gur an dich
ich fände es toll wenn du einen kleinen bericht anfertigen würdest.
viel spass auf deinem trip

[GuHu1]

naja gerüchte ebend ( IV board ):

Re: Rumor on JAGnotes

This is cut and pasted

JAGfn Rumors
9:47 AM ET - JagNotes (Unrestricted)
(DNDN) Rumor that DENDREON CORP COM (DNDN) will reveal a partnership with a major drug company.

[edelupolino]

Antwort auf Beitrag Nr.: 29.576.771 von ditzeroni am 01.06.07 16:54:26

bin derselben meinung;
ein kleiner bericht würd bestimmt erhellend wirken!
Gruß Ede

[NoSelters]

Antwort auf Beitrag Nr.: 29.576.771 von ditzeroni am 01.06.07 16:54:26

Ich darf mich anschließen....jede Info,noch dazu aus erster Hand,ist in diesen Zeiten spannend.

Freu mich auf Deinen Bericht!!

NoSelters

[GuHu1]

aus den Yahoo board:
yep, warten wier es mal ab.

Dendreon will soon sign a major partnership deal for Provenge. They are waiting for the FDA meeting to determine if the FDA will allow Provenge back sooner rather than later.

If sooner, they sign an international only partnership. If later, they sign the major world-wide partnership agreement including the U.S. market.

Dendreon will also look to file Provenge overseas and will not wait for the FDA.

Anyway you slice it, DNDN is going to gap up in the next few weeks or months. It either jumps in a few weeks on better than expected FDA news, or, it jumps a couple of months later on the signing of an FDA partnership.

I look for the stock to rally into these anticipated near term events. Who wants to be outside looking in when the news comes?

[GuHu1]

ja, ja, die gerüchteküche

http://www.cboe.com/tradtool/webcast.aspx

[GuHu1]

1. bloomberg berichtet, ist klar, Arnie macht welle:

http://www.bloomberg.com/apps/news?pid=conewsstory&refer=con…

2.schließe mich der folgenden meinung an ( IV Board )
Thank you
thank you guys for the efforts today, Loptops, Christian, Nicole, Ammass, Cliffhucker, and others who helped at the rally, you are great people.

3.news aus dem IV Board, sehr interresant:

OHSU Cancer Institute shows findings of immunotherapy vaccine in prostate cancer patients

PORTLAND, Ore. -- Data from an ongoing study designed to explore the biologic and clinical activity of cancer immunotherapy sipuleucel-T, or Provenge, in patients with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but who have not yet developed metastatic disease will be presented by Oregon Health & Science University Cancer Institute researchers.

The study showed that sipuleucel-T did not significantly delay the time it took for a patient's PSA to reach a value of 3 ng/ml, the primary endpoint of the study, but it did show a prolongation in prostate-specific antigen doubling time (PSADT). In addition, there was a trend observed in slowing the time to metastatic disease for patients who received sipuleucel-T compared with those who received placebo, but this early trend did not reach statistical significance. The findings will be presented Saturday, June 2, at 8 a.m. (CDT) at the 43rd Annual Meeting of the American Society of Clinical Oncologists (ASCO) in Chicago.

"While there was no delay in the time to PSA recurrence, we did observe a slowing in the rate of rise of serum PSA in exploratory analyses. Additional follow-up is needed to determine if this effect on PSA will translate into patient benefits," said Tomasz Beer, M.D., lead investigator, director of the Prostate Cancer Research program at the OHSU Cancer Institute; and associate professor of medicine, (hematology/medical oncology) OHSU School of Medicine.

The ongoing trial, known as P-11, is a double-blind, multi-center, randomized, placebo-controlled study involving 176 men, all of whom had prostatectomies and then had recurrent cancer as detected by a rise in the serum tumor marker, PSA. After three months of hormone therapy, 117 men received sipuleucel-T and 59 received placebo.

Sipuleucel-T was found to have a favorable safety profile. The most common side effects seen more commonly in sipuleucel-T-treated patients were fatigue, chills and fever.

The effects of sipuleucel-T on prostate cancer progression were analyzed in several ways using measurements of serum PSA. The primary analysis focused on time until the PSA reaches 3.0 ng/ml. Although there was a trend, the immunotherapy did not significantly delay cancer progression by this measure. However, investigators found the rate at which PSA was rising was 30 percent to 48 percent slower in patients who received sipuleucel-T compared to those who received placebo.

After patients' PSAs reached 3.0 ng/ml, they became eligible for one booster infusion of either sipuleucel-T or placebo in accordance with the treatment arm to which they were randomized. An immune monitoring protocol performed in a subset of patients demonstrated that the immune response elicited by sipuleucel-T was long-lived and still strong just prior to the booster infusion, which occurred an average of 21 months following initial treatment with the immune stimulating agent. Following a booster infusion of sipuleucel-T, patients demonstrated an immune response approximately 10- to 100-fold higher than measured in placebo arm patients.
Sipuleucel-T is manufactured by Dendreon Corporation. An FDA advisory committee recently supported the safety and effectiveness for the use of sipuleucel-T in men with metastatic, androgen- independent prostate cancer (a different and more advanced patient population than those observed in this study). The FDA has delayed the approval of sipuleucel-T until more clinical data are available from an ongoing study, known as IMPACT. If approved, sipuleucel-T would be the first FDA-approved treatment designed to train the body's own immune system to fight cancer.

Prostate cancer is the most common nonskin cancer in the United States and the third most common cancer worldwide. More than 1 million men in the United States have prostate cancer, with an estimated 218,890 new cases expected to be diagnosed in 2007, and more than 27,000 men expected to die this year from the disease.
###

The OHSU Cancer Institute is the only National Cancer Institute-designated center between Sacramento and Seattle. It comprises some 120 clinical researchers, basic scientists and population scientists who work together to translate scientific discoveries into longer and better lives for Oregon's cancer patients. In the lab, basic scientists examine cancer cells and normal cells to uncover molecular abnormalities that cause the disease. This basic science informs more than 200 clinical trials conducted at the OHSU Cancer Institute.

[NoSelters]

Antwort auf Beitrag Nr.: 29.601.243 von GuHu1 am 02.06.07 22:38:35

Du kommst wohl auch nicht mehr von der Kiste weg


Chicago wahr wohl erfolgreich.

6 Interwies mit Teilnehmern sollen wohl 10 Uhr auf nem Sender kommen....hmmmh..

Radio..?...TV..?

Konntest Du mehr erfahren??

Und die News bezüglich der Booster Infusion mit 10 bis 100-facher Immunreaktion gegenüber Placebopatienten...!!
HAMMER...ODER ?

Es sieht verdammt gut aus...Meine Meinung!

Montag wird spannend.

Gruss

NoSelters



P.S @ hakur: Scheint wirklich noch was grosses zu kommen...Respekt!

[NoSelters]

Soeben von AMASS eingetroffen---Er war dabei in Chicago

WE did GOOD today
We had several interviews : Bloomberg, Chicago Tribune, Forbes and ABC Channel 7,before being tossed out of McCormock Place.(which will be on News tonight at 10cst).

[GuHu1]

Antwort auf Beitrag Nr.: 29.602.270 von NoSelters am 03.06.07 00:39:34

lies mal deine bordmail

[GuHu1]

Antwort auf Beitrag Nr.: 29.602.241 von NoSelters am 03.06.07 00:35:19

bericht über die rally auf chanel 7, 10 chicago time:

http://abclocal.go.com/wls/front

[NoSelters]

Antwort auf Beitrag Nr.: 29.602.270 von NoSelters am 03.06.07 00:39:34

+M

AMMASS

Wenn der Krieg um Dendreon gewonnen wird ,...ist es Männern wie Ihm zu verdanken!

Hut ab...

[NoSelters]

Antwort auf Beitrag Nr.: 29.602.317 von GuHu1 am 03.06.07 00:46:42

Sorry...was das angeht bin ich blind

Hatte es nicht gesehen.

Von der Strategie her bleib ich auf jeden Fall bis 20.03.2008(Steuerfreiheit) drin....Ohne wenn und aber.

Und das Achterbahnfahren bin ich ja gewöhnt...

Danke !!!

No

[GuHu1]

Antwort auf Beitrag Nr.: 29.602.356 von NoSelters am 03.06.07 00:52:53

doppel yeb

[NoSelters]

Antwort auf Beitrag Nr.: 29.602.409 von GuHu1 am 03.06.07 01:00:48

Oh Mann,...kann man das irgendwie mit nem akustischen Signal oder Hammer koppeln

[GuHu1]

ansichten aus dem IV Board:
ich habe mich bisher dazu zurückgehalten, aber das häuft sich mittlerweile. wenn das mal nicht einen schneeballeffekt auslöst?!

Dr. Scher has received grant or research support from AstraZeneca, BZL Biologics, Bristol-Myers Squibb, Novartis Pharmaceuticals, and Millennium Pharmaceuticals. He has acted as a consultant for Bristol-Myers Squibb, Conforma Therapeutics, ProQuest Investments, and Wyeth-Ayerst Pharmaceuticals. He is a member of the Speaker's Bureau for AstraZeneca and is a major stock or investment holder in Eli Lilly (stock), Cell Therapeutics (stock), Vidamed (stock), ProQuest (options), Conforma (options), and Genta (options). Dr. Scher has received other financial material support from CaP CURE.

http://www3.interscience.wiley.com/cgi-bin/abstract/10252697…

[hakur]

Antwort auf Beitrag Nr.: 29.602.407 von NoSelters am 03.06.07 01:00:31

habs im IV schon am Freitag Nacht geschrieben
fasten seatbelts.

[GuHu1]

http://www.cancercommentary.com/2007/06/03/provenge%c2%ae-si…

[GuHu1]

ich kann mir nicht vorstellen das da was dran ist.
setze es trotzdem mal hier rein.

aus dem Yahoo Board:

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

[edelupolino]

Antwort auf Beitrag Nr.: 29.602.356 von NoSelters am 03.06.07 00:52:53

AMASS ist wie der Billy Talent -sänger , der den slogan auf seiner brust hat

NEVER GIVE UP


so müssen auch wir denken...

Ede

[edelupolino]

Antwort auf Beitrag Nr.: 29.602.458 von GuHu1 am 03.06.07 01:08:26

ahaaaaaaaaaaaaaaaaaa!!!

Was wir schon immer wussten: amerika und die reine gier der WESTMÄNNER,die für gold ihre seele verkauften und ganze stämme ausgerottet haben........
...jetzt wollten sie dndn ausradieren.....

mal sehen, obs klappt!!!

[edelupolino]

Antwort auf Beitrag Nr.: 29.616.256 von GuHu1 am 03.06.07 18:21:17

wär ne irre sache!!

[GuHu1]

Antwort auf Beitrag Nr.: 29.616.256 von GuHu1 am 03.06.07 18:21:17

wie schon von mir vermutet, nur ne hohle nuss.
die meldung ist eher ne ente, bzw. eher ein wunsch.

also das partnergehabe nach hinten schieben, vorläufig jedenfalls.

good night.

[Tarnkappen-Joe]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[hri]

AP
Ahead of the Bell: Provenge Protest
Monday June 4, 6:20 am ET
Advocacy Group to Rally for Faster FDA Approval of Dendreon's Provenge


NEW YORK (AP) -- An advocacy group urging the Food and Drug Administration to approve Dendreon Corp.'s prostate cancer drug Provenge said it will rally in Washington Monday.
The group is rallying against the FDA's decision to postpone the approval process of the drug as it awaits more information on its chemistry, manufacturing process and effectiveness.

ADVERTISEMENT


The group ProvengeNow did not say how many protesters were expected at the rally, scheduled to take place in Upper Senate Park in Washington, D.C.

Last month, the FDA requested more clinical data on the drug candidate, sending Dendreon shares into freefall. The Seattle biotech's shares lost 64.3 percent of their value on May 9 after the agency requested the details.

The fall came about six weeks after the stock more than doubled in one day. Shares shot up March 30, after an FDA advisory committee agreed 17 to 0 that the data submitted by Dendreon showed Provenge was safe, and voted 13 to 4 the drug was effective.

Provenge is designed to help a man's immune system recognize the antigen in prostate cancer cells and then attack and destroy those cells. The drug is an immunotherapy, which boosts and assists the immune system, as opposed to chemotherapy, which has detrimental side effects.

Studies showed the drug increased the life of a patient with prostate cancer by an average of 4.5 months. The study also showed there was a 41 percent overall reduction in the risk of death and 34 percent of patients were alive 36 months after treatment.

ProvengeNow, on its Web site, said the drug is the first of its kind for prostate cancer and can effectively fight the cancer without the quality-of-life side effects of other treatments like chemotherapy.

[hri]

Press Release Source: Dendreon Corporation


Dendreon Corporation Announces Proposed $75 Million Convertible Senior Subordinated Notes Offering
Monday June 4, 7:00 am ET


SEATTLE, June 4 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced the Company intends to offer, subject to market conditions and other factors, $75 million aggregate principal amount of convertible senior subordinated notes due 2014. This offering will be made through a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933.
ADVERTISEMENT


The interest rate, terms of conversion, offering price, registration rights and other terms of the notes will be determined by negotiations between the Company and the initial purchaser of the notes. The Company expects to grant the initial purchaser of the notes a 30-day overallotment option to purchase up to an additional $25 million aggregate principal amount of the notes.

The Company intends to use the net proceeds of this offering to finance its activities relating to the potential commercialization of Provenge® (sipuleucel-T), expand its manufacturing facilities for the commercial production of PROVENGE, fund ongoing and new clinical trials for PROVENGE and its other product candidates, support research and preclinical development activities for its other potential product candidates, and for general corporate purposes, including working capital.

The notes and common stock issuable upon conversion of the notes have not been registered under the Securities Act of 1933 or applicable state securities laws, and unless so registered, may not be offered or sold in the United States or to U.S. persons except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act of 1933 and applicable state securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.

[Bachalor]

rt 8.02

[Bachalor]

[Bachalor]

was ist da los
volumen auch sehr stark

[brokerrene]

Vergesst nicht euch anzuschnallen!!!

[GuHu1]

ansichten aus dem IV Board:


Bond offering VERY GOOD NEWS
What the hell are you talking about?
How in the world can you short a bond, while being a bond holder yourself?
what a bull shit.

What DNDN has done is very smart. They have issued or will issue the notes.
This is just like convertible bonds, due in 2014. I used to sell annuities based on the return of thses type of bonds.
the buyer will have to hold on to it until 2014 otherwise they do not get a single share of the stock. The only way the conversion can work is if the stock goes higher form the negotiated price. Furthermore, they are buying the vision and the story of DNDN with cash without diluting the shares until 2014.
Usually the interest rate for these kind of notes or bonds are not high, because of the conversion option. Had DNDN borrowed the money from a bank
they would have to pay a higher interest rate.
This is the best news that i have heard, meaning that someone is going to buy the I.O.U. of DNDN and pay cash in return.
These bonds can not be called(not callable), and another good news is if the company had issued more shares it would have been shorted by wall street.
In fact they would have created 10 times the amount of fake shorts.
This offering will prevent that from happening.
Very Bullish sign for the stock.

[GuHu1]

diskussion auf cnbc über zulassungen durch fda ( fast track).


http://www.cnbc.com/id/15840232?video=356857952&play=1

[[KERN]Codex]

[Gefriertruhe]

Ich bin wieder drin !

Erwarte für morgen eine technische Gegenreaktion.

[EGEM]

Antwort auf Beitrag Nr.: 29.635.452 von [KERN]Codex am 04.06.07 20:10:14

[hakur]

war gestern abend in ABC NEWS, nach CNN einer der größten Nachrichtensender

http://video.google.com/videoplay?docid=5434104454122322927&…

[GuHu1]

http://www.philly.com/inquirer/front_page/20070605_FDA_criti…

[hri]

conflict of interest filings 4-Jun-07 05:26 pm links to 3 conflict of interest filings with the FDA for the Provenge panel - don't know how the 3rd voted but I can guess! (look at the 4th link - he works with/for(?) Hussain at U of Michigan)


http://www.fda.gov/ohrms/dockets/ac/07/w...

http://www.fda.gov/ohrms/dockets/ac/07/w...

http://www.fda.gov/ohrms/dockets/ac/07/w...

http://www.pubmedcentral.nih.gov/article...

[Fire2]

was ist hier los


rt 8.84$

[GuHu1]

Antwort auf Beitrag Nr.: 29.653.015 von Fire2 am 05.06.07 19:44:48

IV Board:

Re: What we saw going on just now at 8.50 /// Rush2X
Rush:

Short-term PPS burst also attributable to rumor making the rounds that a major announcment may [emphasis added -- I know zero] come out of the ASM tonight

[Fire2]

hat mal bitte jemand solch einen rt chart mit stückzahlen

hier gehen sehr große blöcke übern tisch

[hri]

Antwort auf Beitrag Nr.: 29.653.015 von Fire2 am 05.06.07 19:44:48

da liegt wieder ne news in der luft !

[Fire2]

hat bitte mal jemand rt frankfurt und ask
wenn möglich auch stücke imask

[GuHu1]

was wird uns da jetzt noch erwrten.

[Fire2]

Antwort auf Beitrag Nr.: 29.653.401 von GuHu1 am 05.06.07 20:02:59

ich hab nochmal


wieder teilausführung

mist wenn mal auf arbeit keine ob hat

[GuHu1]

liegt es möglicherweise auch daran?


JUNE 5th - CONGRESSIONAL STAFF BRIEFING
http://www.prostatehealthed.org/phen_Detail.php?News=641

BRIEFING INVITATION

The Prostate Health Education Network, Inc. will hold a briefing in collaboration with the Office of Congressman Edolphus “Ed” Towns, 10th Congressional District, New York, concerning “The Accelerated Need for Prostate Cancer Treatment Options.” We are pleased to invite you to this briefing.

When: June 5th, 10:00am.

Where: Rayburn Room 2247

Experts on prostate cancer will talk about new options for care for the tens of thousands of men with advanced prostate cancer. Approximately 30,000 men die from prostate cancer each year. This briefing will focus on the need for more prostate cancer treatment options, including immunotherapies.
We look forward to seeing you on Tuesday, June 5th.

[hri]

Antwort auf Beitrag Nr.: 29.653.401 von GuHu1 am 05.06.07 20:02:59

das was längst überfällig ist, eine begleitende zeitlich beschränkte zulassung neben der zusätzlichen testreihe an behandlungen. der öffentliche und politische druck auf die fda wird auch für diese herren langsam aber sicher unerträglich und wenn die bisherigen vorwürfe sich bestätigen rollen da auch köpfe !

[GuHu1]

Antwort auf Beitrag Nr.: 29.653.623 von hri am 05.06.07 20:13:02

weiss nicht ob das wirklich durch geht, aber irgendwas ist im busch!

[GuHu1]

Quelle IV Board:

http://www.investorvillage.com/smbd.asp?mb=971&mn=129549&pt=…

[Fire2]

vom th brökelt es wieder etwas ab

die 8.50 sollten halten

[hri]

die 2 trades sollten die richtung für morgen vorgeben :

06/05/07 16:00:07 8.80 8.74 8.35 100000
06/05/07 16:00:10 8.80 8.74 8.33 132000

[GuHu1]

Aus dem IV Board:

explaination for the June $40,50 Put options activities

SORRY , I DON'T UNDERSTAND WHY WOULD PEOPLE GO SO DEEP INTO THE MONEY AND PAY SO MUCH MONEY TO BUY THE PUT?

Ich auch nicht, hat jemand dafür eine pasende erklärung parat?

[Fire2]

geht wohl abwärts wenn hier so ruhig ist




1!

[GuHu1]

Antwort auf Beitrag Nr.: 29.667.584 von Fire2 am 06.06.07 15:45:14

oder die ruhe vor dem sturm, wer weiß.

[OneMillionDollarClub]

Antwort auf Beitrag Nr.: 23.495.737 von cyberhai am 18.08.06 13:56:06

....... hoffe du bist groß eingestiegen, so eine Chance kommt so schnell nicht wieder.

[hakur]

I Village

Msg: 130389 of 130397 6/6/2007 11:14:50 AM Recs: 2 Sentiment: Not Disclosed
By: ralphla54 Send PM Profile Ignore Recommend Add To Favorites
Shorts are SCREWED Bond offering placed a nail in their coffin


Shorts have no way out that I can see since the hoped for near term dilution of the stock is no longer a possibility. A stock dilution will not happen until 2010. By that time Provege will be approved. Production lines will be in place since money is now available to continue build out. Production bottle neck was a problem regardless of Approvable vrs Approval letter. The company will have enough money to ward off fake class action suite designed to bleed the company’s reserves. Between now and mid 2008 the stock will rise in anticipation.

DNDN is now in strong position to negotiate with partners. They can pursue European approval/Partner and have limited production capabilities available by then. Partner announcement will drive price above 15 and maybe to 20. Production and sales in Europe will drive it over 40.

Work can continue on other cancer treatments such as breast cancer etc.

How would you like to be setting on a time bomb like DNDN with a huge short position. I hope that the short position this month will be huge. The remaining shorts must buy their way out of this mess and this will only drive the stock higher. Arrogant short Bastards that did not get out when the stock went to 5 will regret their incompetence.

wait
and
see

[GuHu1]

Antwort auf Beitrag Nr.: 29.669.142 von hakur am 06.06.07 17:20:59

yep hakur, lets wait and see.

[mani40]

Antwort auf Beitrag Nr.: 29.669.142 von hakur am 06.06.07 17:20:59

okay ich stifte auch einen Nagel für deren Sarg

[GuHu1]

Antwort auf Beitrag Nr.: 29.673.302 von mani40 am 06.06.07 21:21:20

gut, kann aber noch ein bischen dauern.

[hakur]

Antwort auf Beitrag Nr.: 29.673.302 von mani40 am 06.06.07 21:21:20

warum so sparsam?
;-)

[GuHu1]

Antwort auf Beitrag Nr.: 29.674.241 von hakur am 06.06.07 22:08:24

hi hakur, stimmung im iv board ist derzeit zweigeteielt.
ich sehe erstmal noch keinen grund hinzuschmeißen.
man merkte aber die angespannte lage auch bei den shorts, es knistert förmlich.

IV Board:

Jun 06, 2007 (M2 PRESSWIRE via COMTEX) -- New York-AheadoftheBulls.com, announces the following companies as high potential, Future Bulls: Hybrid Technologies, Inc. (HYBT), Dendreon Corp. (DNDN) and Coastal Hldgs New (Pink Sheets: COHG)....

(later in the text)

... Dendreon Corp. (NASDAQ GM: DNDN, http://finance.yahoo.com/q?s=dndn )


Dendreon Corporation Prices $75 Million Convertible Senior Subordinated Notes Offering


June 6, 2007-- Dendreon Corporation (Nasdaq: DNDN - News) today announced the pricing of its offering of $75 million aggregate principal amount of convertible senior subordinated notes due 2014. This offering will be made through a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933. The notes will bear interest at a rate of 4.75% per year. The Company has granted the initial purchaser of the notes a 30-day overallotment option to purchase up to an additional $25 million aggregate principal amount of the notes. The sale of the notes is expected to close on June 11, 2007, subject to satisfaction of customary closing conditions. The notes are convertible into shares of Dendreon common stock at an initial conversion rate of 97.2644 shares per $1,000 principal amount of notes, equivalent to an initial conversion price of approximately $10.28, subject to adjustment. The initial conversion price represents a premium of approximately 17.5% relative to the last reported sale price of Dendreon common stock on the Nasdaq Global Market of $8.75 on June 5, 2007.


The Company intends to use the net proceeds of this offering to finance its activities relating to the potential commercialization of Provenge (sipuleucel-T), expand its manufacturing facilities for the commercial production of PROVENGE, fund ongoing and new clinical trials for PROVENGE and its other product candidates, support research and preclinical development activities for its other potential product candidates, and for general corporate purposes, including working capital.


The notes and common stock issuable upon conversion of the notes have not been registered under the Securities Act of 1933 or applicable state securities laws, and unless so registered, may not be offered or sold in the United States or to U.S. persons except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act of 1933 and applicable state securities laws.

[ossi67]

Antwort auf Beitrag Nr.: 29.674.683 von GuHu1 am 06.06.07 22:34:43

Stimmung ist wirlich im IV derzeit am Kippen.

Msg: 130753 of 130775 6/6/2007 4:26:41 PM Recs: 12 Sentiment: Not Disclosed
By: fordwill1953 Send PM Profile Ignore Recommend Add To Favorites
Posted as a reply to msg 130642 by green228

Re: Ming is right -- there's a link between Small's no-show at AC meeting and the CR letter. EOM
JMO...

1. Dr. Hershberg was the CMO Chief Medical Officer. He suddenly was pushed or jumped overboard. I went hmmmmmmmmmm. Was he in the camp of Dr. Small or not?????

2. The combined data argument of Mitch was very powerful. But, there were not enough patients (it seems) for a stand alone BLA. Mitch read the FDA regs and went over them EXTREMELY carefully and found that 2 studies if submitted where the second is supportive, that can be the basis of a BLA.

3. When Mitch met with the "FDA", he was told that a supportive study only has to show support overall and not have to have a P< 0.05 on its own. Mitch said that opened the door to the BLA in the first place. He never said who was the voice of the FDA at the time. But, most of us interpreted that to be at the manager level...perhaps Dr. Puri. (Ed. note. Supportive is in the eyes of the beholder... and yes, did they ask the right ... beholder? Obviously, they didn't because the FDA asked for more proof.)

4. When Mitch decided to use the 9902a as supportive/ndependent data, he decided to show the data as a stand alone and in combination with 9901. He publically tried to use the supportive argument with the survival stat over and over again. The P>0.32 negated the news on the street. It totally blew away any confidence that Provenge was the real deal with the biostatisticians. They to a man, lined up and said "redo". Even at the panel, the biostat guys said the data was problematic.

5. As Dr. Small was in charge of the trials, he knew that the 9902B was not ready for such a full blown test. In reality, Dr. Chris Henney never envisioned 9902B to be the decisive test to prove 9901. The early results of the Provenge studies like the Phase II showed that men with less cancer did better with Provenge. So, they thought that they'd test this and try to attract men in earlier stages of Prostate Cancer.

But, back to 2005, Henney had left Dendreon and all Mitch had in reserve was the enrollment for 9902B. Mitch knew he had to get an additional change with a SPA document and open up the trial to all gleason scores. This makes for a really troubling data set result. 9902B was set up in 2003 for men with gleason scores less than 7 that hadn't had any metasteses or bone pain. It's a tall order for a man with early prostate cancer to suddenly go into a medicine of last resort even if it is not painful. It requires the patient and doctor jumping over the wall from dealing with PCa as a chronic desease to dealing with a desease that truly lethal. 9902B did not attract men as rapidly as 9901. It was dragging on and on.

Worse, the data array would NOT be uniform throughout the test because the data could be challenged. Men who were tossed out of the early stages of the trial could be invited back to enroll. Now that is very strange. This makes for messy scientific trials. Dr. Small would bear the brunt of this by trying to keep the trial data clean. But could it truly be predictive of the overall result???

6. Magically, Mitch Gold announced that the protocal change/SPA was done. We all thought we'd get a quick fulfillment of the alotted patients. This was in 2005. We didn't hear of enrollment. To this day, we don't hear of enrollment rates.

7. Mitch Gold is NOT being nor has he ever been candid with the basic statement of progress when he fails to be candid with enrollment. To this day, he believes that these are Company secrets. To this day, he thinks that the street will sink his boat if he is forthcoming.

8. I'm not confident that the 9902B data set when it is seen as an interim in 2008 will show the significant survivorship oover placebo.. Why? BECAUSE THE EARLY PATIENTS ENROLLED WERE NOT AS SICK AS 9901. This completely negates a Mitch Gold lie of the last conference call. He said that the 9902b patient population was like 9902a. Sorry, folks, the interim will be heavily based upon the low gleason enrollees of 2004 and 2005. It is less likely they will be dying as rapidly as 9901 because they were not as sick as a whole.

This then will force the 360th death event out into the future several more months. Less sickly men do not dies as rapidly as a group.

As the touchstone goes out into the future, more provenge treated patients will progress and there will not be as much survival stats until the 30th+ month post treated.

Dr. Small sees all of this and doesn't want to be at the head of this parade.

THIS IS WHY DR. SMALL IS NOT JUMPING OUT INTO THE OPEN FOR PROVENGE. He's running the lab and the product is not attracting patients for whatever reason.

So... ask yourself this question... If everything is so hunky dory, Mitch Gold, why do you refuse to open your kimono and prove it??????

Und Ming und Fordwill sind Urgesteine im DNDN-Thread.

[hakur]

Antwort auf Beitrag Nr.: 29.674.683 von GuHu1 am 06.06.07 22:34:43

es knistert förmlich
muß kein schlechtes Zeichen sein
meine bescheidene Meinung

[GuHu1]

Meinungen dazu ?????
quelle IV Board:

6-Jun-2007

Entry into a Material Definitive Agreement



Item 1.01 Entry into a Material Definitive Agreement.
On June 5, 2007, Dendreon Corporation ("Dendreon") agreed to sell $75 million aggregate principal amount of its 4.75% Convertible Senior Subordinated Notes due 2014 (the "Notes"), pursuant to the terms of the Purchase Agreement dated as of June 5, 2007, between Dendreon and Merrill Lynch, Pierce, Fenner & Smith Incorporated (the "Initial Purchaser"), a copy of which is attached hereto as Exhibit 10.1 (the "Purchase Agreement"). The Company has granted the Initial Purchaser of the Notes a 30-day overallotment option to purchase up to an additional $25 million aggregate principal amount of the Notes. The Notes are being offered only to qualified institutional buyers in accordance with Rule 144A under the Securities Act of 1933, as amended (the "Securities Act").
The above description of the Purchase Agreement is qualified in its entirety by reference to the terms of the Purchase Agreement, attached hereto as Exhibit 10.1 and incorporated herein by reference. Item 8.01 Other Events
On June 6, 2007, Dendreon issued a press release relating to the pricing of a private offering of the Notes. Pursuant to Rule 135c under the Securities Act, a copy of the press release is attached to this report as Exhibit 99.1 and is incorporated herein by this reference.
The information contained in this Current Report on Form 8-K is neither an offer to sell nor a solicitation of an offer to buy any of the Notes. The Notes to be offered will not be registered under the Securities Act, or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits

Exhibit No. Description
10.1 Purchase Agreement, dated as of June 5, 2007, between Dendreon and the
Initial Purchaser.

99.1 Press Release of Dendreon Corporation dated June 6, 2007.

[GuHu1]

Antwort auf Beitrag Nr.: 29.675.375 von hakur am 06.06.07 23:20:11

ist es scheinbar auch nicht

[Poppholz]

Big shot of cash for Dendreon
By Angel Gonzalez
Seattle Times business reporter

In a bid to tread water pending the delayed regulatory approval of its first cancer-fighting drug, Seattle biotechnology company Dendreon said Wednesday it had raised $75 million from institutional investors.

The company said it may sell $25 million more in convertible debt by early July. The transaction closes Monday.

That "gives us two years worth of cash," Chief Financial Officer Gregory Schiffman told shareholders at the company's annual meeting Wednesday. "We've removed the financial overhang from the company."

The move follows the U.S. Food and Drug Administration's decision to hold off approving Dendreon's prostate-cancer drug therapy, Provenge, originally expected to be marketed this year.

Despite an FDA advisory board recommending approval, the agency requested additional clinical results proving the drug's effectiveness in stopping the spread of prostate cancer and extending patient lives.

That data won't be available until at least next year, forcing Dendreon to put its fast-moving commercialization plans on hold and to cut its work force by 18 percent.

Dendreon's fund-raising effort underscores how small biotech firms struggle to stay afloat even as they jump through the hoops of a strict regulatory examination that can take years.

The process can take its toll not only on shareholders seeking to profit from the $1 billion market in therapies for prostate cancer, but also on patients who pin their hopes for survival on a miracle breakthrough.

Emotions can ride high. Two doctors on the advisory panel who opposed approval of Dendreon's drug received e-mail threats, The New York Times reported earlier in the week.

Provenge belongs to a new class of bio-engineered drugs that spur the immune system to destroy malignant tumors.

Dendreon, like many biotech companies waiting to sell their first scientific breakthroughs, has no income from its products.

At the end of the first quarter, the company had $88.5 million in cash and investments.

With anticipated capital expenditures of $95 million for 2007, it was on track to end the year with only $25 million, said David Miller, president of Biotech Stock Research, a Seattle-based research firm.

"This just gives them some more wiggling room" until the interim clinical data is available, Miller said.

The choice of selling convertible notes instead of new shares was smart, because selling more stock at the current price would dilute existing shareholders' stake, Miller said.

Dendreon stock has had some wild swings in recent months. Shares skyrocketed when the FDA advisory panel recommended approval in late March, only to tank as the agency withheld its final blessing in May.

Shares rose again when regulators confirmed they would make a decision on interim data from a clinical study that may be available next year.

"It's been an incredibly interesting 2007 for the company," Chief Executive Mitchell Gold told a couple hundred shareholders at the meeting at Dendreon's downtown Seattle offices.

Some investors expressed frustration at the FDA's reluctance to approve Provenge, and the ensuing roller-coaster ride in share prices.

"I was a millionaire one day, and then we got shot down," said Arnie Mass, 71, a retired broker from Chicago who said he helped stage a demonstration in favor of Provenge's approval at a biotech conference there last weekend. "But I still hope."

Angel Gonzalez: 206-515-5644 or [e-mail]

Copyright © 2007 The Seattle Times Company

E-mail article Print view
More business

http://seattletimes.nwsource.com/html/businesstechnology/200…

[Poppholz]

Law Firm Of Schiffrin Barroway Topaz & Kessler Files Class Action Lawsuit Against Dendreon On Behalf Of Shareholders - Quick Facts [DNDN]

6/6/2007 9:12:06 PM The law firm of Schiffrin Barroway Topaz & Kessler, LLP said that it filed a class action lawsuit in the United States District Court for the Western District of Washington on behalf of all common stock purchasers of Dendreon Corp. (DNDN) from March 30, 2007 to May 8, 2007, inclusive. The Complaint charges Dendreon and certain of its officers and directors with violations of the Securities Exchange Act of 1934.

The complaint alleges that the company failed to disclose and misrepresented material adverse facts that were known to defendants or recklessly disregarded by them. These include the FDA's determination that the Company's BLA could come earlier than the highly touted May 15, 2007 date, that study D9902A was not a complete clinical trial due to the limited number of enrolled patients and therefore lacked complete statistical significance, and that as a result of the foregoing, study D9902A was not comparable to earlier studies. In addition, the complaint alleges that the company's studies failed to show that Provenge slowed the spread of prostate cancer; that the company had significantly changed how it categorized a contract with Diosynth for commercial scale quantities of antigen in its financial statements, and that the change in accounting allowed the company to manipulate its financial statements, thereby making the company appear financially stronger and more attractive to investors.

http://www.rttnews.com/sp/breakingnews.asp?date=6/7/2007&ite…

[Fire2]

[GuHu1]

Antwort auf Beitrag Nr.: 29.681.537 von Poppholz am 07.06.07 11:36:25

is nicht schön, sagt aber erst mal noch nicht viel aus.

[GuHu1]

http://tinyurl.com/26org7

[Fire2]

dow und nas kacken zur zeit richtig ab

[GuHu1]

aha

We are seeking a Director of Quality Control to lead and coordinate quality control team, providing strategic and operational leadership in Quality Control operations to move our products from development to commercialization, including enterprise wide projects and stability projects. Manage departmental planning/scheduling, budget development and oversight, resource management, and staff mentoring. Provide vendor management and project operational support, including method validation and method transfer.

[GuHu1]

Antwort auf Beitrag Nr.: 29.693.436 von GuHu1 am 07.06.07 20:47:17

sorry der link

http://www.resourcehire.com/clients/Dendreon/publicjobs/

[Poppholz]

Antwort auf Beitrag Nr.: 29.691.878 von GuHu1 am 07.06.07 19:08:54

daher habe ich die Info auch Kommentarlos hier eingestellt.

[GuHu1]

Antwort auf Beitrag Nr.: 29.692.686 von Fire2 am 07.06.07 20:02:12

dow und nas kacken zur zeit richtig ab

lass sie kacken, nas. - 1,77% und dndn leicht im plus.

[Fire2]

Antwort auf Beitrag Nr.: 29.695.213 von GuHu1 am 07.06.07 22:51:36

und die 8 hat auch gehalten
rechne mit anstieg die nächsten tage

[hakur]

schaut euch mal den chart von NOVACEA, INC. ( Novc) an.
Scheint so dass da ein Bull Keil am entstehen ist.
Meines Wissens ist NOVACEA, INC. ein Wettbewerber von Dndn.
Spekulationen sind ja erlaubt in diesem Geschäft.

[julevernes]

morgen wird sie von frick in n24 vorgestellt ...

[GuHu1]

Antwort auf Beitrag Nr.: 29.702.158 von julevernes am 08.06.07 11:58:59

das treibt den kurs möglicherweise in D kurz an,
mehr aber auch nicht.

erlicherweise muss ich sagen, wenn MF etwas empfiehlt ist vorsicht geboten. Da ich das hier aber schon länger als MF beobachte ( bzw. invetsiert bin ), fällt mir dazu nur eines ein:
auch ein blindes huhn findet mal nen korn. prost

[hakur]

Antwort auf Beitrag Nr.: 29.702.158 von julevernes am 08.06.07 11:58:59

haltet bitte den frick hier raus

[hakur]

Antwort auf Beitrag Nr.: 29.702.528 von GuHu1 am 08.06.07 12:19:28

danke Dir Guhu1

[GuHu1]

Antwort auf Beitrag Nr.: 29.702.616 von hakur am 08.06.07 12:24:04

@hakur
würde mich nicht wundern wenn die made ( MF ) sich heute schon mal eingedeckt hat, siehe kursverlauf.
das musst du wohl in deiner analyse berücksichtigen, wobei das gesammt gesehen eher unwichtig ist.

[hakur]

Antwort auf Beitrag Nr.: 29.702.754 von GuHu1 am 08.06.07 12:32:12

der Typ nervt,
macht mir etwas Angst wenn ewr autaucht ;-)

unabhängig davon, die Spannung steigt mal wieder!

[ossi67]

wenn es wirklich stimmt: Teigrolle suche dir für Deine Jünger einen anderen Spielplatz

Kann es mir aber nicht wirklich vorstellen.
Ist ja kein Explorer und hier zählen ja m.E. nur die fundamentals und der Kurs an der Nasdaq

Wie will Frick da pushen !!??
Ausserdem sind seine Jünger derzeit zu Recht enorm sauer (siehe Kursverlauf Russoil, Stargold etc.) und ob die dem noch folgen, ist eher fraglich

[hakur]

könnte intersssant werden!


Msg: 131806 of 131816 6/8/2007 9:03:43 AM Recs: 5 Sentiment: Not Disclosed
By: prophet_of_profits Send PM Profile Ignore Recommend Add To Favorites
Will the SEC Finally Close the Door on Naked Shorts?
This could be big. The SEC will meet on June 13, 2007 for a final decision whether to adopt amendments to RegSho that will effectively CLOSE THE DOOR ON NAKED SHORTING PERMANENTLY. Currently miscreates can hide behind the "Option Market Maker Exemption" to maintain naked short positions indefinitely, even when a naked shorting positions exceeds RegSho thresholds. If adopted this amendment will permanently close this loop hole.

AMEN!

In addition to DNDN, check the price action in OSTK and HSOA (and other heavily naked shorted shares) to see whether WS believes that the rules will change. I doubt, you know, follow-the-money.


http://sec.gov/news/openmeetings/2007/ssamtg061207.htm



The subject matter of the Open Meeting scheduled for Wednesday, June 13, 2007 at 10:00 a.m. will be:

1. The Commission will consider whether to adopt amendments to the grandfather provision of Rule 203 of Regulation SHO and the market decline limitation of Rule 200(e)(3).

2. The Commission will consider whether to re-propose amendments to the options market maker exception to the close-out requirement of Regulation SHO and the marking requirements of Rule 200(g) of Regulation SHO.

3. The Commission will consider whether to adopt amendments to the short sale price test of Rule 10a-1. In addition, the Commission will consider whether to adopt an amendment to the "short exempt" marking requirement of Regulation SHO.

4. The Commission will consider whether to adopt amendments to Rule 105 of Regulation M that would further safeguard the integrity of the capital raising process and protect issuers from manipulative activity that can reduce issuers' offering proceeds and dilute security holder value.

[GuHu1]

Aus dem Yahoo Board:
was soll man davon jetzt halten?

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

[PaulPanzer]

Wir brauchen den Frick hier nicht.
Dendreon wird auch so steigen

schönes WE euch allen

[GuHu1]

Antwort auf Beitrag Nr.: 29.712.674 von PaulPanzer am 08.06.07 20:18:16

bei Firck stimme ich dir uneingeschränkt zu.
das mit dndn kann noch ein steiniger weg werden, sieht aber schon viel besser aus als am / kurz nach dem 09.05!

[GuHu1]

auch nicht schlecht

http://www.phillyburbs.com/pb-dyn/news/322-06072007-1359110.…

[edelupolino]

Antwort auf Beitrag Nr.: 29.714.533 von GuHu1 am 08.06.07 22:02:38

ein klasse bericht, der den (älteren) männern aus leib und seele spricht:
zitat

...Thanks to the FDA and their focus on process over the introduction of safe, innovative therapies, prostate cancer victims have been victimized twice — once by their disease, one of the most hideous cancers to strike men (especially black men) and a second time by von Eschenbach and what we now know to be his bridge to nowhere. He and his staff may think themselves good doctors and scientists, but unfortunately for cancer victims, they have forgotten the Hippocratic Oath: First, do no harm. May 9 was, indeed, Black Wednesday at the FDA and for cancer sufferers worldwide.

Theodore J. Cohen, Ph.D., Middletown, is a research scientist.

June 7, 2007 5:30 AM


leider gehts wohl wie in der großen POLITIK: mini-schritte auf niederstem niveau unter beachtung der machtansprüche der dreckslobbies...

der prosttata-kranke ist schließlich selbst schuld: wieso hat er dieses organ nicht schon frühzeitig (schlage vor mit ca 35 - oder noch sicherer- mit 30) entsorgt.....Er wär alle seine sorgen los und müsste keine briefe des jammers an die FDA schreiben.

[sigi10]

Antwort auf Beitrag Nr.: 29.748.521 von edelupolino am 09.06.07 12:15:26

hallo zusammen

habe heute in makemoney gesehen, dass frick auf eine telefonische anfrage hin die dendreon zum verkauf empfohlen hat - nur zur info

[edelupolino]

Antwort auf Beitrag Nr.: 29.749.126 von sigi10 am 09.06.07 12:59:21

frick ist ein zwerg unter den analysten,die dndn besprechen.

Er kann sagen, was er will; wenns in amerika los und nach oben geht, zerreißen ihn seine jünger.

[PaulPanzer]

Antwort auf Beitrag Nr.: 29.749.568 von edelupolino am 09.06.07 13:25:56

Das die Jünger überhaupt noch auf den Hansel hören.

Der treibt seine Jünger alle noch in den Ruin. Bestes und jüngstes Beispiel STARGOLD MINES

Was der empfiehlt, ist so viel Wert als das ein Sack Reis in China umfällt

[sunbeamer]

Eine Frage an die Experten: hat zufällig jemand diesen Newsletter abonniert und Zugriff auf den Artikel?

http://fdanews.com/newsletter/article?issueId=10291&articleI…

Wäre neugierig, was da so drinsteht...

[GuHu1]

Antwort auf Beitrag Nr.: 29.749.126 von sigi10 am 09.06.07 12:59:21

hi siggi,
danke für den hinweis.
halte nichts von dem typen deswegen weiss auch nicht was er empfielt.

[GuHu1]

Mal schaun was die beiden da so zu verkünden haben.

INFO on NASDAQ® 19th Investor Program Healthcare Forum.....
The Presentation in London will be given by:

Mr.Greg Schiffman - Sr Vice President and CFO

Tuesday, June 19 at 3:00 p.m. local time (10:00 a.m. ET)

http://investor.shareholder.com/nasdaq/June2007.cfm


Dr. Gold is scheduled to speak in Zurich the following day:

11:15-11:45 local time (5:15 a.m. ET)
Dendreon Corporation
Mitchell Gold - President and CEO

http://www.nasdaqinvestorprogram.com/agenda_wed.asp

[GuHu1]

IV Board:

Here Come the Dendreon Lawsuits

http://www.fool.com:80/investing/high-growth/2007/06/11/here…

[OneMillionDollarClub]

Antwort auf Beitrag Nr.: 29.751.755 von sunbeamer am 09.06.07 15:25:50

vielleicht von Interesse.........

Für die Experten von "Global Biotech Investing" ist die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) ein extrem spekulatives Investment. Mit ihren Kapriolen sorge die FDA in der Zulassungspolitik im Krebsbereich für Frustration und Entsetzen. Die FDA habe in einer atemberaubenden Kehrtwende Dendreon mitgeteilt, dass man eine Zulassung von Provenge auch auf der Basis von Interimsdaten zu erteilen bereit sei. Zunächst habe das Adivsory-Committee dem Krebsvakzin ausreichende Effizienz attestiert. Danach habe die Zulassungsstelle den Antrag mit dem Hinweis einkassiert, dass eine solche nicht erkennbar sei, um dann nach einer Welle wütender Proteste von Patienten und Ärzten in einer nächsten Kehrtwende bereits vorläufige Zwischendaten einer weiteren Studie b.a.W. als ausreichende Grundlage für eine Zulassung anerkennen zu wollen. Der Kurs des Titels sei das getreue Spiegelbild der Volten der FDA-Zulassungsgremien, die mit solchen Praktiken auf dem besten Weg seien, das Vertrauen der Märkte zu gefährden. Tatsache sei, dass das Therapieangebot bei Prostatakrebs bedenklich begrenzt sei und dringend neue Wirkstoffe benötigt würden. Auch die FDA könne sich dieser Einsicht nicht dauerhaft verschließen und müsse sich der Frage stellen, ob sie tatsächlich jahrelang ein als sicher erwiesenes Präparat nicht für den Markt zulassen wolle, bis die Klärung der letzten Effizienzeckpunkte erfolgt sei. Das weltweite Marktvolumen für die Behandlung von Prostatakrebs dürfte locker mehr als USD 1 Mrd. pro Jahr betragen - Off-Label-Verschreibungen gar nicht berücksichtigt - und diese Volumen seien ins Verhältnis zu setzen mit den momentanen Bewertungen von Dendreon: USD 680 Mio. Wenn Provenge zugelassen werden sollte, dann müsse die Aktie zwangsläufig ganz woanders stehen und dabei dürften die im April gesehenen Hochs von USD 25 noch nicht alles gewesen sein. Das Handicap dabei sei die doppelte Spekulation, die jetzt mit diesem Play notwendigerweise verbunden sei: Zum einen eine überzeugende Bestätigung der Testdaten und zum anderen die dann bestimmende Linie in der FDA, wo ein neuerliches Nein nach den letzten Kapriolen ebenso möglich sei wie das Gegenteil. Die Experten von "Global Biotech Investing" halten die Aktie von Dendreon für ein extrem spekulatives Investmentlleicht i

[fred4]

Antwort auf Beitrag Nr.: 29.880.587 von OneMillionDollarClub am 13.06.07 20:34:16

<Die Experten von "Global Biotech Investing" halten die Aktie von Dendreon für ein extrem spekulatives Investment....

Danke für diesen Expertentip ! ;-)

[GuHu1]

jede investition in bios ist spekulativ.
meiner bescheidenen meinung nach ist das folgende längst überfällig, nicht nur bei dndn, grundsätzlich.

June 13, 2007 11:23 ET
By Judith Burns
Of DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)--The Securities and Exchange Commission voted Wednesday to
approve a change to tighten rules intended to curb manipulative short sales,
including so-called "naked" short sales.

The change eliminates a controversial exception that shielded existing short
positions from requirements to deliver hard-to-borrow shares within 13 days of
settlement. Once the change takes effect, short positions previously protected by
the grandfather clause must be closed out within 35 days.

SEC Chairman Christopher Cox said persistent failures to deliver shares sold
short seem to be due to the grandfather protections, which the SEC included in
2004 to prevent stock-market volatility. Critics complained the protections
undermined efforts to clean up abuses involving "naked" short sales.

Short selling involves sales of borrowed securities, producing profits when
prices decline. The practice is legal, but the SEC's Regulation SHO sought to
prevent "naked" short sales, in which short sellers don't borrow securities they
sell.

SEC officials said delivery failures have declined about 35% overall since
Regulation SHO took effect and have fallen about 53% for hard-to-borrow stocks
defined as "threshold" securities.

-By Judith Burns, Dow Jones Newswires, 202-862-6692; [e-mail]
(END) Dow Jones Newswires

[surga]

Antwort auf Beitrag Nr.: 29.749.126 von sigi10 am 09.06.07 12:59:21

Millionenverluste mit Frick-Tipps

von Bettina Seidl

Die Börse ist bisweilen ein verlustträchtiges Spiel. Wer so unklug war, den Börsentipps von Markus Frick zu Star Energy, Stargold und Russoil zu folgen, hat sich eine blutige Nase geholt, wenn er nicht rechtzeitig verkauft hat. Die Anleger kochen, werfen ihm gar Betrug vor.......

http://boerse.ard.de/content.jsp?key=dokument_234202

[bernie55]

Antwort auf Beitrag Nr.: 29.937.202 von surga am 15.06.07 12:01:48

Auszug aus dem Artikel....

Der Schaden, den Anleger durch Fricks Empfehlungen erlitten haben, dürfte einen dreistelligen Millionenbetrag ausmachen. Nicht nur in Börsen-Communitys wie Wallstreet-Online kocht die Stimmung hoch. Auch in der Redaktion von boerse.ARD.de trafen zahlreiche Emails von Lesern ein, die mit Frick-Tipps viel Geld verloren haben und vermuten, dass die Weste des N24-Moderators alles andere als weiß ist.

In den Vorwürfen ist gar von Betrug die Rede. Frick soll mit den Unternehmen, die von ihm empfohlen wurden, unter einer Decke stecken und deren Aktien gegen eine stattliche Provision empfohlen haben. Frick bestreitet dies.

Inzwischen interessiert sich die Börsenaufsicht Bafin für die Vorgänge, die sie routinemäßig untersucht. Der Staatsanwaltschaft Berlin liegt eine Anzeige gegen Frick vor. Diese wird nun geprüft.



...das wäre der Bringer des Jahres 2007...

[surga]

Antwort auf Beitrag Nr.: 29.937.475 von bernie55 am 15.06.07 12:16:42

Gier frisst Hirn

[bernie55]

Antwort auf Beitrag Nr.: 29.937.532 von surga am 15.06.07 12:19:43

...Yepp......ELAN können wir da mehr vetrauen....

[surga]

Antwort auf Beitrag Nr.: 29.937.670 von bernie55 am 15.06.07 12:28:22

so is es

[Poppholz]

Antwort auf Beitrag Nr.: 29.937.670 von bernie55 am 15.06.07 12:28:22

[GuHu1]

ich weiss wohl das es bei ELAN derzeit gut läuft.
find ich auch super, bin dank birgit nähmlich auch investiert!

bei Elan braucht man nicht posten, das habt ihr sehr gut im griff!

[GuHu1]

und genau das macht es soooo interresant:

- A Deadly Dysfuntion at the FDA -

- Agency abandons 60,000 end-stage Prostate Cancer Victims to Needless Suffering and Premature Death -


FDA recently delayed, for what appears to be years, a revolutionary new treatment for end-stage Prostate Cancer called Provenge.

Provenge, produced by a small independent biotech company called Dendreon, is one of a new type of treatments termed "active immunotherapeutics", it is not a "chemo" agent, and its most serious side effects are flu-like symptoms of fever and chills lasting a few days following each of only 3 infusions.

Provenge teaches one's immune system to "recognize" their cancer, and thus mount an appropriate natural defense againts it.
It is akin to sending one's immune system to Grad School...and it keeps working for years unlike the dreaded chemotherapies.

Approximately 300,000 men in America are diagnosed with Prostate Cancer each year in America, with 27,000 dying of the disease.
The average life expectancy when one reaches the very dreaded and painful end-stage (AIPC) is only about 20 months.

Provenge demonstrated phenomenal efficacy results in its Phase 3 trials. Fully 34% of Provenge recipients were still alive at 36 months, compared to only 11% of those who received a placebo. For a cancer treatment, where progress is often measured in weeks of increased survival not months or years...this is an incredible achievement.

A number of Provenge recipients are alive and well over 6 years later! Their amazing longevity was achieved without Provenge "booster' infusions and is not properly reflected in the 'official' survival statistics as the trial ended after only 3 years. Yes, they are alive and well over 6 years later....some might consider that their "terminal" condition has become a "manageable" one.

The FDA has long recognized "Overall Survival" as the "Gold Standard" in cancer treatment. Other common trial 'end-points', such as "time to progression" (TTP) are considered surrogate markers for survival. What is of the utmost importance is does this treatment extend life and or improve one's "quality of life" without serious safety issues....is it superior to what is currently avialable? Provenge passes with Flying Colors on all counts.

The only currently FDA approved alternative treatment for AIPC is a chemotherapy of such limited efficacy (average ten-week life extension) and such severe side effects that the majority of AIPC patients simply refuse to take it...they choose death instead.

- FACTS -

On 3/29/07 an 'Advisory Committee' of FDA appointed experts convened to review Provenge.

The Committee voted unanimously, 17-0, that Provenge was SAFE!

The Committee voted 13-4 that Provenge demonstrated "Substantial Evidence" of efficacy, which is the legal standard for approval per FDA regulations.

On 5/9/07 the FDA's CBER division overruled their own Advisory Committee and denied approval of Provenge! WHY???

**Interestingly, the 2 Committee members who argued most stridently against Provenge efficacy had signed "conflict of interest" statements, were granted waivers, and then allowed to sit in review of Provenge in spite of their potential bias.

Former FDA Deputy Director Dr. Scott Gottlieb, now with the American Enterprise Institute, has stated recently in an interview with Paul Gigot, that Provenge should have been approved.

Exactly whose interests are being served when the FDA overrules their own panel of experts and withholds a safe and superior treatment from terminal patients with no acceptable alternative?

Whose ox is likely to be gored by the approval of the first active immunotherapeutic cancer vaccine?

Maybe some enterprising investigative reoporter needs to Follow The Money!

If you who read this information are outraged, pick up your phone and call your Representative, call your Senators, and demand a Congressional Investigation of the FDA. Don't stop and don't take "no" for an answer. FDA Commissioner Andrew von Eschenbach must be held accountable for the actions of the CBER division of FDA who handed down this unconscionable decision.

Do it for the 27,000 who will suffer and die prematurely each year that Provenge is delayed. The life you save may be your own or that of a loved family member, dear co-worker, friend or neighbor.

For further information, or advice on how to get involved in this effort to make Provenge Available Now, go to the ProvengeNow site http://www.provengenow.org/, or contact Frank Burroughs at Abigail Alliance http://abigail-alliance.org/.

Prostate cancer patients, their family members, activists, investors, and health care professionals paid for the placement of this ad.

[GuHu1]

gute frage wie ich finde, who knows, wie ich meine.

Why does it seems like Fobes, which in the past has released many articles (All negative, bad press on DNDN) is starting to change its tune?

http://www.forbes.com/2007/06/14/dendreon-gold-closer-market…

[GuHu1]

@ ditzbert, wäre nett wenn du ein kurzes summary über deinen trip to USA erstellen könntest. es gibt ausser mir sicher den einen oder anderen den es interessiert.

muss keine doktorarbeit werden, kurz und knapp.

[gloeckner74]

Antwort auf Beitrag Nr.: 29.937.532 von surga am 15.06.07 12:19:43

war schon immer so.

[GuHu1]

Hmmmm, Hakur, was meinst du

NEW YORK, Jun 19, 2007 (BUSINESS WIRE) -- The Depository Trust and Clearing Corporation (DTCC) today commended--and expressed full support for--the Securities and Exchange Commission's (SEC) decision to give the public greater access to aggregate information on Fails to Deliver (FTDs).
DTCC's comments follow the SEC's recent decision to change short selling regulations, including eliminating the "grandfather" clause and the "uptick" requirement for short selling. In conjunction with these rule changes, the SEC announced it would consider releasing two-month-old, aggregated FTD data on a quarterly basis.
Currently, the SEC does not provide fails information to the public on a regular basis and releases fails data only under Freedom of Information Act (FOIA) requests, provided the released data is at least two months old. This policy was intended to safeguard confidential investor trading information that, if disclosed, could be used by others to gain competitive advantage or manipulate the market. Under the SEC's new plan, aggregated data on fails would be released to the public, without the need for a FOIA request.
DTCC had recommended in a comment letter to the SEC last September on Reg SHO reform, that such data could be released publicly without putting at risk the confidentiality of participant securities holdings and trading or risking market manipulation.
DTCC and its subsidiaries play a critical role in the clearance and settlement of virtually all equity and fixed income trades in the U.S. While their systems will identify many failed trades, DTCC's clearing subsidiary does not have access to the underlying reasons for the fail, which is only known to the firm involved.
The SEC has pointed out that most fails are usually temporary in nature due to administrative error by the end investor or the broker/dealer, though fails can also be caused by abusive trading activity. For that reason, the SEC and marketplaces monitor and investigate fails data to help uncover such activity.
"Our position is that disclosing aggregated historical data in each security on a regular basis, especially now that the grandfathering of fails is ending, would demonstrate convincingly the relatively low level of failed trades that actually exist, and that such information would end much of the speculation about the level of fails in our system," said Larry E. Thompson, DTCC's general counsel.
Since the inception of DTCC's subsidiaries in the late 1970s, great attention has been paid to ensuring the confidentiality of information these subsidiaries possess about a financial firms' specific securities holdings and securities trading activity. To preserve this confidentiality, the ability to release information is sharply restricted by DTCC's subsidiary rules, and the financial firms, institutional investors and others who participate in the capital markets.
"Notwithstanding this history," said Thompson, "DTCC believes it is both possible and beneficial to address the public's interest in FTDs while continuing to protect the legitimate privacy concerns of our participants--and investors.
"DTCC also believes that greater transparency will build confidence in our system for clearing and settling securities trades and thus create a greater appreciation for the benefits of the system's efficiency and effectiveness," said Thompson.
About DTCC
The Depository Trust & Clearing Corporation (DTCC), through its subsidiaries, provides clearance, settlement and information services for equities, corporate and municipal bonds, government and mortgage-backed securities, money market instruments and over-the-counter derivatives. In addition, DTCC is a leading processor of mutual funds and insurance transactions, linking funds and carriers with their distribution networks. DTCC's depository provides custody and asset servicing for 2.8 million securities issues from the United States and 100 other countries and territories, valued at $36 trillion. Last year, DTCC settled more than $1.5 quadrillion in securities transactions. DTCC has operating facilities in multiple locations in the United States and overseas. For more information on DTCC, visit www.dtcc.com.
SOURCE: The Depository Trust and Clearing Corporation
DTCC Stuart Z. Goldstein, 212-855-5470 [e-mail] Copyright Business Wire 2007

[hakur]

Antwort auf Beitrag Nr.: 30.029.265 von GuHu1 am 19.06.07 22:18:39

hi guhu
habe von verschiedenen Seiten Infos , dass die Shorts wohl von ganz oben unter Druck gesetzt werden.
Auszug eines Mails:

Subject: news
Maybe the FTD shorts still do have to be closed out.

If this happens, it can only be attributable to the Federal Reserve Bank. They can make anything happen. It's just that the SEC are a bunch of Hollywood wanna-be movie stars. They don't want to get their fingernails dirty.


weiter:
Hedge funds have far more to fear than SEC
SEC is ineffective an out of the picture now

Entirely new situation has developed-

Looks like they're serious this time-

No details but it's real

It has just begun


hier etwas ganz anderes, hat jemand eine tolle Webseite besser einen Blog über Dendreon gebaut;

http://provenge.blogspot.com/

so loong

[hakur]

habs fast vergessen,
der Chart hält immer noch das Wasser!
still hope

[hakur]

Antwort auf Beitrag Nr.: 30.030.928 von hakur am 20.06.07 00:01:04

stelle den Link des Blogs nochmal extra rein,
finde ihn einfach toll.



http://provenge.blogspot.com/

[GuHu1]

Antwort auf Beitrag Nr.: 30.031.239 von hakur am 20.06.07 00:22:31

Hi Hakur, ich kenne den, ist nicht schlecht gelle.

kleiner tipp beim einstellen von links, klick bei werkzeuge in das feld URL einfügen.
zwischen die kürzel setzt du dann den link.

[BrauchGeld]

Short interest steigt von monat zu monat und die Institutionellen sind am flüchten ,wenn das mal keine guten aussichten sind ..........


Short Interest:

http://www.nasdaq.com/asp/quotes_full.asp?mode=&kind=shortin…

Institutional Holdings:

http://www-qc.nasdaq.com/asp/holdings.asp?mode=&kind=&symbol…

[LaPlue]

Antwort auf Beitrag Nr.: 30.082.695 von BrauchGeld am 20.06.07 21:46:53

"Short interest steigt von monat zu monat und die Institutionellen sind am flüchten ,wenn das mal keine guten aussichten sind .........."



wie kommst du da auf gute aussichten für dendreon ?

[gloeckner74]

Antwort auf Beitrag Nr.: 30.083.205 von LaPlue am 20.06.07 22:08:03

das würde mich auch mal interessieren.

[BrauchGeld]

Noch nie was von "ironie" gehört ?

[hakur]

Antwort auf Beitrag Nr.: 30.082.695 von BrauchGeld am 20.06.07 21:46:53

um die liste zu vervollständigen

http://www.schaeffersresearch.com/streetools/filters/equity_…
nur noch dndn eingeben
siehe da , ziemlich blau

[bernie55]

ALLGEMEINE INFOS zur Zulassung neuer Arzneien


22.06.2007 - 09:28 Uhr

FTD: Das kann ja heiter werden

Die Zulassung neuer Arzneien ist für die Pharmabranche längst keine Kleinigkeit mehr. Regelmäßig lassen die Behörden Hoffnungsträger durchfallen und Börsenträume platzen. Künftig kommt es noch dicker.


Sanofi-Aventis ist fassungslos über die Ablehnung seiner Diätpille Acomplia bei der US-Behörde FDA. Begründung: psychische Nebenwirkungen.

GlaxoSmithKline fürchtet das Aus für das umsatzstarke Diabetesmittel Avandia. Risiko: Herzinfarkt.

Das neue Krebsmittel Vectibix vom weltgrößten Biotechkonzern Amgen findet nicht den Zuspruch der Kontrolleure bei der EU-Behörde Emea. Erklärung: Wirksamkeit zweifelhaft.

Drei Beispiele aus der jüngsten Vergangenheit - eine gemeinsame Wirkung: Aufruhr an der Börse. Die Aktienkurse der betreffenden Konzerne sackten nacheinander auf ein Zweijahrestief. Allen Beteiligten, den Managern, Analysten und Kontrolleuren steckt noch der Skandal um das Schmerzmittel Vioxx in den Knochen. Die Folge für den Hersteller Merck & Co. sowie die Branche waren Tausende Schadensersatzklagen, Imagekrisen und Milliardenverluste. Das mahnte zur Vorsicht. Im Jahr drei nach Vioxx zieht die Politik auf beiden Seiten des Atlantiks die Zügel nun noch fester an.

So feilten am Donnerstag in Washington US-Senatoren an letzten Details für ein Gesetz, das der FDA mehr Einfluss und Geld für zusätzliche Sicherheitskontrollen von Medikamenten gibt. Dazu zahlt die Industrie an die FDA Gebühren von rund 400 Mio. $ jährlich, weitere 225 Mio. $ bringt sie in den kommenden fünf Jahren für die FDA-Observierung von Neueinführungen auf. "Die Nation hat aus den Sicherheitsproblemen mit dem Diabetesmedikament Avandia gelernt", sagte der Vorsitzende des Kongressausschusses, John Dingell, vor wenigen Tagen. Zudem können Verstöße gegen Marketing- und Sicherheitsauflagen mit bis zu 100 Mio. $
Strafe geahndet werden.

Und auch die Emea kann nun härter durchgreifen. Die EU-Kommission hat am 15. Juni eine Verordnung in Kraft gesetzt die Verstöße gegen Emea-Regeln mit hohen Geldbußen ahndet - etwa, wenn Firmen Vorgaben ihrer Arzneimittelzulassungen nicht einhalten, Informationen zur Risikobewertung ihrer Produkte zurückhalten oder deren Nebenwirkungen gar nicht oder erst sehr spät melden.

"Sehr harte Sanktionen"

Die Höchstgrenze der Geldbußen liegt bei fünf Prozent des Jahresumsatzes des betroffenen Zulassungsinhabers. Zulassungsinhaber kann auch eine Konzerntochter sein. "Das dürfte zu ungerechten Bestrafungen führen", sagte Unternehmensanwalt Uwe Fröhlich vom Pharmakonzern Baxter. "Zufälligerweise oder sogar absichtlich kann ein besonders umsatzstarker oder umsatzschwacher Teil eines Konzerns Inhaber der Zulassung sein. Ein Schlupfloch könnten auch Vermarktungspartnerschaften unabhängiger Unternehmen bieten, von denen nur eines die Zulassung hält." Gerechter sei es, die Buße am EU-weiten Umsatz der Arznei festzumachen. "Das sind alles in allem sehr harte Sanktionen", sagt Anwalt Jörg Schickert von der Kanzlei Lovells in München. Er findet manches an der Verordnung unausgereift. "Es gibt noch Schwachstellen, darunter die Frage, wie die Abgrenzung zwischen einzelstaatlichen Strafmaßnahmen und EU-weiten Sanktionen geregelt werden soll."

Das für Zulassungen zuständige Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) habe in der jüngeren Vergangenheit einige Straf- und Bußgeldverfahren eingeleitet, mit unterschiedlichem Ausgang entsprechend der Beweislage, heißt es auf Anfrage. "Ob es in Zukunft wichtiger sein wird, derartige Instrumentarien zur Verfügung zu haben, lässt sich nur schwer einschätzen", so das BfArM. Die im Arzneimittelgesetz für Ordnungswidrigkeiten vorgesehenen Bußgelder von maximal 25.000 Euro seien vergleichsweise gering.

Die Verordnung (EG) 658/2007 zur Auferlegung von Geldbußen durch die Kommission ist ein neuartiges Sanktionsmittel, das es für von der Emea zugelassene Arzneimittel bislang noch nicht gab. "Die Industrie sollte schnellstmöglich alle Schwachstellen abklopfen und Verfahren aufsetzen, die zukünftig Verstöße vermeiden. Dies sollte auch dokumentiert werden", sagte der Anwalt Schickert.

Emea-Chef Thomas Lönngren zumindest will nie mehr einen Tag wie den 30. September 2004 erleben: Weder der Vioxx-Hersteller Merck & Co. noch die FDA-Kollegen hatten ihn frühzeitig über den geplanten Rückruf der Schmerzpille informiert. Die Börse wusste früher Bescheid als er. "Wir wollen von Konzernen so schnell wie möglich informiert werden", sagte er.



Autor/Autoren: Peter Kuchenbuch

http://www.finanztreff.de/ftreff/news.htm?sektion=topthemen&…

[LaPlue]

Antwort auf Beitrag Nr.: 30.145.186 von bernie55 am 22.06.07 11:39:22

also wenn das mal keine gute nachricht ist!

1. Wackelkandidaten, die erhebliche Nebenwirkungen zeigen, werden nicht zugelassen.... verständlich

2. diese Nachricht spricht DNDN in keinsterweise an

3. DNDN hat die Zulassung für Provenge nicht bekommen, da der DNDN- Vorstand leichfertige Test-Abweichungen hat durchgehen lassen.

4. Provenge erfolgreich getestet wurde und ,davon bin ich überzeugt, die nächsten Monate zur Zulassung getestet wird

5. da Provenge eine nachgewiesene lebenserhaltende Wirkung hat

6. Kleinanleger und Ungeduldige sich diese Woche durch den Kursrückgang und nach diesen Panikmacher-News verabschieden. (NasDAQ im Minus, Dax im MInus)

7. DNDN immer noch ein "hochspekulatives" Investment für "Börsenspezialisten" ist

8. ich von einem satten Urlaubsgeld Ende August durch DNDN- Aktien überzeugt bin.


die Moral von der geschichte: cool bleiben und investieren. jetzt erst recht.

ich auf jeden fall habe nachgekauft.

[GuHu1]

Antwort auf Beitrag Nr.: 30.155.951 von LaPlue am 22.06.07 21:11:45

die Moral von der geschichte: cool bleiben und investieren. jetzt erst recht.

ich auf jeden fall habe nachgekauft.

ich finde deine entscheidung ganz schön mutig.
nachkaufen werde ich jetzt noch nicht.
aber wann findet man schon den 100% richtigen zeitpunkt

[BrauchGeld]

Antwort auf Beitrag Nr.: 30.155.951 von LaPlue am 22.06.07 21:11:45

"8. ich von einem satten Urlaubsgeld Ende August durch DNDN- Aktien überzeugt bin. "

Naja auf dem balkon kann es auch gemütlich sein

[GuHu1]

Antwort auf Beitrag Nr.: 30.156.381 von BrauchGeld am 22.06.07 21:43:34

ich wünsch dir von herzen urlaub weit weit weg.

dazu dann das, IV board:
das ist nicht der horror den man erwartet.

Here's Another Horror Story on 9902b Enrollment Ills! /


As I have posted recently, I am trying to get a friend into 9902b. It is an education in itself.

Whereas Demotek found a hint of the diabolical in his Clevelnad experience, I found just another one of those inexplicable human errors I was speaking about this morning (in a different post on another subject).

Human error is the bane of our existence. We are so incredibly fallible that we can accept even a wrongly-phrased utterly and absolutely crucial question in the Provenge Advisory Council briefing documents as "a simple mistake." And I say to you,. "Suurrrrre it was!"

Today, my friend called an out-of-state clinic in the Oncology Department in a famed University to set up an appointment (as we were instructed to do by the Dendreon Trial manager in Seattle.

We had agreed that he needed to run down a check list of criteria to see if he was eligible or if he was not. (This list of criteria is lengthy and technical--a tough proposition for one unschooled to the science (both existing and coming--meaning both chemo and immuno).

Well the helpful lady assigned to handle people like my friend already had a check list and this was her goal as well.

So they worked their way through seven or so questions and she asked for his Gleason Score. He replied that it was an eight. She then told him that she was very sorry that he would not qualify for the study since they were taking only those who were Gleason 7 or below (those less sick than my friend). At this point she ended the call and sent him away to die.

He called me and told me how it had turned out.

I told him that the Trial Design was changed some time ago to include all Gleason scores and that I believed her to be in error. He gave me permission to call her and I did.

I introduced myself and told her that I was almost certain that the Trial requirement on Gleason Scores had been changed some time ago--at least six or more months ago--and she asked me to hold while she checked further in her files. She came back on the line and said.that I was absolutely right, that it indeed had been changed. She then explained that she had checked while talking to my friend in a place where the update had not been made and that this information is also stored somewhere else where she found that it was as I had said it would be.

Despite that this was an Oncology Office, I believe that the failure to update both records was simply human error--not a deliberate attempt to deny people access. Yet they sent a patient away to die!

Good Lord!

You wonder why 9902b is so slow to enroll? Who in Dendreon is monitoring this mess? Can it even be monitored?

I asked her to call my friend back and continue with the check list--adding that I wanted him admitted to this Trial and it was up to her to get him into it![/i]

[GuHu1]

Antwort auf Beitrag Nr.: 30.156.381 von BrauchGeld am 22.06.07 21:43:34

@ BrauchGeld ich wünsch dir natürlich auch deinen wohlverdienten urlaub aber eigentlich wollte ich LaPlue antworten.

sorry ihr beiden für die verwechsellung.

[GuHu1]

von unserem ?ehemaligen? CEO fordwill, IV board:

The Russell
The Russell index is merely an index used for showing a simulated portfolio of the smaller capitalize companies in the US. What many don't understand that this is a surogate that many funds try to use as a yardstick for performance.

Aggressive growth stock funds will pick an index or a basketful of indices to generate their manager's annual performances. It makes sense that once a year that the Russell 2000, Russell 3000 and Russell 5000 ask the question, does our index properly reflect all areas of growth or stagnation in the US economy for our targeted companies? Without this periodic questioning, their index falls away from predicting the true growth of the economy and thus becomes irrelevant if not maintained.

How do they choose their stocks? Actually, extremely carefully. They have hundreds of millions of data points to draw upon. Their econometricians (PhDs in Economics/Mathmatics) build huge portfolio models that will generate Gross National Income points for smaller captilized companies). Their value is only in their predictive ability. People like Dun and Bradstreet then buy the model for their own profit planning. Big banks ( and this is how I know about this...) buy the product so the Commercial Bankers can know where the heck the market is going for their lending purposes. I'd sit there and question the annual plan to be sure our internal economic assumptions were somewhat logical if they departed from such publically available tools.

In our particular case as shareholders of Dendreon, biotechs did not grow all that much, especially in light with manufacturing in 2006/7 or basic materials like cement, steel, and precious metals. So, the Russell folks placed more growth emphasis into those sectors away from biotech. Thus, the rebalancing this year went away from biotech into manufacturing and basic materials like copper, silver and coal and even gas.

Here's the real kick in the teeth, folks. Remember I said that the Russell is only an index... Well, the funds that are tied to the indices have to physically buy/sell stock to rebalance their portfolios too. The index gives out their percentages to all of the differenct sector funds, index funds and what not. The actual damage that we saw today was possible just some of the rebalancing afoot. There might be more coming our way. Lastly, there are hedge funds AND ETFs that are tied to the Russell's in part. Example... 15% of a portfolio's value is represented by smaller capitalized companies based upon the Russell 5,000. So, these guys rebalance in turn.

In short, this is a strange dance that lasts a few weeks in June behind the scenes with the market makers.

Not to worry about such machinations. These are not real demand indicators for the stock. These are just "technical" buys/sells" that don't reflect the current market's appetitite for DNDN shares.

In years past, the market quickly returns to normal and the Russell impacts are washed into history quickly.

Fordwill1953

[LaPlue]

Antwort auf Beitrag Nr.: 30.157.547 von GuHu1 am 22.06.07 23:41:40

Der spricht mir aus der Seele

[GuHu1]

Antwort auf Beitrag Nr.: 30.157.615 von LaPlue am 22.06.07 23:53:23

mir auch

die gerüchteküche wird mal wieder bemüht

http://www.marketwatch.com/news/story/more-biotech-partnersh…" target="_blank" rel="nofollow ugc noopener">http://www.marketwatch.com/news/story/more-biotech-partnersh…

[hri]

More biotech partnerships expectedNeedham & Co. analysts Dendreon, Dyax, Isis among those likely to seek partners for drugs

By Carolyn Pritchard, MarketWatch
Last Update: 3:40 PM ET Jun 25, 2007


SAN FRANCISCO (MarketWatch) -- The number of partnerships in the biotechnology sector is continuing to grow and shows no sign of abating any time soon, according to analysts at Needham & Co.
"We expect this trend to continue, as big pharma and established biotechs seek to add new technology platforms and supplement their clinical pipelines," analysts Mark Monane and Alan Carr wrote in their annual partnership opportunities report, released Monday. Biotech-to-biotech partnerships are becoming more common, they noted, a development they attribute to the maturation of the industry overall.
Monane and Carr identified numerous drug candidates within the universe of their small-cap biotech coverage for which they believe the developing companies will seek partners, including Dendreon Corp.'s (DNDN : dendreon corp com
News , chart , profile , more
Last: 6.73-0.05-0.74%

4:03am 06/26/2007

Delayed quote dataAdd to portfolio
Analyst
Create alertInsider
Discuss
Financials
Sponsored by:
DNDN6.73, -0.05, -0.7%) experimental prostate cancer treatment, Provenge. "We believe that Dendreon will seek an ex-U.S. partner for [the] development and commercialization of Provenge," they wrote.

[Bachalor]

nach und nach bröckelt der kurs ab

[Bachalor]

na das sieht ja wieder freundlicher aus

das tal scheint durchschritten

[Bachalor]

bid und ask recht voll

patt zur zeit

http://datasvr.tradearca.com/arcadataserver/JArcaBook.php?Sy…

[hakur]

Antwort auf Beitrag Nr.: 30.353.343 von Bachalor am 27.06.07 18:25:54

wenn wir grün enden, vielleicht auch noch Tageshoch wäre dies möglicherweise, ein erstmal vorsichtig ausgedrückt,
- kleiner turnaround-

[Bachalor]

Antwort auf Beitrag Nr.: 30.353.787 von hakur am 27.06.07 18:50:09

mich faziniert immer wieder
wenn man den link nimmt
und die sache etwas beobachtet
wie manche blitzschnell manchmal ein brikett(paket aktien)hinterherschieb
ob ins bid oder ask

genauso
wie schnell manche pakete zurückgezogen werden
kurz bevor sie angerknabbert würden

[eck64]

[NoSelters]

Antwort auf Beitrag Nr.: 30.353.787 von hakur am 27.06.07 18:50:09

Boden...???

[hakur]

Antwort auf Beitrag Nr.: 30.354.616 von NoSelters am 27.06.07 19:38:31

habs schon geschrieben ,
wenn wir heute auf Tageshoch schließen siehts sehr gut aus.
Bleibe mal lieber etwas moll, allses andere sehen wir.

das Bildchen hast Du von einem sehr guten Bekannten von mir ;-)
Wir sind in permanenten Austausch was TA betrifft.
Er intersante Vermutungen was die Naked shorts betrifft. Wenns zutrifft sollten wir gute Zeiten sehen.
so long

[NoSelters]

Antwort auf Beitrag Nr.: 30.355.843 von hakur am 27.06.07 20:27:26

Thanks...!!

Oh Mann,meine Nerven....

NoSelters

[hakur]

Antwort auf Beitrag Nr.: 30.355.843 von hakur am 27.06.07 20:27:26

sieht so aus als ob wir das moll Stück einpacken könnten!
Tageshoch wäre immer noch super bullisch zu bewerten!
Grün ist besser als nichts

[GuHu1]

Antwort auf Beitrag Nr.: 30.356.134 von hakur am 27.06.07 20:38:58

recht gute antwort auf die fragen der letzten tage.
ohne news kräftig angezogen.
Fordwill:

Simple math
Let\'s simulate this little nightmare for the shorts. Let\'s say 800.000 shares just purchased entirely covered a short. So, as a percent of all shorts, let\'s just hypothesize this represents about 5% or 800,000 / 41,000,000 of the uncovered mess.

The stock jumped more than $0.50 cents. That should give you all you need to know about the supply for DNDN shares. It is still mostly inelastic, that is, it doesn\'t exist unless another short is offering the shares. A simpler way to think about the supply... there is no supply at these prices. Triple the price and you might free up 10 million shares. But, that still leaves a huge shorted number floating about.

Don\'t let the market kid you. Dendreon is a very scarce good. The shorts are truly trapped. All they can do is go deeper into a hole and rot the market price some more... but, in so doing, they\'ve destroyed any possibilities of escape further into the future.

How do you kill the shorts? By carefully adding shares and holding on until this is approved. Be like me. No need to post often. Every reason to hang onto my shares and add with the little dips ahead.

Screw the shorts.

[GuHu1]

Dendreon: What's Up With The Stock Today?

http://www.cnbc.com/id/19464661" target="_blank" rel="nofollow ugc noopener">http://www.cnbc.com/id/19464661

[hakur]

Antwort auf Beitrag Nr.: 30.357.676 von GuHu1 am 27.06.07 21:43:04

es gibt eine Vermutung , dass die FED ( nicht die FDA) die Daumenschrauben anzieht.
Die Naked Shorts haben die offene Tür die sie seit dem 9.Mai geboten bekamen nicht genutzt. Langsam schließt sich diese wieder, ich möchte da meine Hand nicht drinnen haben an deren Stelle.
Ist ne Info von Backstage im IV.
News würden das Ding regelrecht explodieren lassen.
Wie man sieht sind die im Moment kaum notwendig. Die Shorts gaben sich größte Mühe das Teil in ~20 Tagen bnach unten zu schrauben und in 2 Stunden war dieser Aufwand weggblasen.
So long

sieht gut aus

[GuHu1]

Antwort auf Beitrag Nr.: 30.359.155 von hakur am 27.06.07 22:52:16

wird auch langsam zeit denen auf die finger zu hauen.

News würden das Ding regelrecht explodieren lassen.

na dann, wir sind bereit

[Bachalor]

ich glaube ich gehe öfters mal weg

mal sehen wie es weitergeht morgen

[GuHu1]

könnte passen hakur:

http://www.247wallst.com/2007/06/short-selling-v.html

[hakur]

Antwort auf Beitrag Nr.: 30.359.805 von GuHu1 am 28.06.07 00:00:47

setz das doch mal ins IV
die Spezialisten dort sollen sich dazu mal äußern.
Der Schlüsselbeitrag hierzu könnte heute message 138279 von tradin_n_mowin gewesen sein.

[Bachalor]

heute laufen wir vornwech

[Bachalor]

keiner da

[GuHu1]

Antwort auf Beitrag Nr.: 30.371.874 von Bachalor am 28.06.07 17:35:19

komm vor du bachalor , ich bin immer da.
mal etwas redseliger mal weniger

[Bachalor]

Antwort auf Beitrag Nr.: 30.376.327 von GuHu1 am 28.06.07 20:49:35

heute nur das grün der letzten 2 tage bestätigen
und ich bin sehr zufrieden
auch wenn es 0.1% wären

[Bachalor]

mal sehen was heute wird

[NoSelters]

Fordwill1953 :

Some thoughts...
I'm heading out for a vacation next week. Staying close but plan on no computer.

Here's my latest wild hair...

Could it be that Doc Gold has played down the real significance of the 9902B trial so that the stock won't take off too soon?

Before anyone accuses me of pumping, schitzophrenia or something worse here's some wild conjecture.... You all might need to get the science experts in here to help us understand this by the end of next week....

1. Is the 9902B a traditional stand alone trial or not?

I argue the latter. It is no longer a traditional trial. It has one purpose only. It is to show that Provenge is efficacious like 9901. It is to merely show support. As a logical extension to this thinking... throw out the Alpha spending. Who cares if the P= .025 or .05? All we care about "does the data support 9901 or not?" That is, does Provenge provide significant life extending capability by stimulating a patience's immune system to fight prostate cancer?

Here's what I'm thinking... If the rate of death in the untreated arms is sufficiently higher than the treated arms, and Dendreon can claim anything close to the 3x survival advantage at the end of 36 months by using Provenge, then it is a slam dunk.

But Ford, we're are talking about the "interim look"....

2. Go to the DNDN website and check out the 9901 slide that had the Kaplan/Meier curves on it. It starts showing separation between the treated arm and the placebo about the 14th month.

If Gold can get similiar tracking with 9902B, could he not also be able to then argue that 9902B is new, additional data showing efficacy? And if so, could he then argue for an approvable letter with rights to immediately launch to market Provenge on the condition that DNDN continue to track the death rate between the 2 groups?

3. Where's the critical 14th month with respect to the 9902B patients? Well, that's a messy question because the data is really spread out due to the slow enrollment for the trial. My personal guess that they already have quite a few deaths in hand but may not know if they are from the placebo arm or treated arm.

4. Could not then we have a pattern here that far speeds up the process? We toss the Alpha comparison and only look to survival as a simple question... is 9902B supportive of 9901?

5. Mitch made a rather mysterious/cryptic comment about the number of rated deaths that needed to occur for them to respond to the CR Letter. Certainly someone has that worked out. 320 deaths? 280 deaths? or? But, would he not argue to upgrade the CR Letter to an Approvable Letter with rights to market if the survival stats show an indication of support? My investment bet says he will.

Here's somethings we need to really understand to force this hypothesis onto firm land....

1. Is a supportive trial all that's needed? No formal log test. Only a score of survival months?
2. If DNDN writes up such data, does not the FDA have another 6 months to review the latest info in light of their current BLA?
3. Would DNDN choose to rewrite their entire BLA with 9902B data replacing the 9902A data under the 9902B SPA guidelines?

All of these questions beg a detailed answer.

My own personal bias is that we are a lot closer than we think we are because we don't have to go through a ton of hoopla here. With the political pressure in place, the FDA wants this done yesterday and put to bed once and for all. They'd love to blunt the Abrigail lawsuit with a Provenge conditional approval...

So, could we begin to see enough separation with a lionshare of the data as early as November this year with a 6 month review puts an FDA response into May 2008????

Could it be?????

Fordwill1953

[GuHu1]

Antwort auf Beitrag Nr.: 30.405.793 von NoSelters am 30.06.07 09:01:14

Hmmm, wer weiß wer weiß.

[GuHu1]

New York Times

http://tinyurl.com/24e6jt

[hri]

By James Altucher
RealMoney.com Contributor
7/2/2007 7:05 AM EDT
Click here for more stories by James Altucher

This week's Top 10 Rocket Stocks of the Week features various momentum stocks that could have easy triggers in this slow, holiday-shortened trading week.




1. The Top 10 Rocket Stocks for This Week
2. 360 Degrees on iPhone
3. Cramer's Take on George Soros' Stocks
4. iPhone's $200 Million Jackpot
5. The 12 Highest-Yielding Dow Stocks







Zecco.com
Fisher Investments

Fidelity Investments
Diora Financial

Charles Schwab
E*TRADE FINANCIAL



The key to choosing rocket stocks -- ones that are ideal for a stock-picking contest like the TheStreet.com's Beat the Street 2.0 -- is to find those that have not just solid fundamentals but also historical volatility and easy triggers as well.

The rocket stocks on this week's list fit each of these criteria.

First up is Dendreon (DNDN - Cramer's Take - Stockpickr - Rating), a biotech company that recently has seen a huge amount of call buying in its July $7.50 and the July $10 options. On Wednesday more than 120,000 contracts were traded and more than 100,000 of them where call-buys for both in-the-money and out-of-the-money July calls.

You don't buy that amount of calls on a $7.40 stock because you think it's a good investment; the investors that make that kind of bet do so because they believe something is going to happen, and happen soon.

Dendreon is a violent stock that has been known to move as much as 40%-50% in one trading day.

[edelupolino]

Antwort auf Beitrag Nr.: 30.447.528 von hri am 02.07.07 13:20:05

hört sich ja vielversprechend an!

[GuHu1]

yep, und das von cramer, hatte der nicht ein kursziel von
$1 - $ 1,50 nach dem 09.05 rausposaunt?

[edelupolino]

Antwort auf Beitrag Nr.: 30.467.486 von GuHu1 am 03.07.07 12:26:34

jau, Cramer sah dndn gegen NULL rasen!

[hakur]

Antwort auf Beitrag Nr.: 30.467.486 von GuHu1 am 03.07.07 12:26:34

nicht nur von Cramer
da gab es doch etliche sich sorgende Propheten die hier an Board aktiv sind

[GuHu1]

liegts möglicherweise daran:
http://www.gerntalk.com/

[GuHu1]

thats from hucki:

http://video.google.com/videoplay?docid=-1801355074812505264…

@ hakur, nah entwickelt sich doch, ist doch ausbaufähig, oder.

[GuHu1]

contra adam f., kann leider keinen link reinstellen, aus dem IV board.

Adam Feuerstein
Dendreon hype
7/3/2007 11:02 AM EDT


I'm spitting mad about Dendreon, and here's why:

CNBC Mike Huckman's "big news" on Dendreon this morning is a newly published paper in the Journal of Clinical Cancer Research which he claims is "taking a second look" at Provenge, concluding that cancer vaccines might be helping patients live longer.

For dramatic effect, Huckman waves a copy of the report in the air like he's found the holy grail.

Well, what the report actually says - if someone takes the time to read it (and I did) -- is that when it comes to cancer vaccines (Provenge and others), using traditional clinical endpoints for cancer trials like tumor shrinkage might not be the best way to assess efficacy. Instead, it might be better to judge cancer vaccines based on their ability to boost survival of patients.

Duh! What's new here? This is precisely the debate about Provenge rehashed. The FDA has already looked at the Provenge survival data and found it lacking. That's why the drug wasn't approved, and why the FDA wants more survival data from an ongoing study.

There is nothing - NOTHING! - in this study hyped by Huckman on Bubblevision that moves the Dendreon story forward one inch. I like Huckman and generally respect his reporting on healthcare but this report is an embarrassment. There is nothing here that promises a "second look" at Provenge.

But Huckman is not the only one at fault, here. What really pisses me off about Dendreon is that the stock is no longer about Provenge or the fundamentals. It's a momentum trading vehicle that will be pumped and dumped based on the flimsiest of rumors and lowest-common denominator reporting.

And sadly, TheStreet.com is getting in the act too. Last week, someone on CNBC's Fast Money TV show says he notices heavy option activity in Dendreon and that he likes the stock. This begets more option buying, which causes my colleague James Altucher to name Dendreon one of his "rocket stocks" of the week.

"You don't buy that amount of calls on a $7.40 stock because you think it's a good investment," Altuchers says, referring to Dendreon. "The investors that make that kind of bet do so because they believe something is going to happen, and happen soon. "

This, then, prompts CNBC to report that TheStreet.com names Dendreon a rocket stock, which begets more options buying, which of course, gets Dendreon common stock jumping. Then, to top it all off, we get Huckman's piece of fluff reporting.

And at the end of the day, there is no news. There is nothing "happening soon." The Dendreon story remains the same as it was before all the hype. What we're left with is a lot of wasted air.

[hakur]

Antwort auf Beitrag Nr.: 30.478.444 von GuHu1 am 03.07.07 23:55:59

@Guhu,-

Danke Dir für den Link,
habe ich glatt übersehen!

anscheinend braut sich da jetzt entsprechend den Ankündigungen im Chart welche schon längere Zeit sichtbar waren etwas in der Wirklichkeit zusammen. Schaut so aus als ob das Durchhalten belohnt wird. Spannung pur.


schöne Sommerzeit!
so loong

-lets wait and see-

[hri]

ich weiss wirklich auch noch nicht was ich davon halten soll, aber wer kauft mehr als 100.000 calls (1 call = 100 aktien) also mehr als 10 mio. aktien in den letzten 2 tagen für 15-30 cnt, die ihn berechtigen die aktien für 10$ zu kaufen? und das beim verfallstag 20.7.07 !

und die mengen bei den calls für august sind selbst bei höheren preisen auch nicht zu verachten.
das scheint mir ein absicherungsgeschäft eines grossen investors zu sein, der insiderwissen haben muss, anders kann ich mir das nicht vorstellen.

gibt es hier os-spezies, die sich einen reim darauf machen können ?

[GuHu1]

Antwort auf Beitrag Nr.: 30.489.834 von hri am 04.07.07 20:16:01

bei den os kann ich nicht weiterhelfen, habe aber noch einen kleinen artikel zum reinstellen.

The Seattle Times Company
Jobs | Autos | Homes | Rentals | NWsource | Classifieds | seattletimes.com

Wednesday, July 4, 2007 - Page updated at 02:02 AM

E-mail article Print view Share: Digg Newsvine

Cancer-vaccine report boosts Dendreon stock
By Ángel González

Seattle Times business reporter

Dendreon shares rose sharply Tuesday as a scientific article cast a positive light on therapeutic cancer vaccines, a family of newly bioengineered products that includes the company's flagship prostate-cancer treatment, Provenge.

The Seattle biotech company's stock closed at $7.70, up 6.5 percent from Monday, after spiking nearly 14 percent in earlier trading.

During the last year, the stock has traded as high as $25.25 and as low as $3.57.

The stock got its boost Tuesday from a study published in the latest issue of Clinical Cancer Research, which said there's mounting evidence that therapeutic cancer vaccines can extend survival and help patients when combined with other therapies.

The peer-reviewed journal is published by the prestigious American Association for Cancer Research.

The U.S. Food and Drug Administration hasn't approved a therapeutic cancer vaccine yet. But the study looked at clinical data from five drugs under review, including Provenge, whose expected launch in May was delayed when the FDA requested more information.

The article's lead author, Jeffrey Schlom, a researcher at the National Cancer Institute in Maryland, said the scientific community should be "thinking slightly differently" about these therapies, which spur the immune system to fight cancer, and not compare them to traditional interventions such as chemotherapy.

"The way most drugs are looked at is 'Do they cause tumor shrinkage?' " Schlom said Tuesday. "The vaccine seems to be keeping the tumor in check or influencing subsequent therapies. We have to be thinking slightly differently."

The article strengthened Dendreon's share prices, but it isn't likely to help Provenge's case with federal regulators, said Paul Latta, an analyst with McAdams Wright Ragen in Seattle.

"As far as Dendreon is concerned, nothing really changes," Latta said. "But it does acknowledge that there ought to be a better way to make the drug available to terminal-cancer patients."

The latest jolt is the stock's second significant move in less than a week. There was a surge in trading after an analyst said last week Dendreon was ripe for a lucrative partnership with a major pharmaceutical company to launch Provenge outside of the U.S.

Nearly 25 million shares traded hands Tuesday. For the last 50 days, the average daily volume has been 22.5 million.


These ups and downs underscore the volatility of popular biotech stocks, as investors read tea leaves while companies deal with regulators to get their products to market.

Dendreon's stock has been on a roller coaster since the FDA in May withheld its blessing on Provenge, the company's first expected product. Many analysts, investors and patients were confident the drug would be approved after a positive review by an FDA advisory panel.

The agency's decision has sparked a debate on how to evaluate innovative biotechnology therapies for terminal-cancer patients.

The adoption of a new way of looking at these products "might happen in time for some of the other cancer immunotherapies that are in the pipeline," Latta said.

[edelupolino]

Antwort auf Beitrag Nr.: 30.489.834 von hri am 04.07.07 20:16:01

das ist schon sehr merkwürdig.

Wenn der aktionär die calls gekauft hat, und die aktie nicht in seinem sinn steigt, werden ihm die dinger ca 1-3 wochen nach dem termin als "wertlos" ausgebucht (Totalverslust),

Kann sein, dass ihm die paar dollar egal sind, weil er eine RIESENCHANCE wittert.

Ohne infos mache ich ihm dies wahnsinnsgeschäft (20.!!!!!7.07) nicht nach!
Ede

[edelupolino]

Antwort auf Beitrag Nr.: 30.490.925 von GuHu1 am 04.07.07 21:13:39

der artikel ist natürlich wasser auf die longie-mühlen.

aber der zeithorizont ist schlecht einzuschätzen.
Ich glaub nicht, dass der OS-man sich daran orientiert hat.

[GuHu1]

Antwort auf Beitrag Nr.: 30.491.954 von edelupolino am 04.07.07 22:03:42

Ich glaub nicht, dass der OS-man sich daran orientiert hat.

das glaub ich auch nicht, das wusste der schon vorher.

ich habe beim überfliegen des IV boards eine interview passage im kopf, kann diese aber nicht zurückverfolgen bzw. eine quelle angeben. wollte, hab aber nicht, diese schon vorher reinstellen.

sinngemäß sagte gold, der abschluss des 9902b enrollment ist nicht das ziel von dndn .....???!!!
das viel mir sofort ins auge, kann viel heißen, gibt mit dem jetzigem kenntnisstand aber ein anderes bild.

ich weiß, dass ist nicht seriös, deshalb bitte nur als neblige erinnerung verbuchen, weil möglicherweise aus dem zusammenhang gerissen.

grundsätzlich habe ich mittlerweile den verdacht, da läuft hinter den kulissen mehr als alle vermuten. meryll, $1 cramer plötzlich auch, die sind doch nicht blöde!

[Juppes13]

Antwort auf Beitrag Nr.: 30.489.834 von hri am 04.07.07 20:16:01

Quelle ??

[hri]

Antwort auf Beitrag Nr.: 30.498.294 von Juppes13 am 05.07.07 06:47:46

http://finance.yahoo.com/q/op?s=DNDN

und time/sale bei meinem ami-broker!

[hri]

Antwort auf Beitrag Nr.: 30.498.294 von Juppes13 am 05.07.07 06:47:46

DNDN -- Dendreon Corp.
Com ($0.001)
COMPANY NEWS AND PRESS RELEASES FROM OTHER SOURCES:

investorIM: Dendreon Corp Sees Huge Amount of Call Buying

Jul 04, 2007 (M2 PRESSWIRE via COMTEX) -- InvestorIM has been created as a tool for the average investor. The idea is simple, a website where the world can communicate. Do you have a stock related question, then why not ask 50,000 individual members? Are you a shareholder of Dendreon Corp (NASDAQNDN)? Join the many members engaged in this stock right now. Come see for yourself at www.investorim.com for your complimentary subscription.
Dendreon a biotech company that recently has seen a huge amount of call buying in its July $7.50 and the July $10 options. On Wednesday 2007-07-03 more than 120,000 contracts were traded and more than 100,000 of them where call-buys for both in-the-money and out-of-the-money July calls.

You don't buy that amount of calls on a $7.40 stock because you think it's a good investment; the investors that make that kind of bet do so because they believe something is going to happen, and happen soon.

Dendreon is a violent stock that has been known to move as much as 40%-50% in one trading day.

[hri]

erste taxe bei Arca 7,70 / 8,40

http://www.level2quotes.com/

[hri]

Antwort auf Beitrag Nr.: 30.478.503 von GuHu1 am 04.07.07 00:09:50

gib mir bitte mal den link vom IV board, danke

[NoSelters]

Antwort auf Beitrag Nr.: 30.500.536 von hri am 05.07.07 10:32:01

http://www.investorvillage.com/smbd.asp?mb=971&clear=1&pt=m

[NoSelters]

Diese elende Ratte...Sorry

http://www.thestreet.com/_yahoo/newsanalysis/biotech/1036618…

[hri]

Antwort auf Beitrag Nr.: 30.503.294 von NoSelters am 05.07.07 13:28:22

passt aber nicht weil dndn auch cramers take ist !

[Bachalor]

Antwort auf Beitrag Nr.: 30.500.346 von hri am 05.07.07 10:21:08

7.86-7.88

[Bachalor]

[Bachalor]

hinderniss bei8.10

[surga]

Antwort auf Beitrag Nr.: 30.506.082 von Bachalor am 05.07.07 15:53:52

My Letter to Dr. von Eschenbach

By: phaider

Subject: DR. HOWARD SCHER’S CONFLICTS OF INTEREST IN THE FDA’S DECISION REGARDING PROVENGE

http://www.investorvillage.com/smbd.asp?mb=971&mn=140449&pt=…

[GuHu1]

Antwort auf Beitrag Nr.: 30.500.536 von hri am 05.07.07 10:32:01

Hier wird auch über die OS situation philosophiert.
Ist möglicherweise etwas für dich hri.

http://www.investorvillage.com/smbd.asp?mb=971&mn=140464&pt=…

[GuHu1]

Ach was, mal was ganz neues

Dendreon "sell"

Thursday, July 05, 2007 8:00:47 AM ET
Brean Murray, Carret & Co

NEW YORK, July 5 (newratings.com) - Analyst Jonathan Aschoff of Brean Murray reiterates his "sell" rating on Dendreon Corp (DNR.FSE). The target price is set to $1.

In a research note published this morning, the analyst mentions that a recent review article proposes that the impact of cancer vaccines on "tumor response" should not be as much the focus as on "patient response." The article fails to boost the chances of success of Provenge’s IMPACT trial, the analyst says. The company’s share price is likely to be volatile going ahead due to the expected failure of the IMPACT’s interim analysis, Brean Murray adds.

[GuHu1]

12,000,000 shares ,thats a lot of retail investors.

na ja 2/3 sind von mir, wer war noch dabei?

[Bachalor]

wer os scheine kennt

könnte sich mal einen apple ansehen
sollte weiterlaufen bis zur einführung des i-phone in europa

z.b wkn cb5nub

geht hier nicht,aber bei consors zb.

mal kleine nebentätigkeit neben dndn

[Bachalor]

!

Dieser Beitrag wurde moderiert.

[Bachalor]

wäre nett mit einer 8 vorm komma ins we zu gehen




könnt ihr in usa nicht ein wenig pushen

[GuHu1]

zwar kein push aber nett zu lesen.

http://www.washingtonpost.com/wp-dyn/content/article/2007/07…

[Bachalor]

jetzt hämmern die das ask aber mächtig voll

http://datasvr.tradearca.com/arcadataserver/JArcaBook.php?Sy…



haben wohl angst wenn die 7.90 genommen wird
dass es kleinen run geben könnte

[GuHu1]

keine sorge, das wird gut kontrolliert.

7.79 $ kann ich auch mit leben.

[edelupolino]

einige hinweise (uU schon bekannt...)

1.Dendreon Gets Divorced From Any Sane Reality
By Adam Feuerstein
Senior Writer
7/5/2007 6:50 AM EDT Thema: Dndn ist
reines spekulationsobjekt geworden


2.Market Strategy
In Defense of the Dendreon Cult
7/3/2007 12:53 PM EDT
James Altucher explains the obsession behind this volatile biotech.


3.Want more? Check out TheStreet.com TV video. Janet Al-Saad takes at look


@ guhu 4150 : bei diesem Asshoff ist das nicht anders zu erwarten...

Gruß Ede

[Bachalor]

[GuHu1]

Nah nah, wer kanns da wieder mal nicht abwarten?

looks like 12 million will be seen in volume today

da kauft man mal ein paar stücke und alle drehen am rad.

[GuHu1]

@hakur
respekt, das hätte ich nicht erwartet.
was sagt denn der chart dazu?

[hakur]

Antwort auf Beitrag Nr.: 30.623.481 von GuHu1 am 10.07.07 22:39:14

@ guhu
wie soll ichs zum Ausdruck bringen,
sitze seit dem ~ 12.Mai da und bin für mich eigentlich sicher dass da Charttechnisch was was kommt!
Habs glaube ich immer so angedeutet.
Bin aber was das Zeitfenster anbetrifft etwas am Schlauch. Könnte sein dass es noch 2 Wochen dauert oder 1 Monat ,.. die 17-18 $ habe ich für mich auf der Rechnung , später mehr.
Was heute passierte war schon ziemlich früh im Handel sichtbar geworden.
Würde gerne ab und zu was Charttechniches intraday einstellen, hab aber bis heute noch nicht geschnallt wie man ein Bild reinstellen kann.
Sieht auf jeden Fall gut aus , sind im grünen Bereich.
so loong

[GuHu1]

auf auf @ all other, zeigt ihm wie es geht mit dem reinstellen des chart, ich weiß es nämlich auch nicht.

[hakur]

Antwort auf Beitrag Nr.: 30.623.871 von GuHu1 am 10.07.07 23:08:54

was geht da denn jetzt after hour ab, ??

[GuHu1]

liegt es daran?

http://investor.dendreon.com/EdgarDetail.cfm?CIK=1107332&FID…

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 2, 2007
DENDREON CORPORATION
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction
of incorporation) 000-30681
(Commission File Number) 22-3203193
(I.R.S. Employer
Identification Number)

3005 First Avenue
Seattle, Washington
98121
(Address of principal executive offices) (zip code)
[phone]
(Registrant’s telephone number, including area code)
None
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))





--------------------------------------------------------------------------------




Item 8.01. Other Events.
On July 2, 2007, Dendreon’s Board of Directors received a letter dated June 28, 2007 from counsel for Harriet Goldstein IRA, a Dendreon stockholder claiming damage to the Company from alleged wrongful disclosure and insider trading and demanding that the Board investigate and take legal action against certain Dendreon officers and directors. The wrongful disclosure allegations stem from Dendreon’s disclosures surrounding correspondence with the FDA during the first half of 2007 pertaining to the Company’s Biologics License Application filed with the FDA for Provenge. This potential claim is not against the Company. The Company’s Board of Directors will be evaluating a response to the letter.
On July 9, 2007, Dendreon Corporation (the “Company”) received a letter from the New York Regional Office of the Securities and Exchange Commission (the “SEC”) dated July 3, 2007, notifying the Company of an informal inquiry related to the Company’s clinical trials for Provenge ® , the Company’s Biologics License Application for Provenge filed with the U.S. Food and Drug Administration (“FDA”), and the FDA’s review of Provenge and related correspondence to and from the Company, from January 1, 2007 through the present. The SEC’s letter notes that the request should not be construed as any indication by the SEC or its staff that a violation of the federal securities laws has occurred nor should it be considered a reflection upon any person, entity or security.
The Company intends to cooperate fully with the SEC staff and respond to the staff’s request for information. The Company does not intend to comment on any aspect of the inquiry or possible outcomes until the inquiry is completed.

[GuHu1]

Aus dem IV Board:

Yes, I did.

"(the "Company") received a letter from the New York Regional Office of the Securities and Exchange Commission (the "SEC") dated July 3, 2007, notifying the Company of an informal inquiry related to the Company's clinical trials for Provenge®, the Company's Biologics License Application for Provenge filed with the U.S. Food and Drug Administration ("FDA"), and the FDA's review of Provenge and related correspondence to and from the Company, from January 1, 2007 through the present."

Why wouldn't the SEC want this information if they are investigating illegal trading by outsiders as well as insiders?

"The SEC's letter notes that the request should not be construed as any indication by the SEC or its staff that a violation of the federal securities laws has occurred nor should it be considered a reflection upon any person, entity or security."

This does not specify what or who the ultimate investigation is regarding.

Wha is your interpretation?

Was geht denn da ab?
Da kann mir einer sagen was er will, spannend ist es bei dndn alle mal.

[Bachalor]

Antwort auf Beitrag Nr.: 30.623.783 von hakur am 10.07.07 22:59:50

morgen


du musst mit der maus auf den chart gehen
rechte maustaste drücken
gehe auf eigenschaften
dann öffnet sich links oben ein fenster
da musst du was hinter
url-adresse steht kopieren
das geht wie folgt
mit dem pfeil,der wird jetzt kleiner balken
vor das http gehen
rechte maustaste drücken,da wird es blau
ganzen url blau machen
rechte maustaste und auf kopieren drücken
(wichtig,muss alles blau sein der komplette url


dann hier posting öffnen
bild einfügen drücken ..
und genau in der mitte zwischen den mittleren balken der beiden img einfügen
geht wie folgt
maus genau zwischen die balken,rechte maustaste drücken und einfügen drücken
das sind bilder,oder chart drin
genausu geht es mit links aus anderen boards nur bei url

ihr kopiert doch auch andere meinungen hier ins forum
ist genau das gleiche,müsst nur bild einfügen benutzen
das ganze klingt schwierig,2-3 mal gemacht,macht ihr das im schlaf

[Bachalor]

Antwort auf Beitrag Nr.: 30.624.718 von Bachalor am 11.07.07 05:29:53

ich habe wie auch ein guter freund aus berlin
probleme zu verstehen was die aus den englischen boards genauer meinen mit ihren aussagen

[Bachalor]

was taxen die in ffm

auch wenn der euro über 1,37 ist

[hri]

Antwort auf Beitrag Nr.: 30.626.130 von Bachalor am 11.07.07 09:34:52

den AH-SK von 7,63 = 5,554

[hri]

Antwort auf Beitrag Nr.: 30.626.130 von Bachalor am 11.07.07 09:34:52

und natürlich die vorb. taxe von NYSEarcade von 7,42 / 8,07

unter http://www.level2quotes.com/

[euroturk]

bin seit längerer zeit in dendreon investiert und habe kaum in forum geschrieben
mich interessiert warum es gestern nachbörslich nochmal unter die 8 $ gefallen ist
gibt es einen bestimmten grund dafür wenn ja wäre ich sehr dankbar wenn es jemand erläutern könnte


danke im voraus und drück uns allen die daumen für ein dunkel grünen Tag

[Bachalor]

Antwort auf Beitrag Nr.: 30.627.818 von euroturk am 11.07.07 11:09:36

gruß
aus der bankenstadt in die hauptstadt

[Bachalor]

Antwort auf Beitrag Nr.: 30.627.191 von hri am 11.07.07 10:34:29

da machen welchr mit denblöden nachbörslichen trades
den kursgewinn von gestern zunichte


aber das ist ja eh kleingram
entweder richtig,oder wie hnab

[euroturk]

Antwort auf Beitrag Nr.: 30.629.518 von Bachalor am 11.07.07 12:38:00

danke grüße zurück

[kfe1000]

Briefing.com (CEGE) Ticker Alert for In Play


11-Jul-07 07:33 ET

Cell Genesys: Expect interim phase III data 1H08, ahaead of provenge - Cantor
(3.74)

Cantor notes yesterday morning CEGE announced the completed enrollment of its
VITAL-1 Phase III clinical trial with over 600 patients for the study of GVAX
immunotherapy for prostate cancer, the first of two Phase III clinical trials,
the largest ever conducted in prostate cancer. Firm expects interim data to be
reported 1H08 with final data analysis before year-end 2009. If this timeline
is met, they think GVAX interim data will be available approx six months ahead
of Provenge interim data and that final GVAX VITAL-1 data analysis could be
presented about one year in advance of Provenge.

[hakur]

Hi @ den nachbörslichen Kurs können wir mit Sicherheit vernachlässigen!
-Entweder Scheinmanöver oder Blindfliegr Tests-

Seht Euch mal den Beitrag Message 142195 von Tradn_mowin im IV an.
Ich denke er liegt richtig mit der Vermutung einer umgekehrten
Schulter , Kopf , Schulter Formation.
Sollte ins Grüne laufen.
Schönen Tag
so loong

http://www1.investorvillage.com/smbd.asp?mb=971&pt=msg&mn=14…

[NoSelters]

Antwort auf Beitrag Nr.: 30.630.542 von hakur am 11.07.07 13:38:22

[hakur]

Antwort auf Beitrag Nr.: 30.630.615 von NoSelters am 11.07.07 13:43:25

Wow , das ging aber schnell!!

[hakur]

Antwort auf Beitrag Nr.: 30.624.718 von Bachalor am 11.07.07 05:29:53

da musst du was hinter
url-adresse steht kopieren

welche url meinst DU?

[Bachalor]

Antwort auf Beitrag Nr.: 30.636.220 von hakur am 11.07.07 18:16:30

gehe doch mal ganz einfach auf den chart von dndn bei wo
linke maustaste drücken auf dem chart
dann ganz unten auf eigenschaften
dann geht ein neues fenster auf
darin steht url-adresse
dieses kopieren

[Bachalor]

kannst auch den von no selters nehmen,ist völlig egal

[surga]

Antwort auf Beitrag Nr.: 30.636.375 von Bachalor am 11.07.07 18:23:05

Ich habe geschafft!!!!!!! Danke

[GuHu1]

Antwort auf Beitrag Nr.: 30.627.818 von euroturk am 11.07.07 11:09:36

kurz und knapp:

die sec ist dabei untersuchungen bei dndn einzuleitet.
diese meldung kam gestern nach börsenschluss, kursverlauf und reaktionen siehst du ja.
da das ( für mich jedenfalls ) noch nicht ganz klar ist welches ziel dabei verfolgt wird, gibt es entsprechend spekulationen wie z.b.:

- die untersuchungen beziehen sich auf insider handel des
managments ( lawsuit läuft ja auch ). für mich am
naheliegensten, was aber nicht heißt
das dieses nachweisbar ist bzw. stimmt.
- sec beleuchtet die hohe nacked shortrate und das verhalten der
mm vor/am 09.05. na ja
- sec beleuchtet das verhalten von scher, hussain und fda
mitarbeitern ( cancer letter und conflict of interest /COI ).
für mich eher unwarscheinlich.

wie gesagt spekulationen aber ich tendiere zum ersten punkt.
hat noch jemand was zuzufügen oder zu korrigieren?

[Bachalor]

Antwort auf Beitrag Nr.: 30.636.702 von GuHu1 am 11.07.07 18:38:31

sorry wenn ich einiges aus denm zusammenhang reiße
können wir ja alles löschen lassen

sugar
das geht mit allen bildern
wo nzu kopieren sind
genauso mit links zu anderen internetseiten
diese müsst ihr dann anstatt bei bild bei url einfügen eingeben

ihr könnt hier doch aich testen
dann könnt ihr euch gegenseitig helfen eure fehler zu bearbeiten
anschliessend lassen wir alles unütze zeug von mods löschen

[Bachalor]

heute wird der kurs wieder festgenagelt
bis er ausbricht


http://datasvr.tradearca.com/arcadataserver/JArcaBook.php?Sy…




@hakur
bm und e-mail

@all
ich lasse heute nacht einiges von mir löschen
nicht wundern wenn einiges unütze morgen fehlt

[GuHu1]

Antwort auf Beitrag Nr.: 30.637.514 von Bachalor am 11.07.07 19:15:55

was mich dabei verblüfft, nach einer vermeintlich ganz miesen news ist dndn stark wie lange nicht mehr.
was ist da wirklich los?
bisher nur spekulationen oder hat von euch einer was konkretes?

[Bachalor]

Antwort auf Beitrag Nr.: 30.641.183 von GuHu1 am 11.07.07 21:33:13

und es bricht immer nach oben aus wenn ffm geschlossen hat


würde mich nicht wundern
wenn da einige bewusst noch aufsaugen was geht
und hier an einem tag irgendwann mal der punk abgeht mit 40-50%
ohne meldung

[Bachalor]

so noch kleiner ausgang

[NoSelters]

Antwort auf Beitrag Nr.: 30.641.183 von GuHu1 am 11.07.07 21:33:13

Hmmmh...Deshalb vielleicht

http://www.marketwatch.com/news/story/sec-launches-informal-…

[GuHu1]

Antwort auf Beitrag Nr.: 30.642.657 von Bachalor am 11.07.07 22:26:57

wen sollen die beiden denn da durchlassen?

ich wäre da nicht so nett, stell lieber noch nen dritten vor die tür.
mal im ernst, das dndn um 7,95 schließt hätte ich nicht gedacht, zeitweise standen 8 + auf der uhr.

ich fahre am freitag in urlaub und das jetzt , wenn ich storniere bringt mich meine familie möglicherweise um.

bin morgen aber noch mal dabei!

[Bachalor]

Antwort auf Beitrag Nr.: 30.642.890 von GuHu1 am 11.07.07 22:38:42

werden langsam alt


ich suche bei finanznachrichten was von dndn
ich dachte heute mittag eine meldung gelesen zu haben
bin mir nicht sicher

[GuHu1]

Antwort auf Beitrag Nr.: 30.642.829 von NoSelters am 11.07.07 22:35:30

hi no selters,
habe auch mehrere solcher links gefunden ( forbes und und und ).
das ist wiedermal typisch, die wissen alle nicht worum es wirklich geht, aber jeder muss seinen senf dazu geben.

ich will das jetzt nicht alles aufzählen, ich meine, lass uns mal etwas warten.

[hakur]

Antwort auf Beitrag Nr.: 30.642.890 von GuHu1 am 11.07.07 22:38:42

tia ,
da könntest Du wirklich ein Problem bekommen - egal wie Du dich entscheidest. ;-)
Hastn mail


@ bachalor Du auch

[GuHu1]

Antwort auf Beitrag Nr.: 30.643.646 von hakur am 11.07.07 23:20:46

ha ha du witzbold.
werde mittel und wege finden hier mal ab und zu reinzuschaun.

danke hakur, das kann ich nach den letzten 2 tagen nachvollziehen.
ich finde das teil verhält sich untypisch, aber gut, wir werden sehen.

hab ich doch voll vergessen: DHSZ !

[GuHu1]

ich will hier nicht auf die tränendrüse drücken aber die meinung ist es wert reigestellt zu werden ( IV ):

One thing that bothered me after the AC panel vote was the huge short intrest that only increased!
That is the main reason I sold half my position ~$750,000 worth of calls options! by the way I always take some money off the table after a big move in a stock! Now not to say when I watched my call option that I had held on to drop from a ~800% profit on Black Wed. it hurt!!! In the back of my head I kept on saying to myself damn with this positive vote by the FDA AC panel the only way these shorts would have enough balls to short even more shares is if they had an insider in the FDA that assured them that they were ok!! Think about for a moment if the FDA gave full approval these guys would have lost Billions of Dollars???? IMHO this is what happened and I would bet all my current call option on it!!

[hakur]

Chart update

vom IV --tradin_mowin--

We have arrived again at a confluence of forces.

The "pitchfork" was a brutal test of nerves during the month of June. The purge ended at $6.30 on June 27. What a sigh of relief.

We have worked higher, and now we have two converging areas of supply: the pitchfork again, and our H&S reversal pattern.

If we go higher (through $8.35), the stock will likely move quickly

If the stock fails here, at least we are way off the May low of 4.95, and the June 27 low. The stock will have time and room to work another base.

I have also PMed with our esteemed colleague from Germany, hanslebo. He agrees that we DNDN longs have much to be optimistic about, both in the near term, and the long term.

Good luck to all the longs

tradin

http://www1.investorvillage.com/smbd.asp?mb=971&mn=142860&pt…

[NoSelters]

Antwort auf Beitrag Nr.: 30.652.445 von hakur am 12.07.07 13:17:38

[NoSelters]

Antwort auf Beitrag Nr.: 30.652.445 von hakur am 12.07.07 13:17:38

Hakur = Hanslebo ??


Gruß

No

[NoSelters]

Noch ein Artikel...

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/07/12/…

No

[Bachalor]

guten tag





aufi
schnell über die 8

[Fire2]

heute ausbruch vor 20 uhr

vorbereitungen laufen wohl an

[Bachalor]

bid stabilisiert sich gut über 7.80

aber bei 7.86 liegen 13k


http://datasvr.tradearca.com/arcadataserver/JArcaBook.php?Sy…

[Bachalor]

eisblock ist wech


aufi gehts


8 in sicht

[Bachalor]

7.98

und keiner da


da liegt 15 k block



hau wechdie sch......

[Bachalor]

warten doch wieder bis 20.30-21 uhr mit der 8

[euroturk]

Guten abend allerseits hab eine frage
ist eine frist gesetzt wann die fda etwas sagt
und warum hört man von seiten dendreon nichts ???

danke im voraus
Bachalor heute werden wir bestimmten über 8 schließen

[GuHu1]

Antwort auf Beitrag Nr.: 30.660.103 von euroturk am 12.07.07 20:27:20

was erwartest du von der fda?
die haben die forderungen zum approval an dndn durch den crl ( hier stehen die gründe warum keine sofortige zulassung erfolgte ) formuliert.

dendreon hat dazu nur wenig einblicke gewährt, bis auf das die fragen in absehbarer zeit geklärt werden und sie eng mit der fda zusammenarbeiten.( sehr verkürtzt und meine worte )

die fda hat daten nachgefordert, aber mittlerweile bin ich auch nicht mehr sicher was da hinter den kulissen abläuft.

die skeptiker gehen / gingen von abschluss der laufenden studie aus, dauert ca. 3 jahre und cramer (us analyst) sah den kurs um $1.

derzeit weitverbreitete meinungen gehen vom komplettieren(patienten anzahl ) der laufenden studie aus und auswerten der zwischenergenbnisse durch die fda aber mit geänderten studien ziel ( survival ), folgen könnte ein approval ca. mitte 2008.

hinzu kommmt die laufende klage gegen das managment ( insider handel ), die anzahl an studienteilnehmern ist ( sowiet mir bekannt ) noch nicht komplett.
sec hat untersuchungen angekündigt / eingeleitet.

das ist jetzt wirklich total verkürzt und vereinfacht.
bitte, wenn ich müll schreibe, verbessert mich auch von der seitenlinie .

bin übrigens noch immer mit meinen gewinnen investiert!
habe kein stück abgegeben oder nachgekauft!

@euroturk, hoffe ich konnte dir ein wenig weiterhelfen.

[GuHu1]

Aus dem IV Board:

SOMETHING IS GOING TO HAPPEN TONIGHT OR TOMORROW..CHECK OUT THE AFTER HOURS BLOCKS TRADING ON THE NASDAQ
HMMM...PLEASE

ich sage jetzt tschüß, fahre in urlaub.
habe keinen stopp gesetzt, also schön aufpassen, melde mich sicher zwischendurch!

[NoSelters]

...so siehts aus...

[Bachalor]

Antwort auf Beitrag Nr.: 30.662.765 von GuHu1 am 12.07.07 23:01:45

schöner urlaub

[euroturk]

Antwort auf Beitrag Nr.: 30.662.310 von GuHu1 am 12.07.07 22:36:19

vielen dank für deine antwort

und ein erholsamen urlaub wünsch ich dir

[surga]

Antwort auf Beitrag Nr.: 30.665.643 von Bachalor am 13.07.07 09:50:26

Dendreon Under Attack

By Brian Lawler July 12, 2007

4 Recommendations

Following an unfavorable regulatory decision for its lead drug Provenge, biotech Dendreon (Nasdaq: DNDN) now finds itself facing more issues, as it revealed in a SEC filing earlier this week. .....

http://www.fool.com/investing/high-growth/2007/07/12/dendreo…

[Bachalor]

etliche sprechen nicht gut über dndn
was macht die aktie




möchte zu gerne mqal mäuschen sein
was sich da abspielt

[edelupolino]

Antwort auf Beitrag Nr.: 30.669.095 von surga am 13.07.07 13:47:34

wie Motley Fool sagt, ists wohl nichts gefährliches:

...When you're a money-losing development-stage drugmaker, every dollar counts to help stave off a cash crunch, but even the worst-case outcome with this SEC inquiry (which would be years in the making) won't shape the future of the drugmaker and will be inconsequential to Dendreon investors when compared with the pivotal interim phase 3 Provenge study results coming up next year.

...sondern zu erwartendes.

Übrigens...dann müssen wir ja garnicht mehr so lange warten...

@ GuHu : schönen urlaub; ich fahr übrigens morgen ins Altmühltal - und geh auch nur selten an den pc...

[NoSelters]

SEATTLE, July 17, 2007 /PRNewswire-FirstCall via COMTEX/ --Dendreon Corporation

SEATTLE, July 17, 2007 /PRNewswire-FirstCall via COMTEX/ --
Dendreon Corporation
(Nasdaq: DNDN) today announced the Company will release its second quarter
financial results on Tuesday, August 7, 2007. Company management will host a
conference call at 1:30 PM Pacific Time to provide a review of its second
quarter financial results and the following recent events.

* The Company received confirmation that the U.S. Food and Drug
Administration will accept either a positive interim or final analysis of
survival from its ongoing IMPACT study to amend the Biologics License
Application for Provenge(R) (sipuleucel-T), its investigational active
cellular immunotherapy for metastatic, androgen-independent prostate cancer.

* The Company continues to have strong patient enrollment in its Phase 3
IMPACT study, which is on track for completion of enrollment this year.

* The Company completed a financing that resulted in gross proceeds of
approximately $85 million from a convertible senior subordinated notes
offering.

* Presented data from an analysis of Phase 3 Studies (D9901 and D9902A)
that showed a prolonged survival benefit for patients who were initially
treated with PROVENGE who then went on to receive docetaxel chemotherapy after
disease progression.
Time: 4:30 PM ET /1:30 PM PT
Date: Tuesday, August 7, 2007
Dial-in: 1-800-665-0430 (domestic) or [phone] (international)
Webcast: http://www.dendreon.com (homepage and investor relations section)

[NoSelters]

Antwort auf Beitrag Nr.: 30.732.147 von NoSelters am 17.07.07 19:22:19

@ Hakur

Falls Du ne (neue) Bewertung des aktuellen Charts hättest würd ich mich über ein kurzes Statement von Dir freuen.(gerne auch BM)

Danke vorab.

No

[Bachalor]

[NoSelters]

Hmmmh....
Urlaub,...Schwimmbad,...Baggersee,...Biergarten...

1000 Gründe mal vom Rechner wegzubleiben,...aber...
spannender ists halt mit DNDN.


No

[NoSelters]

[euroturk]

was ist los keiner mehr da ???????
gruß an alle

[Poppholz]

Antwort auf Beitrag Nr.: 30.766.532 von euroturk am 19.07.07 21:24:03

schon noch da, aber es passiert ja nichts.

[LaPlue]

Antwort auf Beitrag Nr.: 30.769.327 von Poppholz am 20.07.07 09:01:25

Spätestens am 7. August wissen wir mehr.....

[Bachalor]

Antwort auf Beitrag Nr.: 30.766.532 von euroturk am 19.07.07 21:24:03

[BrauchGeld]

http://www.pharmalot.com/2007/07/dendreon-provenge-and-confl…

Dendreon, Provenge And Conflicts Of Interest
July 20th, 2007 4:36 pm By Ed Silverman

[hakur]

Antwort auf Beitrag Nr.: 30.732.230 von NoSelters am 17.07.07 19:26:51

@ NoSelters
hat etwas gedauert mit dem Chart reinstellen.
Die Situation war in den letzetn Wochen zwar immer im grünen Bereich jedoch nicht unbedingt zwingend !
Jetzt hat sich in den letzten 12 Handelstagen so meine ich ein bullisch fallender Keil ausgebildet. Die obere Begrenzungslinie dieses fallenden Keils bildet interessander Weise paralelle Linien mit einem fallenden Kanal (blaugrün, Mai bis heute) dessen obere Begrenzung vieeel Raum lässt. Von der unteren Begrenzung hat sich der Kurs schon etwas abgestezt.
Kann jeder selbst interpretieren denke ich.
Bin jetzt bald auch im Urlaub,

so looong

[URL]http://www.tradesignalonline.com/content.asp?p=wpa/tsb/default.asp&fcid=2239215[/URL]
[URLChart öffnen]http://www.tradesignalonline.com/content.asp?p=wpa/tsb/default.asp&fcid=2239215[/URL]

[NoSelters]

Antwort auf Beitrag Nr.: 30.824.703 von hakur am 24.07.07 11:46:12

@ hakur

Danke Dir recht herzlich und wünsche Dir einen schönen Urlaub!

Grüssle...

No

[NoSelters]

Puuuh...

Die GPC Longies sind ganz schön geschlachtet worden

12:0 gegen eine Zulassung von Satraplatin!!

Dürfte das Ende einläuten.

Biotechs halt....


No

[surga]

Antwort auf Beitrag Nr.: 30.772.899 von Bachalor am 20.07.07 12:55:01

Dying Patients Fight the FDA

http://www.businessweek.com/technology/content/jul2007/tc200…

......

Provenge Firestorm

Even cancer specialists, who often seek compassionate use programs for their patients, aren't keen on expanded access. "I understand emotionally why patients would want this right, but the issues surrounding experimental drugs are very complex, and I think this could potentially backfire," says leading oncologist Dr. George Demetri of the Dana-Farber Cancer Institute in Boston. "Patients really need to know the relative benefit of a drug versus the relative risk, and expanded access could prevent them from gaining that insight."

Activist patients, however, are disinclined to wait for such data when it comes to diseases for which treatments are few to nonexistent. Prostate cancer patient advocates in particular are up in arms these days over the FDA's controversial refusal in May to approve Dendreon's (DNDN) Provenge without further clinical trials, which could take a year or more to complete. Provenge is a novel cancer vaccine meant to prime the body's immune system to attack tumors, and if approved would have been the first new treatment in more than 20 years for advanced, stage-4 prostate cancer, which is almost always fatal. Some 30,000 men die each year in the U.S. from prostate cancer.

In a trial, Provenge failed to stop the disease from progressing, but when it dug into the data it found that patients on the drug lived an average of 4.5 months longer than those on standard treatment. Despite the uneven results, an FDA advisory panel voted 13-4 in March to recommend the drug for approval, and the FDA usually follows such recommendations. So when the agency withheld approval on May 9, a firestorm erupted. Prostate cancer activists (and disgruntled Dendreon investors) have lobbied Congress, held demonstrations, and met with the FDA's Commissioner, Dr. Andrew von Eschenbach.


......

[Sung]

Antwort auf Beitrag Nr.: 30.839.407 von NoSelters am 25.07.07 09:57:32

Geschlachtet, ausgebeint und geschändet wurden wir. Manche sogar 2mal. Nein Biotech ist nicht immer so. Aber in dem Fall schon.

Ich möchte mich hier mal in aller deutlichkeit bei euch entschuldigen. Wir waren sowas von überzeugt - schlimmer gings nimmer

[hakur]

Antwort auf Beitrag Nr.: 30.865.791 von Sung am 26.07.07 20:10:52

Wow ,
das ist eine sehr selten anzutreffende honorable Reaktion!
Ich denke jeder kann mal von der Wirklichkeit überrollt werden, speziell bei Biotechs.
Klasse Haltung von Dir Sung.
Kopf hoch, die Zeit wird neue Perspektiven mit sich bringen.
Danke und schade für Euch hätte Euch ohne wenn und aber Gewinne gegönnt.
so long

[surga]

Antwort auf Beitrag Nr.: 30.865.791 von Sung am 26.07.07 20:10:52

Wir waren auch von DNDN-Zulassung überzeugt.

Leider hat FDA was zu sagen, nicht wir

Ville7 hat uns damals geraten, zumindest einen Teil zu verkaufen (Eigenkapital), was ich auch nach sehr lange zögern befolgt hatte. ich war ihm sehr dankbar darüber. Gott sei dank!

Es tut mir sehr leid, dass Euch bei GPC das auch erleben musst.

[NoSelters]

Antwort auf Beitrag Nr.: 30.865.791 von Sung am 26.07.07 20:10:52

@ sung

Hut ab !!!
Meinen grössten Respekt vor Dir!
Solche Charaktere findet man leider viel zu selten bei WO.

Good Luck ...

NoSelters

[surga]

Antwort auf Beitrag Nr.: 30.866.306 von surga am 26.07.07 20:40:52

Ich habe das Gefühl, dass hier irgendwas im Busch ist.

[NoSelters]

Antwort auf Beitrag Nr.: 30.879.867 von surga am 27.07.07 17:42:18

Denk das sind

COVERVERSUCHE der Shorties.

Gelingen aber nicht oder nur bedingt,da ihnen der kurs beim versuch größere Pakete zu erstehen steil nach oben wegläuft.

Wo soll das enden bei einem shortanteil von über 50% ??
Wie sollen die Phantomshares je "gecovert" werden??

Hat jemand ne intelligente Lösung? (ausser daß man die Fa. bewusst an die wand fährt)



Spannend bleibts auf jeden Fall....THE WAR ON DNDN....

No

[eck64]

[GuHu1]

Antwort auf Beitrag Nr.: 30.865.791 von Sung am 26.07.07 20:10:52

da bin ich mal in urlaub und dann so einen negativ knaller bei gpc.

hi sung,
bist einer der wenigen die sich entschuldigen.hoffe es hat dich nicht ganz so schlimm erwischt.

[surga]

Antwort auf Beitrag Nr.: 30.880.323 von NoSelters am 27.07.07 18:13:47

NoStelters,
Vielen Dank für Deine Aufkärung
Ist sehr interessant zu beobchten, was da abspielt

[Sung]

Antwort auf Beitrag Nr.: 30.881.283 von GuHu1 am 27.07.07 19:25:38

Doch hat es und zwar richtig.
Eines könnt ihr euch sicher sein. Ihr bekommt mit DNDN noch eine Chance, siehe Northwest Biotherapeutics. Bei GPC scheint der Ofen ganz aus zu sein. Da sieht man auch mit dem größten Optimismus nur schwarz am Horizont.

Ehrlichkeit ist das A und O auch wenn es die Börse manchmal nicht wahrhaben mag. Bei GPC wurden anscheinend Fehler gemacht die man nicht mehr geradebiegen kann, siehe die Sammelklage.

[hakur]

Q Alle
hier könnt Ihr als einer der ersten die neue webseite vom IV board sehen ist noch nicht öffentlich !
Hat tradn_n_mowin persönlich gebaut.
Lässt für die Zukunft hoffen meine ich
so jetzt bin ich auch wechh
so loong

http://users.tellurian.net/tom/caretolive/index.htm

[GuHu1]

Antwort auf Beitrag Nr.: 30.883.305 von Sung am 27.07.07 22:23:50

@sung
scheiße, das mit den verlusten tut mir leid.

die lage bei gpc kann ich schlecht beurteilen.
du hast recht, DNDN hat alle chancen provenge als erstes präparat mit erheblicher lebensverlängerung und geringen nebenwirkungen an den markt zu bringen.

@ No
dndn wird durch die für mich überraschende entwicklung bei gpc noch viel interesanter als zuvor.

[GuHu1]

Antwort auf Beitrag Nr.: 30.883.768 von hakur am 27.07.07 23:01:02

ha, die ist auch nicht schlecht

[GuHu1]

Hab noch mal was nettes gefunden:

Letter to the IV board

To The Investor Village Board,

We are now at a crossroad. 30,000 men will die each year while the FDA waits for more data on Dendreon's safe and effective immune boosting prostate cancer treatment, Provenge.

We are reaching out to all groups nationwide to join us in our battle. We in turn will be there for you when you call upon us to fight your battles against Big Government, Big Pharma and the other forces that are often working against the benefit of mankind (see link below).

http://www.arighttolive.com/DysfunctionattheFDA.pdf

As one group we can do nothing. With the power of the internet, we can network together and become a force they will have to reckon with.

We don't care how long it takes or what hurdles we have to overcome. We only care about one thing, OUR QUALITY OF LIFE. NOW! Our voices will be heard. PLEASE JOIN US IN THIS FIGHT.

Our first course of action is to get Provenge Approved NOW! We are in the process of planning a rally in the Washington, D.C. area on September 18, 2007 to coincide with Prostate Cancer Awareness Week.

Rally details are not finalized. Please visit http://www.arighttolive.com/ for up to date information and to see what you can do to help.

To all who participate, we send you our heartfelt thanks. Please forward to everyone you know. In the words of Ben Franklin at the signing of the Declaration of Independence, “We must all hang together, or assuredly we shall all hang separately.”

[Bachalor]

ruhig hier

alles wartet und wartet

hoffentlich gibt es nicht erwachen wie bei gpc

von seitens der fda


wenn nicht,dann

[GuHu1]

Antwort auf Beitrag Nr.: 30.891.802 von Bachalor am 28.07.07 11:53:07

alles wartet und wartet
hoffentlich gibt es nicht erwachen wie bei gpc
von seitens der fda

ach lass uns noch ein bischen warten.
ich habe mittlerweile meine eigene herangehensweise und wenn du NO`s darstellung zur situation bei dndn dazu nimmst, könnten wir noch üppig dafür belohnt werden.

[GuHu1]

IV Board:

Huckman blog
A non-profit group calling itself "CareToLive" is suing FDA Commissioner Dr. Andrew von Eschenbach over the recent delay in the potential approval of Dendreon's Dendreon CorpDNDN
7.79 0.12 +1.56%


Quote | Chart | News | Profile | Add to Watchlist
[DNDN 7.79 0.12 (+1.56%) ] Provenge.

An FDA spokesperson says the agency doesn't comment on pending litigation.

The lawsuit accuses the Commish of "arbitrarily and capriciously" denying immediate approval of Provenge and putting the lives of tens of thousands at stake.

The plaintiffs want a federal judge in Ohio where the case was filed to order the drug be made available right away. The suit also names another FDA staffer and a controversial doctor who was on the outside panel that reviewed Provenge.

CareToLive calls this action unprecedented. What else would you expect from the most hotly-debated, dramatic drug approval pathways I've ever seen?

[Cyberhexe]

Antwort auf Beitrag Nr.: 30.883.305 von Sung am 27.07.07 22:23:50

Ehrlichkeit ist das A und O auch wenn es die Börse manchmal nicht wahrhaben mag. Bei GPC wurden anscheinend Fehler gemacht die man nicht mehr geradebiegen kann, siehe die Sammelklage.

...die Sammelklagen sind sicherlich kein Indiz dafür, dass Satraplatin chancenlos ist - bei Dendreon und vielen anderen Firmen in US gabs/gibts die nämlich auch.
Allerdings spricht gegen Satraplatin die geringe Wirksamkeit, während bei Provenge die Wahrscheinlichkeit mehr als gut ist, dass sich die in den bisherigen Studien gezeigte Wirksamkeit in D9902B bestätigt. Wenn ja, dann wird Provenge zugelassen!

[Sung]

Antwort auf Beitrag Nr.: 30.941.957 von Cyberhexe am 30.07.07 20:14:59

Wie siehst Du Dendreon im Gegensatz zu Northwest Biotherapeutics?
Im Moment hat NWBO ja in der Schweiz eine Genehmigung für DCVax-Brain (noch keine Marktzulassung). Indikation HPRC soll folgen.
Sind beide da nicht Konkurrenten?

[GuHu1]

neue jobs ausgeschrieben :

Buyer Seattle WA Regular Full Time
Quality Assurance Associate II Seattle WA Regular Full Time
Senior SAS Programmer Seattle WA Regular Full Time

[NoSelters]

Antwort auf Beitrag Nr.: 30.941.957 von Cyberhexe am 30.07.07 20:14:59

Ein herzliches Hallo...

Schön,mal wieder von Dir zu hören!

Wilde Zeiten momentan,...seis bei Elan oder DNDN.
Ich halte immer noch in voller Höhe.
(Sekt oder Selters...gg...)

No

[surga]

Antwort auf Beitrag Nr.: 30.941.957 von Cyberhexe am 30.07.07 20:14:59

4-12-07 lawsuit filed against FDA/VonE


......
COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF
Plaintiffs Association of American Physicians and Surgeons, Inc. (“AAPS”), Concerned
Women for America (“CWA”), Family Research Council (“FRC”), and Safe Drugs for Women
(“SDW”) seek declaratory and injunctive relief based on the following allegations.

......


http://www.aapsonline.org/judicial/pb-fda-4-12-07.pdf

[hri]

BusinessWeek
Pressure for Provenge Approval
Tuesday July 31, 8:08 am ET
By Catherine Arnst


A group representing both prostate cancer patients and disgruntled investors is suing the Food & Drug Administration's commissioner and others involved in the agency's unexpected decision to disapprove a proposed vaccine called Provenge.
ADVERTISEMENT


The lawsuit, filed July 30 in an Ohio federal court by CareToLive.com, marks the latest salvo in an acrimonious campaign to gain access to the Dendreon (NasdaqGMNDN - News) vaccine after the FDA concluded in May that existing data did not warrant approval. New Jersey-based nonprofit Care To Live, started solely to lobby for Provenge, represents not only prostate cancer patients and their families, but Dendreon investors who saw their shares drop more than 60% within a day after the FDA's May 9 decision.

Recommended, but Not Approved

The FDA's move surprised some observers because an advisory panel made up of outside experts voted in March to recommend the drug's approval by a 13-to-4 margin. The panel also unanimously agreed that Provenge was safe. The agency usually follows the advice of its advisory panels, but this is a complicated situation: Provenge is the first drug to come before the FDA that would prompt the body's own immune system to fight tumors.

Although many scientists say such vaccines hold great promise, none have yet shown unequivocal proof that they're effective. Provenge, for example, did not shrink prostate tumors, the primary goal of its clinical trial. However, patients on the drug did live an average of four-and-a-half months longer than those on the standard treatment, adding what's considered a significant amount of time for very sick patients. But Dendreon's small clinical trial was not designed to measure survival, and the FDA rarely gives its approval under such circumstances. Dendreon is hoping to win approval after submitting the results of a larger trial that is designed to measure survival, but that data likely won't be available until 2010.

Conflicts of Interest?

The only treatment currently available for advanced prostate cancer, a disease expected to kill 30,000 men in the U.S. this year, is so toxic that many patients refuse it. Consequently, many were hopeful that the FDA would have O.K.'d Provenge by now. The delay has infuriated many patient advocates and investors, who have responded by lobbying Congress, holding rallies, taking out newspaper ads, and accusing the dissenting members of the advisory committee of conflicts of interest.

The lawsuit steps those efforts up a notch, naming three high-ranking federal officials: Dr. Andrew von Eschenbach, FDA Commissioner; Michael Leavitt, Secretary of the Health and Human Services Dept.; and Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products. The suit also targets Dr. Howard Scher, one of the four members of the FDA advisory panel to vote against recommending Provenge for approval. Scher, a prominent prostate cancer specialist at Memorial Sloan-Kettering Cancer Center in New York, has drawn so much ire that he had bodyguards protect him at a recent oncology meeting.

The Care To Live suit follows a more sweeping action taken by another patient advocacy group, the Abigail Alliance for Better Access to Developmental Drugs, which is suing for broader access to experimental drugs (see BusinessWeek.com, 7/25/07, "Dying Patients Fight the FDA"). That lawsuit is currently being considered by the federal circuit court in Washington, D.C. If the Abigail Alliance prevails, it could establish a constitutional right to experimental drugs.

Care To Live describes itself as a nonprofit association of prostate cancer patients, families, doctors, investors, and patient advocates. The group and its lawyer did not respond to requests for an interview, but the lawsuit requests that the FDA be enjoined from denying marketing approval for Provenge. The group also wants the agency to declare that its failure to approve Provenge was due to improper actions taken by Scher and Pazdur. The FDA does not comment on pending litigation and Sloan-Kettering declined to comment.

[hri]

sieht so aus als hätte die fda provenge auf der agenda gehabt :


Dockets Management

Dockets Entered On July 30, 2007


Docket # Title

2004D-0333 Emergency Use Authorization of Medical Products
2005N-0329 Designation of New Animal Drugs for Minor Uses or Minor Species
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0108 Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
2006N-0283 Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
2006N-0362 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
2007D-0201 Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
2007D-0213 Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
2007D-0252 Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters - Premarket Notification Submissions 510(k)s
2007D-0290 Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
2007N-0050 Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study
2007N-0155 Defining and Implementing Quality in Clinical Investigations: From Design to Completion; Public Workshop
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
2007N-0278 Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments
2007P-0033 Amend the Nutrition Facts label on food products as it relates to trans fats
2007P-0044 Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
2007P-0296 Request that the FDA requires labeling changes for Skelaxin (active ingredient metaxalone) as set forth in the proposed revised packaging insert
2007P-0297 Request to reconsider the failure to approve Provenge

[GuHu1]

Antwort auf Beitrag Nr.: 30.950.685 von hri am 31.07.07 14:20:56

http://www.fda.gov/ohrms/dockets/dailys/07/july07/073007/073…

Dockets Management


Dockets Entered On July 30, 2007



Docket # Title
.
.
.
2007P-0297 Request to reconsider the failure to approve
Provenge

[Aurelian]

Antwort auf Beitrag Nr.: 30.941.957 von Cyberhexe am 30.07.07 20:14:59

das du dich so lange nicht hast blicken lassen, zeugt von echter charakterstärke. nachdem du diesen wert unmittelbar vor dem kursverfall ja noch immer zum kauf \"empfohlen\" hast, finde ich es unheimlich interessant, dass gerade du von ehrlichkeit sprichst. zumal du dann erst mal abgetaucht bist. chapeau, kann ich da nur sagen.
im oec thread hat sich teilnehmer stellenweise als schweine bezeichnet, weil sie an diesen wert geglaubt haben. eine briefkastenfirma sollte es sein. mittlerweile ist ein multimilliardär in diese briefkastenfirma eingestiegen sein. und plötzlich war sie auch da verschwunden.

ohne worte, echt!

@hri: du treibst dich ja wirklich überall rum

[surga]

Antwort auf Beitrag Nr.: 30.965.206 von GuHu1 am 01.08.07 12:36:55

"Provenge Now" Shirts For Sale

[GuHu1]

Antwort auf Beitrag Nr.: 30.965.321 von Aurelian am 01.08.07 12:44:13

hey, bleib locker.
ich bin froh das hier etwas mehr ruhe eingekehrt ist.
nachtreten ist nicht erwünscht.
ich kann dir viele beispiele von falschen einschätzungen präsentieren, doch ob CH hier letztlich falsch liegt wird sich noch zeigen.

der ball für dndn ist immer noch im spiel!

[Poppholz]

Antwort auf Beitrag Nr.: 30.965.321 von Aurelian am 01.08.07 12:44:13

Deine Äußerung ist wohl ein wenig zu einseitig dargestellt.

Cyberhexe hat Ihre Einschätzung schon bei einem sehr niedrigen Kursniveau dargestellt und die darauf folgenden Ereignisse haben Ihr auch Recht gegeben.

Das die FDA letztendlich doch eine andere (nicht nachvollziehbare) Entscheidung getroffen hat, ist von vielen so nicht erwartet worden.

Cyberhexe ist in diesem Thread nicht als "Dummpusherin" aufgefallen, sondern hat Ihre Meinung zu DNDN und Provenge dargestellt und auch sehr viel Fachwissen in diesem Zusammenhang an den Tag gelegt.

Ich bin sehr froh, dass Sie wieder hier ist und uns an Ihrem Wissen und Ihrer Einschätzung teilhaben läßt.

Es steht jedem frei, dieser Auffassung zu folgen oder genau das Gegenteil zu machen. Jeder ist für seine Kohle selbst verantwortlich.

[GuHu1]

Antwort auf Beitrag Nr.: 30.979.136 von Poppholz am 02.08.07 09:30:38

sehe ich auch so

[GuHu1]

netter situationsbericht:

http://seattletimes.nwsource.com/html/businesstechnology/200…

[GuHu1]

Antwort auf Beitrag Nr.: 30.982.561 von GuHu1 am 02.08.07 12:33:37

viel zu lesen:

http://www.investorvillage.com/smbd.asp?mb=971&mn=148009&pt=…

[Cyberhexe]

Antwort auf Beitrag Nr.: 30.965.321 von Aurelian am 01.08.07 12:44:13

...zu welchen Aktien ich mich äussere oder eben nicht, werde ich mich nicht rechtfertigen...
http://www.wallstreet-online.de/dyn/community/thread.html?th…

...und deine Verleumdungen und Lügen werden mich nicht dazu verleiten, mich deinem Niveau in irgendeiner Form anzunähern!

[Cyberhexe]

Antwort auf Beitrag Nr.: 30.983.009 von Cyberhexe am 02.08.07 13:01:11

...nu ja, der angebliche Einstieg eines Milliardärs hat dieser Frick-Empfehlung zu einer riesigen Kursrally verholfen:

http://aktien.wallstreet-online.de/7228/chart.html?inst_id=7…

Und meine Warnung vor diesem Luftschloss Anfang 2006 war natürlich völlig unbegründet.

Komischerweise ist meine Abstinenz für diejenigen Teilnehmer, die auf begründete Kritik mit Hexenverbrennungen und dergleichen reagiert haben, erneut Anlass zur Beschwerde!

[NoSelters]

http://www.paperboy.nl/?PID1=B%3E%27S4LIN2%5EUZ3EOE%3AO%23BR…



NoSelters

[GuHu1]

cramer dreht am rad

http://www.cnbc.com/id/15840232?video=452808336

[GuHu1]

keine ahnung ob es jemanden interessiert.

SEATTLE, July 17, 2007 – Dendreon Corporation (Nasdaq: DNDN) today announced the Company will release its second quarter financial results on Tuesday, August 7, 2007. Company management will host a conference call at 1:30 PM Pacific Time to provide a review of its second quarter financial results and the following recent events.

The Company received confirmation that the U.S. Food and Drug Administration will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to amend the Biologics License Application for Provenge® (sipuleucel-T), its investigational active cellular immunotherapy for metastatic, androgen-independent prostate cancer.

The Company continues to have strong patient enrollment in its Phase 3 IMPACT study, which is on track for completion of enrollment this year.

The Company completed a financing that resulted in gross proceeds of approximately $85 million from a convertible senior subordinated notes offering.

Presented data from an analysis of Phase 3 Studies (D9901 and D9902A) that showed a prolonged survival benefit for patients who were initially treated with PROVENGE who then went on to receive docetaxel chemotherapy after disease progression.
Time:
4:30 PM ET /1:30 PM PT
Date:
Tuesday, August 7, 2007
Dial-in:
1-800-665-0430 (domestic) or [phone] (international)
Webcast:
www.dendreon.com (homepage and investor relations section)

[alysant]

Antwort auf Beitrag Nr.: 31.019.277 von GuHu1 am 04.08.07 12:56:37

aber mit Sicherheit, das siehst Du an der Zahl der Aufrufe !

Auch wenn Du zeitweise Alleinunterhalter bist:

Das ist einer der reizvollsten Titel überhaupt ! Ich warte nur noch auf einen Kurs von ca. Doll. 5.

Könnte allerdings sein, daß mir das Maul trocken bleibt

=====================

also nochmal:

Dienstag, 7.8., Quartalsergebnis zur Börsenzeit + Ausblick
==========================================================

gibts es positive Überraschungen, dann folgen Kursvervielfachungen und danach upgrades der Broker

alte Erfahrung

[GuHu1]

Antwort auf Beitrag Nr.: 31.033.709 von alysant am 05.08.07 15:49:26

schön zu wissen.

halte dndn auch für einen ganz heißen wert, deshalb schieb ich das eine oder andere in den thread.
was den wert besonders interessant macht ist der öffentliche druck in usa. die kämpfen echt mit allem was ihnen zur verfügung steht und ich gebe zu, dass bewundere ich auch ein bisschen.

andererseits weiss ich wie chemo einen menschen zerstören kann.
die zeit ist reif für neue wege, überreif.

[NoSelters]

Heute sind wieder Nerven gefragt....

Hat jemand ne aktuelle Chartanalyse...?...Hakur vielleicht..?

Die 7 $ sind ja hart umkämpft heute.

Grüsse aus dem Süden...

NoSelters

[GuHu1]

Antwort auf Beitrag Nr.: 31.054.070 von NoSelters am 06.08.07 18:25:56

hi No, soweit ich weiß ist hakur noch im urlaub.
die $7 waren zwar hart umkämpft, haben letztlich aber gehalten.

heute ca. 22:30 gibts den conference call, wirds was neues geben, wer weiss.

[NoSelters]

Antwort auf Beitrag Nr.: 31.062.475 von GuHu1 am 07.08.07 12:16:05

Hallo GuHu,

hoffen wir,daß mitch was positives im gepäck hat.

Gibts ne video-oder Telefonkonferenz?
Hast Du vielleicht auch nen Link?
Danke vorab.

Gruss

NoSelters

[alysant]

Antwort auf Beitrag Nr.: 31.062.475 von GuHu1 am 07.08.07 12:16:05

1.30 p.m. pacific time

ist das dann nicht + 4 eastern time =

23.30 h ?

[NoSelters]

LESENSWERT

http://www.pharmalot.com/2007/08/fda-panels-to-end-conflicts…



NoSelters

[NoSelters]

Da werden wieder einige Stopps abgefischt...

No

[GuHu1]

Antwort auf Beitrag Nr.: 31.063.473 von NoSelters am 07.08.07 13:34:33

hi no
webcast http://investor.dendreon.com/medialist.cfm,
e-mail eintragen dann vor- und nachnamen, registrieren und ab geht die post.

@alysant

sollte eigendlich passen mit 22:30, oder ich hab hier nen denkfehler.

In den USA gibt es folgende Zeitzonen:
EST: Eastern Standard Time MEZ - 6 Std
CST: Central Standard Time MEZ - 7 Std
MST: Mountain Standard Time MEZ - 8 Std
PST: Pacific Standard Time MEZ - 9 Std
Alaska MEZ -10 Std
Hawaii MEZ -11 Std

http://www.hartberger.de/neuzeitusa.htm

[NoSelters]

Antwort auf Beitrag Nr.: 31.070.696 von GuHu1 am 07.08.07 21:17:17

D A N K E

Ich mein auch 22.30 Uhr MEZ passt.

No

[GuHu1]

Antwort auf Beitrag Nr.: 31.070.696 von GuHu1 am 07.08.07 21:17:17

da fällt mir ein, vieleicht müsst ihr euch vorher noch für den e-mail alerts registrieren lassen, weiß ich aber nicht genau.

http://investor.dendreon.com/distlist.cfm?header=News

so und nun bin ich mal gespannt ob das ne luftnummer wird, oder ob heut was neues bekanntgegeben wird.
ist einiges denkbar.

[GuHu1]

Antwort auf Beitrag Nr.: 31.069.178 von NoSelters am 07.08.07 19:44:27

LESENSWERT
ja ist es und das auch:

http://blogs.webmd.com/cancer-treatments-options/2007/08/pro…

[NoSelters]

Antwort auf Beitrag Nr.: 31.071.052 von GuHu1 am 07.08.07 21:42:58

Yep,....

...Druck wird grösser und grösser.

An die Story hängen sich hoffentlich noch viele dran...am besten noch grosse TV-Sender...

"The Battle is going on..."

No

[NoSelters]

Naja,...über die Wahl der musikalischen Hintermalung kann man streiten..

Hoffentlich hat Mitch gleich mehr DAMPF...

No

[GuHu1]

Antwort auf Beitrag Nr.: 31.071.734 von NoSelters am 07.08.07 22:25:25

so ein mist komm selber nicht rein, also no pass schön auf!

[NoSelters]

Antwort auf Beitrag Nr.: 31.071.790 von GuHu1 am 07.08.07 22:28:20

Shit.... nach ner Minute flieg ich wieder raus...3x schon

[NoSelters]

Antwort auf Beitrag Nr.: 31.071.862 von NoSelters am 07.08.07 22:32:16

...und aus WO auch....

Computi spinnt!

[Poppholz]

würde mich über eine kurze Zusammenfassung freuen.

Habe leider nicht die Möglichkeit reinzuhören.

Danke

[Poppholz]

Dendreon steigert Umsatz und reduziert Verlust

Seattle (aktiencheck.de AG) - Die amerikanische Dendreon Corp. (ISIN US24823Q1076/ WKN 615606) veröffentlichte am Dienstag nach US-Börsenschluss die Zahlen zum zweiten Quartal 2007. Das Biotechnologie-Unternehmen konnte dabei infolge steigender Umsätze den Verlust reduzieren.

Der Nettoverlust verringerte sich von 25,1 Mio. Dollar oder 35 Cents je Aktie auf 22,2 Mio. Dollar bzw. 27 Cents je Aktie. Analysten hatten im Vorfeld einen Verlust von 30 Cents je Aktie erwartet.

Daneben stiegen die Umsatzerlöse von 78.000 Dollar auf nun 0,5 Mio. Dollar. Die Analysten hatten im Vorfeld einen Umsatz von 0,2 Mio. Dollar erwartet.


Für das laufende dritte Quartal 2007 rechnen die Analysten mit einem Verlust von 25 Cents je Aktie bei Umsätzen von 0,13 Mio. Dollar.


Die Dendreon-Aktie schloss heute an der NASDAQ bei 7,19 Dollar (+0,56 Prozent). (07.08.2007/ac/n/a)


http://www.wallstreet-online.de/nachrichten/nachricht/212860…


Dies ist doch schon gar nicht so schlecht.

[Poppholz]

Antwort auf Beitrag Nr.: 31.072.179 von Poppholz am 07.08.07 22:50:43

mehr als doppelt so viel Umsatz und weniger Verlust, wie von den Analysten erwartet.



Zugegeben, der Umsatz ist nicht so berauschend (da setzen einige hier an der Börse am Tag mehr Kohle um), aber die Richtung stimmt.

Weiß jemand wie viel Kohle die noch zum "vorstrecken" liegen haben?

[Poppholz]

Short Interest
| Full listShort Interest Date:Jul 10 2007
Short Interest Shares:42,339,655
Short Interest Ratio:5.5
Float:82,206,181
Short Interest as a % of Float:51.5%
Average Daily Volume:13,373,400
Outstanding Shares:83,505,892

http://money.cnn.com/quote/quote.html?symb=DNDN

Kann das sein? Sind am 10. Juli 51,5% der Aktien SHORT gewesen?

[NoSelters]

Antwort auf Beitrag Nr.: 31.072.770 von Poppholz am 08.08.07 00:17:46

Ja,ist leider so....

No

[GuHu1]

Antwort auf Beitrag Nr.: 31.074.416 von NoSelters am 08.08.07 09:42:24

@poppi
ich kann nichts beisteuern, hatte immer wieder eine fehlermeldung beim einwählen.

@no
wieso leider? wir wissen das doch und warten auf den tag an dem mit gleicher münze zurückgezahlt wird.
ich bleibe derzeit noch zuversichtlich.

[Poppholz]

Antwort auf Beitrag Nr.: 31.074.731 von GuHu1 am 08.08.07 10:01:13

ich gehe auch davon aus, dass die geshorteten Aktien ja auch mal wieder glatt gestellt werden müssen und wenn dann keiner mehr da ist, der verkaufen will, dann kommt der Kurs richtig in Fahrt.

(was das angeht ist der Kurs momentan doch noch richtig gut)

[NoSelters]

Antwort auf Beitrag Nr.: 31.074.731 von GuHu1 am 08.08.07 10:01:13

Leider...

...weil ich keine Idee habe wie über 50% der regulären Shares gecovert werden sollen zumal noch eine grosse Anzahl "Phantomshares" in Umlauf sind.
Meiner Ansicht nach gibt es jetzt und auch bei wesentlich höheren Kursen nicht genügend Verkäufer um auch nur annähernd glatt zu stellen.
Das Blutbad bei einem Shortsqueeze wäre gigantisch.

Ein konsequentes Eingreifen der SEC wäre eine Lösung...aber....Korruption wo man hinschaut.

Und solange Mitch einen Alleingang anstrebt(keine Partnerschaft) bläst uns der Wind voll entgegen.

Dennoch...die Hoffnung stirbt zuletzt!!

Gruss

No

[Poppholz]

Antwort auf Beitrag Nr.: 31.077.968 von NoSelters am 08.08.07 13:07:08

bei einem SHORTSQUEEZE wäre ich natürlich bereit meine Aktien ab €80,00 auf den Markt zu werfen, damit die armen Shorties nicht in Bedrängnis kommen.



(ich zahle ja schließlich auch Steuern)

[NoSelters]

Antwort auf Beitrag Nr.: 31.078.090 von Poppholz am 08.08.07 13:15:06

...wäre auch ein VK-Preis bei dem ich schwach werden würde.

aaabeeer....Steuerfrei... (ab 03/08)

Schaun ma mal....

No

[SFJL]

Mologen...mit MIDGE das erste Vaccin zur Krebstherapie!

[[KERN]Codex]

Wenn sich das rumspricht gibt es kein Halten mehr!

[GuHu1]

Antwort auf Beitrag Nr.: 31.078.231 von NoSelters am 08.08.07 13:23:09

war ja gestern nicht dabei, aber könnt ihr das folgende aus dem IV board bestätigen?

3 in 1. (Great news for DNDN shareholders)
Mitch Gold said 3 things in one sentence yesterday.
1. the company is Clearly on track for regulatory pathway to get provenge------in the U.S.
2. The company is STARTING TO GET THE DRUG APPROVED OVER SEAS.
3. the company is looking for partnership(First time Gold said it officially)

This was said in the 3rd minute of CC. by Gold.
I am surprised that this news did not get much attention.
Why would a C.E.O. mention partnership or overseas approval if there would be no such thing in the works?
He could lose his job and go to jail for misleading share holders according to Sarbane Oxly law.
I think Gold is on to something.
He just can not come out and give you the details until the deal is finalized.
http://www.investorvillage.com/smbd.asp?mb=971&mn=149174&pt=…

[franz991]

Der Weg zum Konkursrichter ist nicht mehr weit.
Baut weiter auf diesen Luftschloss.

[NoSelters]

Antwort auf Beitrag Nr.: 31.086.303 von GuHu1 am 08.08.07 20:29:19

Hi GuHu,

ja hat mitch so gesagt.
Kam aber irgendwie unspektakulär und trocken rüber.

Hmmmmh... im nachhinein betrachtet allerdings...Die aussage hat was.
Denke das zeitfenster für ein US-approval beträgt noch max. 1 jahr.

Und die möglichkeit der bekanntgabe einer row-partnership ist jederzeit gegeben.

Immer vorrausgesetzt... PROVENGE WORKS !!

Aber das wissen/glauben/hoffen wir ja alle.

Die spannung steigt jedenfalls weiter....wie der kurs heut auch.



No

[NoSelters]

Antwort auf Beitrag Nr.: 31.088.042 von franz991 am 08.08.07 22:37:25

[Poppholz]

Antwort auf Beitrag Nr.: 31.088.042 von franz991 am 08.08.07 22:37:25

Danke auch für Deine Meinung.

[NoSelters]

Hmmmh...ANALysten halt...

http://www.finanztreff.de/ftreff/news,id,27285784,sektion,em…

Ich persönlich nimms mal als "Kaufempfehlung"

No

[GuHu1]

http://www.fda.gov/ohrms/dockets/dockets/07p0297/07p-0297-cp…

man kanns ja mal versuchen.

[GuHu1]

Antwort auf Beitrag Nr.: 31.088.042 von franz991 am 08.08.07 22:37:25

hui das ist ja mal ein tiefschürfender beitrag.
das hab ich doch schon mal gehört, der das sagte ist vor kurzem mit seinem invest vor die wand gefahren.tztztz

[Poppholz]

Antwort auf Beitrag Nr.: 31.104.658 von GuHu1 am 09.08.07 22:02:29

ich denke auch.

Die FDA wird dadurch wahrscheinlich nicht unbedingt in einer Ablehnung bestärkt.

[GuHu1]

auch recht interresant.

http://onctalk.com/?p=684

__________________________________________________________

Thestreet.com has a buy rating on DNDN

[GuHu1]

irgendwie ist das verkehrte welt.
letzte woche kriselt es an allen ecken und enden ( markttechnisch ) aber dndn erweist sich als relativ festes investment.

was erwartet uns bei positiven news, mag ich mir gar nicht ausmalen.
sei es drum, kann eh noch dauern bis da was positives kommt, oder.

übrigens haben sich einige lustig über die aktivitäten der us "klein"investoren gemacht.
das war kein strohfeuer, die kämpfen auf allen fronten weiter, AMMASS ist ein solcher ( Arnie Mass ).

http://www.chicagotribune.com/news/nationworld/chi-drugs13au…

[NoSelters]

Antwort auf Beitrag Nr.: 31.145.719 von GuHu1 am 13.08.07 20:29:21

Bitte nochmal...

Hab kein password für chicago tribune...

Danke !

Gruss

No

[GuHu1]

Antwort auf Beitrag Nr.: 31.145.932 von NoSelters am 13.08.07 20:49:18

http://www.chicagotribune.com/news/nationworld/chi-drugs13au…

falls es nicht geht der text folgt, hab den reinkopiert:

A fight to give hope to the terminally ill
Patients, advocates want greater access to experimental drugs

By James Oliphant | Washington Bureau
August 13, 2007

WASHINGTON - Arnie Mass is marching on Washington next month.

But the retired stockbroker, who lives in Highland Park, isn't lining up for a political cause; he plans on doing some in-person lobbying at the doorstep of the Food and Drug Administration. Mass and his fellow protesters want an anti-cancer treatment approved by the FDA. And when do they want it? Now.

The treatment Mass is stumping for is called Provenge, and it's billed as a vaccine to help treat prostate cancer. It has been stalled in what critics say is the FDA's byzantine drug-approval process. Mass and his organization, CareToLive, have had enough. They've launched Web campaigns and taken out full-page newspaper ads to make their case. Coming to Washington is the next step.

Their case is this: Terminally ill patients, especially those who may die within months, have a right to experimental drugs. While Provenge has been wending its way through the FDA's chutes and ladders, Mass' group says, thousands of men have died. The disease claims 30,000 men annually.

"If you have a right to die," Mass says, "you surely have a right to live."

But the influential District of Columbia federal appeals court, which hears appeals concerning federal agencies, recently ruled that the terminally ill are not constitutionally entitled to experimental drugs outside the normal FDA approval process. The question could end up before the Supreme Court.

The lawsuit against the FDA was brought in 2003 by a group known as the Abigail Alliance. Its founder, Frank Burroughs, lost his daughter Abigail, 21, to cancer of the head and neck in 2001. Abigail was denied experimental drugs, and since her death, Burroughs has been working to get unapproved treatments into the hands of the terminally ill before the FDA approves them for the market.

"We're really dumbfounded," Burroughs said of last week's ruling. "We have a lot of cancer patients out there who aren't happy."

Part of Burroughs' frustration stems from the fact that a three-judge panel of the same appeals court ruled last year that the terminally ill did indeed have a constitutional right to experimental treatments. The FDA asked the full appeals court to reconsider the decision, which it did, voting 8-2 to side with the government.

The dissenting judges wrote that "the court's opinion reflects a flawed conception of the right claimed by the Abigail Alliance ... and a stunning misunderstanding of the stakes."

If the case were to reach the high court, it would undoubtedly be greeted with skepticism. A majority of the increasingly conservative body views the creation of new constitutional rights with grave suspicion.

But there's no question that the issue hits a nerve with the terminally ill or those who have lost loved ones to cancer or other diseases. Burroughs points to a poll taken last year by the National Consumers League, which concluded that a majority of Americans support broader access to experimental treatments, even if they carry additional risks.

The central question, Burroughs says, is whether terminal patients will be given the chance to take those risks. "Whose decision is it anyway?" he asked.

Today, typically only those who have been accepted into clinical trials have access to experimental therapies. And the three-stage approval process can take up to 10 years. Occasionally, pharmaceutical companies make some unapproved treatments available to terminal patients on an emergency "compassionate use" basis.

Doctors, drugmakers resist

But the drugmakers rarely manufacture more of an expensive, unapproved drug than needed to complete clinical trials.

The FDA recently announced new regulations that could make experimental drugs more widely available, but those rules are not finalized.

One presidential candidate, Sen. Sam Brownback (R-Kan.), co-sponsored a bill in 2005 to increase access to such medications, but it went nowhere. Given that the Lance Armstrong Foundation, named after the cancer-surviving Tour de France champion, is sponsoring a presidential debate in Iowa later this month, it could surface as a campaign issue.

The drug industry has resisted any government mandate to provide experimental treatments to patients, pointing to ethical issues involving unapproved uses of drugs and concerns over whether patients provide informed consent.

"Our position is that it should be left to the individual companies to make that decision," said Alan Goldhammer, vice president of regulatory affairs for Pharmaceutical Research and Manufacturers of America, the powerful pharmaceutical trade group.

A fight to give hope to the terminally ill
Patients, advocates want greater access to experimental drugs

By James Oliphant | Washington Bureau
August 13, 2007

WASHINGTON - Physicians, too, are concerned about what some opponents to the proposal call a drug "free-for-all." Allen Lichter, chief executive of the American Society of Clinical Oncologists, worries about the effect looser restrictions would have on clinical trials. There's only so much of any experimental drug to go around, he said, and having a treatment available to some might persuade others to avoid the trials altogether, where they might be treated with placebos.

"We don't believe the solution is to open the floodgates," Lichter said.

The Abigail Alliance wants the FDA to allow terminal patients to approach drugmakers after a treatment has been certified safe for human testing, during the so-called Phase I of the approval process.

"We're not asking for these Phase I drugs to be available to the general public," said the alliance's lawyer, Paul Kamenar of the Washington Legal Foundation, an anti-regulation group. "These people have three to six months to live. Their doctors have said they're at the end of the line."

And, Kamenar noted, every drug to which the Alliance has sought early access in the past few years was ultimately approved by the FDA.

FDA deals drug a setback

Provenge has already been through all three phases of the FDA's process. In March, an FDA advisory committee approved the treatment, which infuses the body's immune system with an agent to combat prostate cancer cells.

But in May, the agency denied approval, saying more data was needed. That could mean a three-year wait.

The decision did not sit well with Bruce Tower. The 59-year-old former marketing executive from Dallas, who suffers from prostate cancer, recently completed a clinical trial for Provenge after enduring every standard cancer protocol available, including chemotherapy, radiation and hormone treatments.

For the trial, Tower flew from Dallas to New York, where cells were harvested from his blood. They were modified and then re-injected into his body three days later back in Dallas. Tower credits the therapy with improving his condition. (But because it was a double-blind trial, Tower doesn't know whether he, in fact, ever received it.) "It bought me time," he says.

It's an opportunity he believes other cancer victims facing death should have. Tower plans on joining the march in Washington next month. "I'll do anything I can," he says. "I believe it's a viable treatment. I believe it has elongated my life."

[Barcaman]

AUFWACHEN!!!


Dendreon "sell"

14.05.2007
Brean Murray, Carret & Co

Rating-Update:

New York - Die Analysten von Brean Murray,
Carret & Co stufen die Aktie von Dendreon
unverändert mit "sell" ein. Das Kursziel
werde von 1,50 auf 1,00 USD ( etwa 0,7 € )
gesenkt.


Dendreon Downgrade

24.05.2007
JMP Securities

Rating-Update:

San Francisco Die Analysten von JMP Securities
stufen die Aktie von Dendreon von "market outperform"
auf "market perform" zurück.


Dendreon "market underperform"

12.07.2007
JMP Securities

Rating-Update:

San Francisco- Die Analysten von JMP Securities
stufen die Aktie von Dendreon von "market perform"
auf "market underperform" herunter. Das Kursziel
sehe man bei 5 USD. ( etwa 3,5 € )


Dendreon: sell

Zürich 09.08.2007 -

Die Börsenanalysten der UBS stufen die Aktie
des US-amerikanischen Unternehmens Dendreon
unverändert mit "sell" ein. (... )
Das Kursziel der Aktie sehe man bei 4,50 USD.
( etwa 3 € )

Vor diesem Hintergrund bewerten die Analysten der
UBS den Anteilschein von Dendreon weiterhin mit
"sell".

[GuHu1]

Antwort auf Beitrag Nr.: 31.146.351 von Barcaman am 13.08.07 21:26:07

@barcaman
danke für den hinweis aber ich bin hellwach.

wenn du damit andere investoren abschrecken willst ist mir das scheiß egal, von mir aus sollen die verkaufen, denn der kurs von dndn wird nicht in D gemacht.
hier sind 40 millionen papiere nacked short und es besteht eine recht gute chance auf verspätete zulassung ( meine meinung ).

tja pech gehabt, ist ebend anders als bei ONA!
Bevor es peinlich wird, lass es lieber.

ach so die analysten, die haben vor dem 31.03.07 auch keinen pfifferling auf dndn gegeben, also für mich eher zweitrangig.

[GuHu1]

Hier übrigens mal ein nicht so schöner artikel.

http://www.ereleases.com/pr/20070813012.html

[Barcaman]

Antwort auf Beitrag Nr.: 31.146.548 von GuHu1 am 13.08.07 21:41:18

Hi Guhu

"Pech gehabt" gilt für die Lemminge, die auf die Lügen von
Cyberhexe, No_Selters & Co hereingefallen sind und sich
nun die Wunden ob ihrer ihrer Verluste lecken müssen.

Keine Sorge, ich bin schon wieder weg und habe überhaupt
nicht vor, hier zu bashen. Davon halte ich prinzipiell
überhaupt nix.

Es nur leider so, daß Personen wie No_Selters andere
Prinzipien haben und woanders ständig mit ihren provokativen
Blödel- Postings Unfrieden stiften.

Du kannst Dir das ja mal anschauen.

Es wäre sehr schön, wenn manche Leute ihre Provokationen
in anderen threads unterlassen würden. Das würde uns allen
entgegenkommen.

Ich bin dann mal weg und wünsche Dir hier alles Gute.

MfG Barca

[NoSelters]

Antwort auf Beitrag Nr.: 31.146.888 von Barcaman am 13.08.07 22:03:53

Ja hallo Jüngelchen...Willkommen!!

Das ist ja als ob ne kuh tanzen lernen wollte...

Lass bloss die finger von dndn!!...Hochspekulativ..!! Nur ne Luftnummer...!! Oh gott oh gott...

Noch viel spass bei deinem schaulaufen im lemming-ghetto...

No

[NoSelters]

Antwort auf Beitrag Nr.: 31.146.888 von Barcaman am 13.08.07 22:03:53

...Im übrigen bin ich noch stolzer besitzer von 100 ONA shares...!!!
Dann darf ich auch in den thread...

Da gibts seit langem genug sogenannte user mit N U L L ona papier aber monatlicher prämie von ... ???

So Long

No

[GuHu1]

fairer weise muss ich sagen, dass die analysten statements der wahrheit entsprechen.

"Pech gehabt" gilt für die Lemminge, die auf die Lügen von
Cyberhexe, No_Selters & Co hereingefallen sind und sich
nun die Wunden ob ihrer ihrer Verluste lecken müssen.

welche lügen sprichst du an?
ich konnte bisher keine ausmachen! das die fda nicht dem AC folgte
ist keine lüge, schön war das sicher nicht.
CH hat als mindestziel den CR letter nie ausgeschlossen, aber die wahrscheinlichkeit als gering eingestuft!
Ich meine irgendwann muss jeder seine entscheidung treffen, gehe ich mit oder steige ich aus.

der witz an der sache ist, die entscheidung über dndn`s zukunft ist bisher nur aufgeschoben und nicht aufgehoben.
ich blicke der sache optimistisch und dennoch vorsichtig ins auge.

mfg
guhu1

[Barcaman]

Antwort auf Beitrag Nr.: 31.146.548 von GuHu1 am 13.08.07 21:41:18

Hi GuHu1,

Da gibts seit langem genug sogenannte user mit N U L L
ona papier aber monatlicher prämie von ... ???

U.a. sowas meine ich, wenn ich von verlogenen usern wie
diesem No_Selters schreibe. User, die sich mit ihrem
Investment geirrt und mit Verlust verkauft haben, müssen
anschließend nicht mit Lügen und/ oder Blödelpostings
krampfhaft versuchen, miese Stimmung und Unsicherheit
zu verbreiten bzw. diese noch zu verstärken.

Diese Provokationen müssen nicht sein.

[NoSelters]

Antwort auf Beitrag Nr.: 31.147.377 von Barcaman am 13.08.07 22:43:02

...lieber blödelpostings zur erheiterung(ich kenne einige die sehr gelacht haben)...als fortdauernde wüste beleidigungen,lügen,hetze und durch pushen newbies in das papier zu treiben....Gell Barca ??!!

No

[GuHu1]

Ich will es nur event. anderen lesern verständlich machen:

MAN STREITET SICH ÜBER DAS PAPIER ONA ENERGYS

[NoSelters]

Antwort auf Beitrag Nr.: 31.147.549 von GuHu1 am 13.08.07 23:02:42

Oh Gott...Jaaa !!

C U T und E N D E !!

Go Dendreon,...go !

Naachtii..

No

[Barcaman]

Antwort auf Beitrag Nr.: 31.147.371 von GuHu1 am 13.08.07 22:42:10

Nachdem erst wieder am letzten Freitag eine, nicht die erste,
Lüge von Cyberhexe aufflog, man kann das ab Freitag nachmittag
bis Samstag abend an betsreffender Stelle nachlesen, ich habe
die Postings auch gesichert,

flüchtete die der Lüge überführte Cyberhexe endlich aus dem
Thread, zuvor versuchte sie allerdings gleichsam krampfhaft
wie vergeblich, ähnlich wie gerade der Lügner No_Selters,
mich zu diskreditieren.

Interessante Taktik. Nachdem der eigene Schwindel aufflog,
beschuldigt Cyberhexe einfach denjenigen, der das Thema Lüge
betreff's Shortseling von C.H. dezidiert aufarbeitete, also
mich, selbst zu lügen.

Miese Charaktere wie die lügenden user No_Selters und/ oder
Peler ( Doppel-ID ? ) hauen natürlich in die selbe schlechte
Kerbe.

Da ist der eine Stil, schlechter als der andere ...

Konstruktive Kritik? O.K. - Hat niemand ein Problem.

Aber Lügen? - Pfui Deibel. Was für Charaktere ...

Blödelpostings?

- Gerne, wenn's denn bitte nicht nur unterirdisches Schmuddelniveau erreicht

[GuHu1]

Antwort auf Beitrag Nr.: 31.147.702 von Barcaman am 13.08.07 23:22:55

barcaman, barcaman

CH postet hier so gut wie gar nicht mehr, wenn du eine meinungsverschiedenheit mit CH hast dann schreib ne BM.
Ich kann dir da auch nicht weiterhelfen, weil ich mich mit ONA nicht threadtechnisch beschäftige!

Ich kann also nicht sagen ob CH im ONA thread lügt oder nicht, soweit ich weiß hat CH hier nicht gelogen.

mfg
GUHU1

[GuHu1]

um für mich hier einen schlußstrich zu ziehen, empfehle ich jedem interresierten den ONA thread.
anbei ein paar auszüge vom heutigem tag:

Nicht geglückt...? Was wolltest du Blödquatscher denn sehen - 0,30...??? Ihr überbietet euch wirklich alle gegenseitig im posten von unschlagbarer gequirlter Schice...!

Sigi,
das mußt Du schon cyber-bob fragen
Er sagte doch, daß er die Schnauze voll hat.
Vielleicht brauch er aber auch "nur" dringend Kohle.

Dein notorisches vorschulhaftes Dummgebrabbel weckt in mir unbeschreibliche Aggressionen. Deiner Ausdrucksweise kann ich nur schliessen, dass du ein krankhafter Bettnässer bist.

"Zu billig...?" Hast du sie noch alle im Kasten? Was soll der Scheiss??? Du würdest wohl auch noch einen saublöd grinsenden und coolen Smilie reinsetzen, wenn der Kurs von 0,30 auf 0,31 steigen würde. Erbärmlich, diese dämliche Kurs-Schönrederei - ZUM KOTZEN...

Die grenzenlos blöde Schönrederei in allen Lebenslagen ist wie eine Seuche in diesem Thread - unerträglich, so etwas...

kann mann sich eigentlich von dem Ölfeld als Ona Aktionar selber Öl abhohlen, weil mein Auto bräuchte einen Ölwechsel. Sind ja nur 5 Liter. Wären denn die Aktionäre hier einverstanden? Vielleicht kann jemand mal Wong anrufen.

Bloss gut, dass deine grenzenlose Blödheit nicht stinkt, sonst wäre dieser Thread NOCH unerträgicher.

[Barcaman]

Antwort auf Beitrag Nr.: 31.147.748 von GuHu1 am 13.08.07 23:31:34

Ich weis zu wenig über Pharma, um hier ernsthaft eine
Mission zur "Rettung der Investierten" zu starten und
die Leute argumentativ vom Verkauf von ihren Dendreon
Aktien zu überzeugen.

Was hier passiert, werdet oder solltet ihr selbst ganz
gut wissen.

Das Cyberhexe hier im Pharmabereich sehr gut informiert
ist und nach besten Wissen und Gewissen postet und
gepostet hat, mag ich Dir und auch No_Selters gerne
glauben.

Leider gilt das nicht für andere Threads.

Schade ist, daß C.H. im Gegensatz dazu, wie auch andere
WO-User, beispielsweise No_Selters, über wenig bis keine
Kompetenz im Explorerbereich verfügen, dort jedoch
bisweilen die Rolle der großen Aufklärer und Missionare
übernehmen wollen.

Mir geht es um die Charakterzug von diesen WO-usern, die
sogar bis zum Mittel der Lüge greifen müssen, um irgendwo,
beispielsweise bei Ona Energy drauf zu hauen.

Das sind miese Charakterzüge und ihr könnt Euch kein
Bild davon machen, wenn ihr ständig Besuch von diesen
Charakteren, die nicht über explorespezifische, oder
wie C.H. letzte Freitag so offenbarte, shorttrading-
spezifische Kenntnisse verfügen, bekommt.

Warum ich Euren Therad heuite besucht habe, würde sich
vielleicht dann erklären, wenn ich von nun an in unregel-
mäßigen Abständen hier mit gut gemeinten inkompetenten
Gefasel und hin und wieder einer Lüge aufwarten würde,
um Euch zum Verkauf von Dendreon-Papieren zu raten,
und Euch zu bekehren. ( belästigen )

Das werde ich aber nicht tun.

wäre charakterlich nicht mein Ding

[GuHu1]

Ich wollte, aber ich sage nichts weiter, verweise nur auf meinen beitrag 31.147.872

gute nacht

[GuHu1]

Antwort auf Beitrag Nr.: 31.147.993 von GuHu1 am 14.08.07 00:36:08

Ich wollte, aber ich sage nichts weiter, verweise nur auf meinen beitrag 31.147.872

quatsch, zwei beiträge vorher.

[Barcaman]

Antwort auf Beitrag Nr.: 31.147.872 von GuHu1 am 14.08.07 00:00:16

anbei ein paar auszüge vom heutigem tag:



Nur zur Vervollständigung ( Du hast einen user übersehen )
verweise ich auf diese Selbstgespräche ...


#8651 von NoSelters 13.08.07 20:00:09 Beitrag Nr.: 31.145.387


W O I S T W O N G ? ? ?

No





#8652 von NoSelters 13.08.07 20:31:21 Folgende Antwort bezieht sich auf Beitrag Nr.: 31.145.387
von NoSelters am 13.08.07 20:00:09

Egal....Weiter gehts ihr ONAnisten.





No





#8653 von NoSelters 13.08.07 20:32:45 Folgende Antwort bezieht sich auf Beitrag Nr.: 31.145.742
von NoSelters am 13.08.07 20:31:21

Manchmal tuts halt weh...





No


______________________________



AUCH DAS MUSS NICHT SEIN ...

[GuHu1]

nachdem das thema hier verfehlt wurde ein netter link zu Mr. Huckman

http://www.cnbc.com/id/20265699

[GuHu1]

kleiner faktenbericht

http://donpesci.blogspot.com/2007/08/risk-averse-fda.html

[GuHu1]

cnbc Mike Huckman

http://www.cnbc.com/id/15840232?video=470205035

[NoSelters]

Antwort auf Beitrag Nr.: 31.170.918 von GuHu1 am 15.08.07 16:07:32

@ GuHu

Danke fürs Reinstellen der drei Links!!

War unterwegs und zwei Tage ohne Internet...( )

Somit extrem hilfreich. Um das komplette IV Board durchzulesen fehlt mir momentan leider die Zeit.
Gabs sonst noch was neues?

Gruss..

No

[GuHu1]

Antwort auf Beitrag Nr.: 31.187.684 von NoSelters am 16.08.07 16:49:55

nö, nur das noch von grade

aus dem IV board:

major hedge fund near collapse - Moody's Investors Services

Moody's Investors Service analysts said the credit crunch rattling global financial markets could cause the collapse of a major hedge fund, Dow Jones Newswires reported on Thursday.

As investors try to dump illiquid investments, hedge funds that are unable to exit their positions could run into trouble, resulting in the "failure and disorderly liquidation of a hedge fund of sufficient size to disrupt markets," Moody's vice chairman Chris Mahoney said during a conference call, according to Dow Jones.

http://www.cnbc.com/id/20297859/site/14081545

[surga]

Antwort auf Beitrag Nr.: 31.193.152 von GuHu1 am 16.08.07 20:59:47

sehr spannend was passiert ist zur Zeit.
DNDN verhält sich aber ziemlich stabil in Vergleich zu ELAN.
Ich hoffe, legt sich dann wieder

[GuHu1]

Antwort auf Beitrag Nr.: 31.193.854 von surga am 16.08.07 21:36:13

wie, ich hoffe legt sich dann wieder.

würde mich freuen wenn die bude mit den positiven newsflow und den "phantastischen" aussichten sich mal entsprechend verhalten würde ( kurstechnisch ).

eine annähernde news hier und die bombe platzt.
liegt möglicherweise u.a. an der hohen medienaufmerksamkeit in usa, die jungs da arbeiten echt gut.

[GuHu1]

hi hi hi, - 0,96% ist ja förmlich lächerlich verglichen zu manch anderen werten.

[GuHu1]

http://www.sciencedaily.com/releases/2007/08/070815085345.ht…

[GuHu1]

neuigkeiten aus der pipeline von dndn:

Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients

SEATTLE, August 17, 2007 - Dendreon Corporation (Nasdaq: DNDN) today announced publication of results from a Phase 1 study of NEUVENGE, an investigational active cellular immunotherapy, in the August 20 issue of the Journal of Clinical Oncology. The article highlights the safety profile, immune response and clinical activity of NEUVENGE in women with HER2/neu-positive breast cancer who have failed standard therapy.

"In addition to demonstrating that NEUVENGE was safe and well tolerated, the T-cell responses seen in these patients and the prolonged disease stabilization in the absence of other anti-cancer therapies in many patients is promising," said John W. Park, M.D., associate clinical professor of medicine and neurosurgery at the University of California, San Francisco and lead author of the publication. "These observations are encouraging and are suggestive of the clinical benefit of NEUVENGE, particularly in light of the aggressive cancer seen in these patients who had progressed while on standard therapy. The findings warrant additional studies of NEUVENGE for the many women with advanced breast cancer who have exhausted many of their treatment options."

Study Design

The Phase 1 study (D2000-2) was conducted to evaluate the safety and immunologic activity of NEUVENGE in patients with HER2-overexpressing metastatic breast cancer who had failed standard therapy, including prior treatment with chemotherapy and trastuzumab. All patients had experienced disease progression while on standard therapy. There were 19 patients enrolled in the study with 18 patients receiving treatment with NEUVENGE. Patients underwent three infusions of NEUVENGE at Weeks 0, 2, and 4 following randomization. Patients who achieved a partial response, or had stable disease lasting through Week 52, were eligible for re-treatment, a booster, using the same protocol and dose as the initial treatment. Endpoints included safety, immunologic activity and antitumor activity.

Study Results

Treatment with NEUVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion. No patient discontinued the trial because of toxicity.

Treatment with NEUVENGE stimulated significant immune responses, which were shown to be enhanced following booster infusions. Twenty-two percent of patients had evidence of anti-cancer activity. This included one patient who experienced a partial response lasting approximately 6 months and three patients who had stable disease for over a year (74.9-94.0 weeks) without the addition of any other cancer therapy other than the continuation of bisphonates. Two additional patients had stable disease for up to 20 weeks. The study concluded that NEUVENGE was feasible, well-tolerated and showed evidence of anti-cancer activity.

"We are pleased that the results from this Phase I study of NEUVENGE demonstrate its potential as a treatment for advanced breast cancer patients," said Mark Frohlich, M.D., vice president of clinical affairs at Dendreon. "These data, together with the data we have published on the use of Provenge(R) (sipuleucel-T) in prostate cancer, further substantiate the promise of active cellular immunotherapies as new treatments for different types of cancer."

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 and ovarian cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

About Breast Cancer

Breast cancer is the most common non-skin cancer among women. The chance of developing invasive breast cancer at some point in a women's life is about 1 in 8 or 13% of women. It is estimated that in 2007 about 178,480 new cases of invasive breast cancer will be diagnosed among women in the United States. Breast cancer is the second leading cause of cancer death in women, exceeded only by lung cancer.

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 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 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. Factors that could affect these forward-looking statements include, but are not limited to, the efficacy of PROVENGE or sipuleucel-T, the company's lead product candidate to treat men suffering from prostate cancer, the efficacy of NEUVENGE or lapuleucel-T, 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 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 or NEUVENGE will not support approval for a biologics license, the r
isk
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 results of a clinical trial for PROVENGE, NEUVENGE 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.

E. Blair Schoeb
WeissComm Partners
[phone]

[NoSelters]

Antwort auf Beitrag Nr.: 31.215.003 von GuHu1 am 18.08.07 13:59:01

Einen wunderschönen Guten Morgen @ all.

Das sind meiner Ansicht nach HAMMERNEWS mit weitreichenden Auswirkungen....!!
Ein weiterer Beweis daß Immuntherapie der richtige Weg ist. Und die Story wird mehr und mehr öffentlich bekannt gemacht.

Stay Ultralong.

No

[surga]

Antwort auf Beitrag Nr.: 31.224.387 von NoSelters am 20.08.07 09:15:17

Sah gut aus am Freitag

After Hours Trade Reporting

After Hours Last: $ 8.24
After Hours High: $ 9.15
After Hours Volume: 718,499
After Hours Low: $ 7.20

[surga]

Antwort auf Beitrag Nr.: 31.224.763 von surga am 20.08.07 09:47:47

Dendreon released promising Phase I data on Neuvenge

By Val Brickates Kennedy
Last Update: 8:53 AM ET Aug 20, 2007

Dendreon Corp. DNDN early Monday said it has published promising Phase I clinical data for its oncology drug Neuvenge, a proposed treatment for a type of breast cancer known as HER2/neu. The data will appear in the Aug. 20 edition of the Journal of Clinical Oncology.

...

http://www.marketwatch.com/News/Story/Story.aspx?guid=%7bCAE…

[hakur]

hi @,
gerade aus dem Urlaub zurück und Dndn beweget sich nach Norden, schönes Wiedersehen

kann mir jemand einen Link für realtime charts reinstellen , meiner funzt plötzlich nicht mehr.
Stelle ihn mal rein vielleicht kann einer von Euch diesen mal ausprobieren , könnte ja sein dass irgendwelche Einstellungen an meinem Pc flöten gegangen sind . Wäre dankbar für Rückmeldung oder auch anderen Link.
so loong

der Link den ich bisher verwendete
http://www.bigcharts.com/custom/datek-com/datek-rt2.asp?osym…

[surga]

Antwort auf Beitrag Nr.: 31.230.006 von hakur am 20.08.07 17:05:35

Hier hast Du

http://datasvr.tradearca.com/arcadataserver/JArcaBook.php?Sy…

oder

http://de.advfn.com/p.php?pid=staticchart&s=DNDN&p=0&t=23&dm…

[surga]

Antwort auf Beitrag Nr.: 31.230.701 von surga am 20.08.07 17:56:59

oder auch

http://realtime.bigcharts.com/chart.asp?type=100style=45&siz…

[hakur]

Antwort auf Beitrag Nr.: 31.230.736 von surga am 20.08.07 17:59:10

Danke Dir surga,
gibts diesen chart auch in verschiedenen Zeitintervallen also 1 min, 5 min, 15 min,..und für 1 tag , 5tage ....
habs versucht aber nicht gecheckt!
Grüße

[surga]

Antwort auf Beitrag Nr.: 31.231.055 von hakur am 20.08.07 18:26:27

Nein, leider nicht! Die waren alle realtime

Vielleicht kannst Du damit ansehen:

http://quotes.nasdaq.com/quote.dll?mode=stock&page=multi&sym…

http://quotes.nasdaq.com/quote.dll?page=charting&mode=basics…

[surga]

Antwort auf Beitrag Nr.: 31.231.055 von hakur am 20.08.07 18:26:27

Mit dieser Links kannst Du verschiedene Zeitintervalen sehen, siehe Beispiel unten 5 Tageschart:

http://quotes.nasdaq.com/quote.dll?page=charting&mode=basics…

[Bachalor]

[Poppholz]

bin auch nach ein paar Tagen wieder online und sehe mit freuden, dass der Kurs von DNDN steigt.

[NoSelters]

Dieser Thread soll ja nicht ganz "sterben"....

Mike Huckman in Action...

http://www.cnbc.com/id/20411137/site/14081545" target="_blank" rel="nofollow ugc noopener">http://www.cnbc.com/id/20411137/site/14081545


No

[NoSelters]

Antwort auf Beitrag Nr.: 31.274.109 von NoSelters am 23.08.07 21:08:02

Oder das...:


http://www.pharmalot.com/2007/08/cancer-patients-to-hold-sep…


Der Kurs ist so was von Strong die letzten Tage....
Ich bin immer mehr davon überzeugt das Dendreon SEINEN Weg macht.
Zugegeben in einem grösseren Zeitfenster als ich vermutet hatte,aber wir werden belohnt,...und zwar steuerfrei.

Spannung pur seit Monaten.

No

[GuHu1]

Hi no,
hab da auch noch was

http://www.cbsnews.com/sections/i_video/main500251.shtml?id=…

[GuHu1]

sollte auch nicht vergessen werden

http://www.CareToLive.org

[GuHu1]

Antwort auf Beitrag Nr.: 31.274.109 von NoSelters am 23.08.07 21:08:02

zwar von gestern aber hier noch nicht reingestellt.

http://investor.dendreon.com/EdgarDetail.cfm?CIK=1107332&FID…

http://www.prweb.com/releases/2007/8/prweb548604.htm

[GuHu1]

Antwort auf Beitrag Nr.: 31.286.967 von GuHu1 am 24.08.07 21:30:55

besser so

http://www.prweb.com/releases/2007/8/prweb548604.htm

[GuHu1]

Not a bummer at all, shows that they are covering. On any run up the shorts will cover and short again. Any major announcement will drive this stock back to the $9-$10 area.

ist doch klar, würde ich nicht anders machen.
erklärt auch den relativ stabilen kursverlauf der letzten 2 wochen.
wehe es kommt den shorts hier eine signifikante news ( zu provenge ) in die quere, dann ist es aus mit dem schleichenden covern.

[hakur]

Antwort auf Beitrag Nr.: 31.288.161 von GuHu1 am 24.08.07 22:41:29

hi guhu,
meiner bescheidenen Meinung nach ist hier jemand sehr gedultig am einsammeln.
Wenn ich mich recht erinnere hat Gold bei seinem letzten öffentlichen Interview, bei welchem er kaum Neuigkeiten herauslies, allen zum Abschluß noch einen schönen Urlaubs-Sommer gewünscht.Dieser so teilte mir mein Neffe welcher in S.Diego lebt mit endet in den States Anfang September. Mir war so als ob er den Analysten mit einem Augenzwinker sagen wollte wartet mal ab, so long, bis dahin.Lets see.
Der Chart würde vom Timing her gesehen eine mögliche News um diesem Zeitpunkt +/- hergeben .
Wie immer ohne Gewähr
so loong

[GuHu1]

Antwort auf Beitrag Nr.: 31.290.203 von hakur am 25.08.07 12:24:45

Hi hakur

schön das du wieder an board bist, wie war dein urlaub?

Mir war so als ob er den Analysten mit einem Augenzwinker sagen wollte wartet mal ab, so long, bis dahin.Lets see.

ich bin zurück, du bist zurück, würde sagen wir sind bereit mr. gold.

das schöne daran ist, wir müssen die von CH eingestellten studienergebnisse nicht ausseinander klabüsern. hier wurde u.a. durch CH sehr gut gearbeitet und die fakten liegen auf dem tisch.

goldstandart ist OS ( overall survival siehe auch gpc ) dieser sollte in den zwischenergebnissen der laufenden studie nachgewiesen bzw. untermauert werden.
das ist der schlüssel und jeder schritt in die richtung wird den kurs des papiers erheblich nach norden bringen.

nicht zu vergessen die hohe medienaufmerksamkeit in usa!

DHSZ

[Poppholz]

DNDN steht in den USA schön im Plus.

Aktuell: $8,10

[Bachalor]

[GuHu1]

http://www.thetimes-tribune.com/site/index.cfm?newsid=187252…

[GuHu1]

Technical Analysis

Dendreon Corp. (DNDN) - Intermediate term bullish symmetrical continuation triangle.

http://newsletter.secinvestor.com/2007/08/27/Newsletter+For+…

ob da was dran ist?

[hakur]

Antwort auf Beitrag Nr.: 31.310.219 von GuHu1 am 27.08.07 23:54:40

Bekomme das nie gebacken.
Kann mal jemand den chart von tradin_n_mowin Msg: 152735
aus dem IV board hier rüber kleben.
Noselters vielleicht , Du hattest so meine ich mir schonmal erklärt, bin zu ...
Danke
so loong

[NoSelters]

Antwort auf Beitrag Nr.: 31.321.524 von hakur am 28.08.07 20:33:24

Gruss

No

[NoSelters]

So isses recht...

http://hf-implode.com/

No

[NoSelters]

Nachgereicht noch die Einschätzung von "hanslebo" :


TA - update
This chart is complements of Hanslebo, our esteemed colleague from Germany.

He confirms that the downward pitchfork has been successfully breached last week, and the uptrend since last March is intact.

The RSI and OBV oscillators confirm the upward power.

Hanslebo's proprietary symmetry analysis gives some probability of DNDN trading over $9 soon.

Good luck to all!

tradin'

[brokerrene]

DENDREON - Warten auf neue TrendsignaleDatum 01.08.2007 - Uhrzeit 15:16 (© BörseGo GmbH 2007, Autor: Rain André, Charttechniker, © GodmodeTrader - http://www.godmode-trader.de/)
WKN: 615606 | ISIN: US24823Q1076 | Intradaykurs:

Dendreon - Kürzel: DNDN - ISIN: US24823Q1076

Börse: NYSE in USD / Kursstand: 7,61 $

Kursverlauf vom 30.06.2002 bis 31.07.2007 (log. Kerzenchartdarstellung / 1 Kerze = 1 Woche)

Rückblick: Die DENDREON Aktie brach nach dreijähriger, moderater Abwärtskorrektur im März 2007 über den mittelfristigen Abwärtstrend aus und vollzog einen gewaltigen Kurssprung bis fast an das AllTimeHigh bei 26,63 $. Im Widerstandsbereich bei 24,75 - 26,63 $ markierte die Aktie im April ein Hoch und brach anschließend deutlisch ein. Seit Mai beruhigt sich der extrem volatile Kursverlauf nun, die Aktie pendelt sich im Bereich der EMAs (EMA50, EMA200 bei 6,87 - 7,20 $) ein. Das kurz- und mittelfristige Chartbild ist neutral zu werten.

Charttechnischer Ausblick: Die nachrichtenbedingten Kurskapriolen der vergangenen Monate haben die Anleger deutlich verunsichert, die kurzfristige Devise lautet nun: Warten auf neue Trendsignale. Ein Anstieg per Tages- und Wochenschluss über 8,35 $ könnte eine neue Aufwärtsbewegung bis 13,00 - 14,92 und darüber 24,75 - 26,63 $ initiieren. Fällt die Aktie hingegen per Tages- und Wochenschluss unter 6,30 $ zurück, drohen weitere Kursverluste bis 3,68 $.

[surga]

[GuHu1]

Antwort auf Beitrag Nr.: 31.323.937 von brokerrene am 29.08.07 01:08:55

yep, kennt man ja, vergessen wird da immer der druck der auf dem kessel ist.

[GuHu1]

na dann

PROSTATE CANCER
IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) </dndn/prostate>
Dendreon is no longer recruiting patients for the IMPACT Trial.
If you would like to contacted about future trials, contact 1-866-4PROSTATE
(1-866-477-6782) or periodically refer back to this website.

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

[GuHu1]

die andere seite der macht

Crou that's not really true at all, so don't get your hopes up. We "stupid Hedgies," short big caps as well, and go long on small caps too. However, with an undecided economy, playing the options on positions is where you maintain the balance. There are some very complicated models used to predict this. As far as Dendreon moving into double digits in the near future, won't happen. The only event that would facilitate a spike is a partnership, with a strong well- established pharma. Even then, it would be only temporary. Dendreon has to produce a product. That simple. Oh yea, and get rid of Gold.

[NoSelters]

Antwort auf Beitrag Nr.: 31.378.968 von GuHu1 am 03.09.07 23:45:35

#4366 von GuHu1 03.09.07 23:45:35 Beitrag Nr.: 31.378.968
Dieses Posting: versenden | melden | drucken | Antwort schreiben | DENDREON CORP.



Folgende Antwort bezieht sich auf Beitrag Nr.: 31.323.937 von brokerrene am 29.08.07 01:08:55
--------------------------------------------------------------------------------
yep, kennt man ja, vergessen wird da immer der druck der auf dem kessel ist.

Wie recht Du hattest...!




No

[surga]

sehr starker Umsatz heute

[GuHu1]

bin echt etwas überrascht, ich hatte mich ein wenig zurückgenommen, surftechnisch.
weiss einer ob es etwas handfestes gibt oder ob \"nur\" gecovert wurde?

werd jetzt auch mal etwas mehr schauen.

DHSZ

@ no
mit dem kesselspruch habe ich jetzt schon ne doppelphrase kreiert

[GuHu1]

Dockets Entered On September 6, 2007

Docket # Title

1978N-0038 Sunscreen Drug Products

1998D-0307 Exports/Imports under FDA export reform/enhancement Act 1996

1998D-1232 Points to Consider Guidance Documents on Assayed & Unassayed Quality Control Material

1998N-0359 Program priorities/Center for Food Safety & Applied Nutrition

1999D-1651 Chemistry,Mfging/Control Changes to an approved NADA/ANADA

2004D-0002 Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants

2004N-0234 Annual Guidance Agenda

2004V-0537 Projector for a Laser Light Show

2006D-0451 Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers

2006N-0292 Unique Device Identification

2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

2006P-0071 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation

2006P-0394 Revise the labeling requirements for eggs sold in the United States

2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

2007D-0212 Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis

2007D-0233 Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

2007N-0218 Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products (Formally Medical Device Adverse Event Reporting Program)


2007N-0264 Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule

2007N-0329 Determination That Miltown (meprobamate) Tablets and 5 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

2007P-0097 Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa



2007P-0275 To permit an ANDA Suitability for Nabumetone Tablets 1000 mg

2007P-0282 Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%

2007P-0297 Request to reconsider the failure to approve Provenge

Wenn ich mich recht erinnere stand das doch schon ein mal auf der tagesordnung!?

Bin jetzt nicht sicher ob da was dran ist, also mit vorsicht genießen!

[NoSelters]

BNP Paribas reports an 8.81% Passive stake in Dendreon-DNDN

aus IV

No

[NoSelters]

Antwort auf Beitrag Nr.: 31.511.404 von NoSelters am 10.09.07 21:27:57

BNP Paribas ist eine der führenden Geschäftsbanken Frankreichs und Europas. Sie entstand am 23. Mai 2000 durch die Fusion der Banque Nationale de Paris (BNP) und der Paribas. Zusammen mit der Société Générale und dem Crédit Lyonnais gehört sie zu den drei alten Geschäftsbanken („les trois vieilles“) Frankreichs.

[GuHu1]

@no
warte mal noch, ist noch nicht ganz klar was da läuft.

[NoSelters]

Antwort auf Beitrag Nr.: 31.511.807 von GuHu1 am 10.09.07 21:41:48

................................Good News........................
Most important news since approvable letter. Now there is a BIG bank in the picture that will put PRESSURE on Gold & BOD to create meaningful traction & progress.

Such outside PRESSURE is long overdue. BNP will look to maximize their investment. Surely BNP has good relations with Sanofi & other large bioPharmas. Now Gold will feel more on the hot seat. The endless treadmill running will end. Shorts will need to sweat. Very bullish afternoon for dndn & longs.

Von binder IV

Seh ich genauso.

No

[GuHu1]

DNDN:US
Dendreon Corp
Dendreon Shares Gain on `Chatter' About Delayed Drug's Status

By Robert Greene

Sept. 10 (Bloomberg) -- Dendreon Corp., the developer of a prostate-cancer drug delayed by U.S. regulators, gained the most in almost two months on the Nasdaq Stock Market on ``chatter'' about the treatment's status.

The price rose 39 cents, or 5.1 percent, to $8.09 a share at 2:04 p.m. New York time in composite trading and earlier climbed 10 percent. Dendreon hasn't jumped that much in a day since gaining 10 percent on June 27.

Dendreon rose on talk among stock traders that the prostate- cancer drug Provenge received fast-track status from regulators, meaning they will examine research data as they become available. That status was granted in November 2005 for Provenge, the company's lead product. The Food and Drug Administration this year told Dendreon, of Seattle, that it will need to perform additional studies before the drug can be considered for approval.

``It's fast-track chatter,'' said Mike Capitani, head of equity trading at Caris & Co. in New York. ``The story's been around for a while that their prostate cancer drug is going to get fast-tracked.''

To contact the reporter on this story: Robert Greene in Washington at [e-mail] .

Last Updated: September 10, 2007 14:10 EDT

[GuHu1]

@kakur
wie beurteilst du das.

[GuHu1]

@ no
wer war zuerst da, das huhn oder das ei?
bin mir nicht sicher ob der heutige kursverlauf nur auf BNP zurückzuführen ist.
kann aber durchaus auch so sein.

ich finde die folgende ansicht nett, wobei
das nur spekulation gepaart mit wunschdenken ist, oder.

Just food for thought......; Gold bought some shares not too long ago; then he and CFO were in Europe in August....; the rally on the September the 18th; then today some French hedge fund scoping some cheap shares on a Monday....I don't know about you but the rest of this week or early next week I expect some fireworks. Screw the shorts!!!

unter dem strich bleibt stehen:
da ist und bleibt ne menge druck auf dem kessel!!!!

[hakur]

Antwort auf Beitrag Nr.: 31.513.310 von GuHu1 am 10.09.07 22:24:50

hi guhu,
was soll ich dazu sagen, beziehe mich im wesentlichen auf den Chart.natürlich schau ich auch auf die Story ect pp .
Mein Verstand sagt mir , wenn eine Bank in dieser Größenordnung von 8.8% in eine Firma einsteigt wird das schon seine Gründe haben. Banken wollen Geld verdienen, ;-)

Wiederhole einfach nochmal meinen Letzten Beitrag von Ende August, war schon am Zweifeln ob das hinhaut mit dieser Aussage einer Prognose für Anfang Sept. !

Zitat:
hi guhu,
meiner bescheidenen Meinung nach ist hier jemand sehr gedultig am einsammeln.
Wenn ich mich recht erinnere hat Gold bei seinem letzten öffentlichen Interview, bei welchem er kaum Neuigkeiten herauslies, allen zum Abschluß noch einen schönen Urlaubs-Sommer gewünscht.Dieser so teilte mir mein Neffe welcher in S.Diego lebt mit endet in den States Anfang September. Mir war so als ob er den Analysten mit einem Augenzwinker sagen wollte wartet mal ab, so long, bis dahin.Lets see.
Der Chart würde vom Timing her gesehen eine mögliche News um diesem Zeitpunkt +/- hergeben .
Wie immer ohne Gewähr
so loong

sag mal vorsichtig , die positive Tendenz des Charts hält noch.
Werde in den nächsten Tagen wenns zeitlich passt einen neuen reinstellen.
so loong

[GuHu1]

September 11, 2007

Institutional Buyer Sheds Light on Dendreon (DNDN)

An interesting event happened yesterday in the form of an SEC Filing on Dendreon (NASDAQNDN) that ran the stock. In a fed-filing from yesterday it was disclosed that BNP Paribas Arbitrage SA held 6,961,101 shares of Dendreon stock. That equates to an 8.18% stake. If you review the June 30, 2007 holders, this will put BNP Paribas at roughly double the holdings held by Barclays (largest holder previously).

This filing actually lists the transaction date as JULY 25, 2007, so there is a full six weeks of look back here. If that form is accurate on the ownership date, shares are higher now than on the trade date. Also last night the company filed its form 424B3, which allows holders of the 4.75% convertible senior subordinated notes that were placed on June 11 and July 11, 2007 to resell notes and common shares. This is actually a common event and does not necessarily mean any such sale is pending.

Other than its breast cancer Phase I data from last month, this one has been fairly quiet on the news front of late.

Yesterday there were some 13.68 million shares that traded hands and shares rose 5.6% from Friday's close. Shares are up another 1.5% today at $8.25 and it has already traded over 6 million shares in less than two hours of being open. The stock did briefly put in a near-term high of $8.48 today, but have come back in. The $8.30 to $8.35 had been the prior intra-day levels that acted as intraday highs in both July and August.

Jon C. Ogg
September 11, 2007

http://www.247wallst.com/2007/09/institutional-b.html

[NoSelters]

Antwort auf Beitrag Nr.: 31.515.287 von hakur am 10.09.07 23:34:33

Werde in den nächsten Tagen wenns zeitlich passt einen neuen reinstellen.

Hi hakur,

bin schon mächtig gespannt!

Machs einfach passend.

Danke vorab.

No

[surga]

http://www.pharmalot.com/2007/09/cancer-patients-ask-court-f…

Cancer Patients Ask Court For Provenge
September 11th, 2007 10:42 am By Ed Silverman

provenge.jpgThis isn’t surprising. Having already filed a lawsuit against the FDA for failing to approve the prostate-cancer vaccine, an anonymous group of cancer patients (and perhaps some investors) are now asking a federal court in Ohio to grant an emergency injunction that would make Dendreon’s Provenge available immediately to cancer sufferers. The move comes just before a planned Sept. 18 rally at FDA offices in Maryland.

The 55-page motion, which was filed by the recently formed non-profit, CareToLive, recaps the events surrounding the controversial FDA advisory panel meeting last spring in which Provenge was recommended for approval. Although at times the filing is sarcastic and rambling, the motion is interesting reading because it lays out a conspiracy theory that an FDA official, Richard Pazdur, allegedly orchestrated the subsequent approval delay conflicts of interest and improperly leaked info about the matter to a newsletter.

Meanwhile, sources familiar with this mess say the FDA is conducting an internal probe into the alleged conflicts, although an agency spokeswoman declined to comment, citing the litigation. The allegations center on Howard Scher, a prominent physician at the Memorial Sloan-Kettering Cancer Center in New York, who is also an advisory board member to a venture capital fund that invested in at least one company developing a rival prostate-cancer med. As reported previously, this info wasn’t disclosed on his waiver forms prior to the panel meeting.

“The FDA has failed to act, continues to refuse to act, and it is clearly aware that it should have acted, in the best interest of the patient population it is sworn to protect,” the motion states. “Each and every day the FDA fails to abide by its own rules and regulations, and continues to ignore the purpose and intent of the Congressional mandate set out for them, including protecting the health and well being of the citizens of the United States…more than 80 men die without hope.”

[NoSelters]

This chart has been provided by Hanslebo, our esteemed colleague from Germany.

Hanslebo uses a proprietary technical system he calls kinetics, along with conventional TA concepts.

The current zone of compression (the trading days since May 9) indicate a high probability of a large price change. The time-frame also has a high probability of being imminent.


Good luck to all DNDN investors !!


No

[Poppholz]

ein Ausbruch aus den beiden Kreisen nach oben wäre schon eine schöne Sache.

[GuHu1]

lesenswertes aus dem IV board:


Thoughts on recent posts and discussion with Greg Schiffman 9/13/07

On every MB for every stock, you will inevitably find posters who are down on the management. It doesn't matter what industry, it doesn't matter whether the stock is up or down (although one finds these malcontents most often with stocks whose price has fallen or whose price hasn't gone up much over a period of time), there just seem to be dissatisfaction with the CEO, CFO, and/or IR. Check it out for yourself. I follow a number of stocks and am always looking for new ones to invest in, and sure enough there are the posters with a grievance.

DNDN is saddled with its detractors. Most love the science but can't stand Dr. Gold, Monique (who has now left the company, sadly for me), and there have been others. I haven't posted much since May 9 as there really hasn't been much to discuss. I have felt that management had done what they could to get Provenge approved and are now doing what they can, as fast as they can, to go for the approval again. After the positive Panel, it has been clear to me as it has been to many others, the fault for Provenge not getting approved could be laid to the CDER/ODAC side of the FDA. Possibly there was some complicity at CBER and possibly on a higher level, but the letters of Scher, Hussain, and Flemming were clear where the initial problem lay.

Now some think that DNDN did a poor job at the Panel meeting, but the results were overwhelmingly positive, so the DNDN people who presented there along with the BLA details, were good enough. Yes, it needed a phrase revision re the efficacy, but that was resolved.

Maybe someone else posting on the MB could have done better over the years or after the FDA decision, but I doubt it. I have been an avid reader of the posts over the last @3 years on Yahoo, IV and IHub. There have been some terrific posts by some really knowledgible people. But I don't think I have seen anyone's posts who could have done as good a job as the DNDN management breaking new ground re the immunotherapy field with a revolutionary new concept, adapting to changes in the way patients responded, and working with the FDA to provide a compatible BLA that should have been approved, set up a viable 157,000 sq. ft. facility in about one year for the production of Provenge, get the antigen supply approved and on stream with Diosynth, get sufficient funding (albeit with a rather ineffective approach- this now seems to have improved with the new CFO), get the BLA sent to the FDA with the first computerized submission of any company, get the CMC and BLA reviewed with priority, and then the positive Panel along with presentations at conferences and publications, and so many other things.

Frankly, anyone long this stock over the last 3 years should be looking at management as doing a very good job versus the lousy and perfidious job done by the FDA. I have great admiration for KDD, AMMASS, Yarbonero/ Mr. Serious, cben, walldiver, rancherho, ocyan, clarkster, and all of the many people who have spent incredible hours to refute the Scher, Hussain, Pazdur, Cancer Letter, analysts, and others initially after the May 9 decision and now with the demonstrations and the lawsuit against the FDA, et.al.

I have given how I feel about this and there are many, I'm sure, who will disagree with me. Such is life.

Now I am going to tell you of my discussion with DNDN's CFO Greg Schiffman (GS) on Thurs., Sept 13, 2007.

I met with GS briefly, along with some others, at the ASM. I knew he wouldn't remember me by name, but he remembered that I had used the word "Pazdurized" to reflect my disgust of the one man I felt had done so much to hurt a new field of cancer research as well as subvert an FDA approval for a drug which would helped many men with PC. He did remember that part.

Below are my impressions and understandings of my discussion with GS. As I was hurriedly writing down notes of our discussion, it is hoped that my notes are accurate. I have tried to put the discussion in a way that is more readible. Please understand that GS was very detailed in his answers and I have tried to capture the key points and substance of his answers. I hope I have not misrepresented his points in any way.

Ques: Why hasn't DNDN set up operations in a foreign country that has easier entry to providing Provenge to patients? For example, one that would recognize that the safety/efficacy re 9901/9902a and the Panel recommendation should have been sufficient for FDA approval. A smaller, NJ type plant could be established, possibly through an already established, approved facility. Presumably there would be leukopharesis facilities available in the area or easily set up. Countries that I suggested were: Dubai (as per Casey), Israel, Norway. and Thailand. There shouldn't be any problem with the FDA as companies are doing this all of the time.

Ans: DNDN had priorities. First, we had to find out what the FDA wanted from us re the BLA and then the trial data. This had to be determined and this has been done. Secondly, the plan of action had to be commensurate with our finances. Now that we have resolved these issues, we are able to look at other possibilities.

It is important to understand that many countries determine whether they will approve certain drugs based on U.S. and European approval. There are a number who do not but there may be certain qualifications to be considered. DNDN is evaluating a wide range of options and there is nothing specific at this time. But DNDN has been active in this area.

Ques: When should we hear news on 9902B full enrollment?

Ans: At this time, DNDN is no longer accepting applications for pre-enrollment. Enrollment is before the first infusion is given (either placebo or shot).

DNDN will announce when there is full enrollment. Guidance is for the 4th quarter of 2007.

Ques: How many employees are there at this time and I noticed that there are some new job openings?

Ans: There are about 200 employees and the new hires are based on specific needs of the company.

Ques: Will there be an announcment when the NJ plant 483 issues are resolved with the FDA? Any time frame? How could they be doing Provenge for 9902b if there was an FDA issue?

Before I go into the ans. on this, I want to say I have tried to understand and write the subtleties of GS's answer as best as I can. There are some on this MB that are far more knowledgible about this subject than I am and it might be helpful for these people to contact DNDN to confirm or amplify my notes on this.


Ans: When the NJ plant was inspected re the CMC, the FDA issued some feedback, ie., 483s. The 483s are not the same as the CMC. The person who oversaw the inspections was the one who was available to discuss the CMC and the 483 issues prior to (or during?) the Panel meeting. The CMC was available at the time of the Panel (AC). There were no issues that arose to a point which was "rate limiting" (AND THIS IS THE IMPORTANT POINT) and there was nothing material in the 483s that would have affected getting product approval. The CMC and the 483 issues were done at different times, both were part of the "approvable" letter. Apparently there needed to be some further discussion with the FDA on these issues at the time (as per my understanding).

Follow-on question: How could the NJ plant produce Provenge for the 9902B trial if there was a problem with the FDA with regard to the facilities or re the CMC?

Ans: There was nothing re the 483s to restrict doing Provenge for the 9902B trial. However, the plant could not produce Provenge for commercial quantities.

Follow-on question: When will the 483 issues be resolved, ie., when will there be a "pre-approved re-inspection"?

Ans: The FDA itself will give no formal documentation until the application is updated. There will be another inspection and the results will be part of the re-submission of the amended BLA filing.

Ques: Is Dr. Small still working with DNDN and in what capacity? Who is the lead researcher re 9902B?

Ans: Dr. Small's center is one of many re 9902B. He was the lead researcher on 9901. He is not the principal researcher on 9902B. He could not say who was. The main point is that Dr. Small is still associated with Provenge (which is what Monique told me at the ASM and which I reported on the MB a while ago).

Ques: What about finding a partner for Neuvenge which has several possible cancers that could be addressed?

Ans: Most potential partners are looking for advanced Phase trial results. Their first choice would be Provenge. He had no specific comments at this time whether there was any interest in Neuvenge re partnerships or with Provenge. They have had a number of prospects which they are evaluating was my understanding.

Ques: Could he comment on the efforts made re the law suit or the demonstrations?

Ans: GS could only answer regarding advocacy groups in general. He could understand their frustration. He and DNDN could not comment in any way. However, given the time frame of the mid 2nd half of 2008 when the interim look should occur, he wasn't sure whether they could speed up any time re FDA consideration or not. Basically, DNDN can't comment on such matters and I am sure everyone should be able to understand why they cannot.

Conclusions:

I found GS to be open, informative, and really helpful in my seeing the difficulties management has been faced with the "approvable" decision by the FDA. I believe that they have not been issuing a lot of press releases as their efforts have been directed toward getting the 9902B trial enrolled, getting the financing, resolving FDA issues, evaluating partnership and foreign opportunities, and moving forward as quickly as possible to make DNDN a viable player in the cancer arena.

For myself, I have been in and out of DNDN since May 9 on a trading basis. I am currently about 2/3rds the position I had before 5/9. Barring bad news or a technical aberration to the downside, I am looking to build my position. While I do not hold out much hope that the FDA will see the light and give a conditional approval to Provenge, I am hoping for DNDN to look outside the U.S. for additional opportunities.

[hakur]

nur ganz kurz.
einige Leute im IV sehen einen Zusammenhang zwischen dem Kursanstieg am letzeten Montag ca. 11°°US Zeit und der eingereichten Klage von Kerry Donahue
Dhttp://www.caretolive.com/CareToLiveinjunction.pdf

Auf der letzten Seite 55 dieses PDf könnt Ihr sehen , dass diese Klage um 10°° eingereicht wurde. Es wird gesagt dass die großen Hedge Funds dies auch mitbekommen haben
Soweit ein Beitrag zum steigenden Druck im Kessel.

Das E-mail Zitat hierzu :
So all the hedge funds knew about this PDF last Monday morning (Sept 10),

Übrigens gibts von tradin_n_mowin noch eine chartanalyse , diesmal von a_technical_1 erstellt , No kannst Du es vielleicht hier ins Board kleben? Thanks!
mal schaun was die Zeit bringt


Habe eben noch diese Nachricht tradin_n_mowin bekommen,setze Sie in Kopie rein. -ohne Kommentar-
Yes, I think the lawsuit will have more effect in the very near future.Go to post 155582. It has dates. It would be interesting if any of these dates appear on your charts.

Have a great day!
So loong, einen schönen Sonntag

[NoSelters]

Antwort auf Beitrag Nr.: 31.603.368 von hakur am 16.09.07 12:52:10

Übrigens gibts von tradin_n_mowin noch eine chartanalyse , diesmal von a_technical_1 erstellt , No kannst Du es vielleicht hier ins Board kleben? Thanks!

Du meinst doch sicherlich den Chart, 3 Postings über Deinem...?



No

[hakur]

Antwort auf Beitrag Nr.: 31.628.358 von NoSelters am 17.09.07 10:01:13

ich meine Posting Nr. 155766
so loong

[NoSelters]

Antwort auf Beitrag Nr.: 31.628.608 von hakur am 17.09.07 10:29:10

TA - update from a_tech


Here we have an TA update from a_technical_1, our longtime friend, esteemed colleague and TA afficionado.
a_tech uses a slightly different approach from Hanslebo, in message 155569, but the conclusion is the same.
a_tech sees the ascending triangle being very likely resolved to the upside. A close above the 6 month resistance level of $8.30 (the red line) is very bullish. A close above the 150 day moving average (the blue line) will likely trigger some panic short covering, easily propelling the stock into double digits..

[franz991]

Antwort auf Beitrag Nr.: 31.628.794 von NoSelters am 17.09.07 10:48:27

Denk mal "die haben bald fertig..."

[NoSelters]

Langsam kommt Bewegung rein....(Bloomberg Artikel)

http://www.bloomberg.com/apps/news?pid=20601087&sid=a4X6Hpme…

No

[GuHu1]

Antwort auf Beitrag Nr.: 31.629.875 von franz991 am 17.09.07 12:36:29

von wem redest du?

[GuHu1]

eindrücke zur demo vom 18.09, ob es hilft?

Brief Summary of Rally Part One

I will post a better update later as time allows, but let me say this:

Chief did an outstanding job getting this rally all organized and making it such a success. I believe there were just north of 100 folks (counts varied from about 100-130) there, all very vocal and wonderful. Heartfelt support was felt and shared by all. Speakers were tremendous. Frank Burroughs, Bruce Towers (a true tear-jerker, no doubt), Matt Alsante, Ray Matyshyn, Steven Walker (a late add but a very powerful speech), Charlie Reinwald, Mike Kearney, Kerry D. (who did an amazing job once the speakers stopped working completely, he just took over with his great voice and really brought some emotional energy up in the crowd!), and I ended the planned speeches. A couple of folks took advantage of open mike after that, including FPDOC, who shared very impressively as well and is really turning into a fantastic congressional advocate in his own right.

Several good media folks there. cameras from CNBC, reporters from Forbes, Seattle Times, Reuters, and a couple of advocacy group writers as well. Thurly took some great video as well which I hope to see in a few days after he\'s had a chance to recover a bit.

Thanks to everyone involved for an amazing and heartfelt effort. Our voices were loud, in unison, and together we demanded change at the FDA NOW!

Provenge NOW!
Genasense NOW!
Junovan NOW!

Fire Pazdur NOW! (That was a fun one!)

Best to all.

Scott

[GuHu1]

reuters:

http://www.reuters.com/article/governmentFilingsNews/idUSN17…

[LaPlue]

Dendreon Announces Webcast Presentation at UBS Life Sciences Conference

SEATTLE, September 18, 2007 - Dendreon Corporation (Nasdaq: DNDN) today
announced that management will participate in the UBS Global Life Sciences
Conference.

UBS Global Life Sciences Conference
Grand Hyatt New York
Thursday, September 27, 2007
9:00 a.m. ET

The presentation will be audio webcast live and available for replay from
Dendreon's website, www.dendreon.com.

Dendreon 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.

Contact:
Greg Schiffman
Chief Financial Officer
Dendreon Corporation
[phone]

Jennifer Cook Williams
Investor Relations
Dendreon Corporation
[phone]

[GuHu1]

seattle times:

http://seattletimes.nwsource.com/html/businesstechnology/200…

[GuHu1]

nicht gerade positiv der folgende bericht.
aber wir wollen doch ausgewogen bleiben, oder.

http://www.biotechblitz.com/2007/09/cancer_immunotherapy_is_…

[GuHu1]

hab lange überlegt ob ichs reinstellen soll.
um nicht zu nerven werd ich mich jetzt wieder zurücknehmen.


http://www.oncologystat.com/home/news/Tempest_Over_Cancer_Dr…



Tempest Over Cancer Drug Leaves Threatening Legacy
Elsevier Global Medical News. 2007 Sept 17, B. Bates

Controversy is a fact of life for pharmaceutical companies and the Food and Drug Administration, but the ongoing saga of an investigative immunotherapeutic agent for advanced prostate cancer has been unusually contentious.

The struggle to gain FDA approval for sipuleucel-T, to be marketed as Provenge by Dendreon Corp., has been marked by a raucous FDA meeting, picketing in Washington, congressional lobbying, a federal lawsuit, conspiracy theories, conflict of interest allegations, death threats against scientists, investor fury, scientists' indignation, and the employment of bodyguards at a major cancer meeting.

A final decision about whether to approve the drug now awaits interim findings from a 500-patient phase III trial, but in the meantime, the Provenge controversy has ignited activism among prostate cancer patients, their families, and investors that is reminiscent of the highly charged battles to get HIV drugs "fast tracked" in the 1980s.

The dispute has raised questions about whether biologic agents can be judged by the same efficacy standards as traditional drugs, particularly when the goal is to treat terminal patients who have few alternatives.

It has generated concern by some scientists about the increasing influence of "antiscience" voices in American life, from the highest reaches of government to physician-patient bedside deliberations.

Finally, it has highlighted media pressure on the scientific community to justify established principles guiding medical policy decisions in the face of tearful families and angry investor campaigns organized at lightning speed over the Internet.

The controversy began March 29, when officials of the Seattle-based biotech firm presented to the FDA's Cellular, Tissue, and Gene Therapies Advisory Committeethe results of two fast-tracked, phase III parallel studies of their biologic agent in a total of 225 men with asymptomatic, hormone-refractory, metastatic prostate cancer.

Sipuleucel-T would be the first oncologic drug in a new class, designed to stimulate a patient's immune system with a customized "vaccine" made from his own peripheral blood mononuclear cells, including antigen-presenting cells. Extracted by plasmapheresis, the cells are flown to a centralized laboratory where they are activated with a recombinant fusion protein containing prostate antigen fused to GM-CSF, an immune cell activator. Within 3 days after collection, the stimulated cells are reinfused into the patient in an outpatient procedure.

Following the March FDA committee meeting (see box), at least two committee members, Dr. Howard I. Scher, an oncologist at Memorial Sloan-Kettering Cancer Center in New York, and Dr. Maha Hussain, professor of internal medicine and urology at the University of Michigan, Ann Arbor, sent letters to the FDA to express their concern about the implications of approving the drug based on the evidence.

The letters were leaked and widely reprinted, first in The Cancer Letter and then online.

Dr. Scher's letter stated that inconsistent trial data "do not constitute 'proof' of benefit or justify a conclusion that they are 'reasonably likely' to predict benefit. …C onsequently, the only conclusion that can be reached is that the survival difference observed may have occurred by chance alone."

The company had argued that the survival results were "clinically meaningful, significantly persuasive, and internally consistent in the intent-to-treat population," a position that Greg Schiffman, chief financial officer for Dendreon, reiterated in a telephone interview.

Years ago, when the small phase III trials were designed, using time to progression as a surrogate for survival was "pretty typical," Mr. Schiffman said. Research has since shown that survival is a better benchmark, and it is the primary end point in Dendreon's larger phase III trial, he explained.

At the FDA committee meeting, Dr. Mark Frohlich, vice president of clinical affairs for Dendreon, said that survival is the "least biased, least variable, and most clinically meaningful" end point, and on that measure, sipuleucel-T succeeded, the company maintained.

A 4.5-month survival benefit from a drug with few side effects is urgently needed by prostate cancer patients, who now gain only about a 2-month survival advantage from docetaxel (Taxotere), a drug with side effects that many patients find debilitating, advocates and company experts emphasized.

On May 9, a day dubbed "Black Wednesday" in an opinion piece in the Wall Street Journal, the FDA rejected the committee recommendation to approve sipuleucel-T and requested more data from Dendreon.

The decision sparked a debate in the oncology community and beyond about whether the FDA's restraint represented a scientifically valid concern about the efficacy of a treatment that failed to pass muster in clinical trials, or a risk-averse philosophy depriving desperate patients of treatments that offer them their only hope of prolonged survival.

Within the month, Dr. David Penson of the University of Southern California, Los Angeles, presided over a press briefing at the annual meeting of the American Urological Association marked by frustration about the FDA decision.

Dr. Penson listed three reasons the FDA might reject an advisory committee's recommendation to approve a drug: safety, efficacy, and politics.

"No one's arguing safety. It was 17-0," he said.

"Efficacy? The panel voted 13-4. Maybe it wasn't a slam dunk, but it wasn't close, either," he said.

He paused.

"Politics I can't comment on," he said.

"Urologists and medical oncologists were really hoping this would be approved, just because these patients have so few other options. We're still left with this terrible problem, a man who has advanced prostate cancer, and a chemo regimen which, while it does extend quantity of life, it doesn't help quality of life," Dr. Penson said.

Dr. Penson's own review of the data would have convinced him to approve the drug, he said. "Here's a treatment that probably works, is clearly safe, and doesn't detract from quality of life.

"These patients are desperate. They are very excited that a drug may extend their lives 3-4 months with minimal side effects," he added.

Dr. Mark Thornton, writing in the Wall Street Journal on May 14, accused committee members of "kneeling before the altar of statistics" in failing to recommend approval of Provenge or another investigational drug, Junovan, an immunotherapeutic treatment for osteosarcoma.

"In the span of 8 hours, the dawn of a new era in cancer immunotherapy was driven back into the night," said Dr. Thornton, former medical officer for the FDA's Office of Oncology Products, senior vice president for the biopharmaceutical corporation GenVec, and an advisor to the advocacy group Abigail Alliance for Better Access to Developmental Drugs.

Quickly, other established advocacy groups such as the Prostate Cancer Research Institute became involved in the quest for approval.

"Provenge was a little bit different for us," PCRI spokesperson Jan Manarite said in a telephone interview.

"It was a different type of drug, and the public outcry was huge. Overwhelming," she said.

Questions of efficacy and cost that arose during the FDA panel meeting and afterward "are all important concerns, but concerns that should never be more important than the individual," she added.

Ms. Manarite, whose husband is a long-time survivor of prostate cancer, said the controversy over Provenge and other experimental drugs may help build a "meaningful dialogue" between the FDA and advocacy groups about efficacy criteria and accelerated approval standards.

Outside the small circle of established patient advocacy groups, however, the dialogue soon turned vitriolic, especially within the anonymous confines of Internet chat rooms and blogs.

A Dendreon investor's much-visited MySpace page began playing Mozart's Requiem I while displaying a cartoon of a grinning Grim Reaper carrying a scythe labeled "FDA." An image of a mature antigen-presenting cell stands next to toppled cemetery crosses.

Web sites erupted with accusations of conflict of interest aimed at committee members who had questioned whether the data justified approval of Provenge. Their photographs, and those of FDA administrators, were accompanied by inflammatory statements about their motives and character.

The New York Times reported on June 3 that serious threats had been made against Dr. Scher and Dr. Hussain. Bodyguards appeared at the annual meeting of the American Society of Clinical Oncology (ASCO) in early June in Chicago, where both oncologists were due to speak.

Nor was the press immune.

Coverage of the controversy by The Cancer Letter, a weekly publication about academic, industry, and research news, generated an e-mail to editor Paul Goldberg expressing the wish that he and all male members of his staff be diagnosed with prostate cancer.

"This is not the level of discourse you would hope people would be using in the discussion of whether a drug should be approved," he said in a telephone interview.

"The Web has a disinhibiting effect on some people, who seem to feel comfortable saying things under the guise of anonymity that they wouldn't say if their names were attached," he added.

An FDA spokeswoman said in late August that the agency can no longer comment on the Provenge issue, following the July 30 filing of a federal lawsuit by Care to Live, an Ohio nonprofit organization seeking an emergency injunction that would make the drug available to cancer patients.

(A U.S. Court of Appeals, District of Columbia Circuit, in early August ruled that patients do not have a constitutional right to unapproved drugs, in a suit brought by the Abigail Alliance for Better Access to Developmental Drugs. The Alliance has vowed to appeal.)

Meanwhile, Dendreon announced that the FDA had decided to accept either a positive interim or final analysis of survival from its ongoing, phase III, 500-patient IMPACT study as the basis for amending the Biologics License Application that was filed on a fast-track basis in early 2007, possibly paving the way for drug approval as soon as 2008.

In the meantime, the Provenge controversy seems to have unleashed a dialogue over far more than the future of one immunologic agent for the treatment of prostate cancer.

Dr. Len Lichtenfeld confessed in his blog on the American Cancer Society Web site that he had temporarily censored his own comments on the issue out of fear of retribution.

In his blog column, "When Fear Intimidates Science," he admitted he revised a draft of his column after learning of "threats of the most serious kind" against scientists scheduled to speak at ASCO.

Dr. Lichtenfeld wrote that he welcomes public discussion on the topic of access to investigational drugs. "But to threaten established, knowledgeable investigators who honestly express their well-reasoned opinions, which in turn 'chills' rational discussion is, from my point of view, simply unacceptable," he said.

In an editorial in the journal he edits, Nature Clinical Practice Oncology, former National Cancer Institute director Dr. Vincent T. DeVita Jr., decried the cheering and booing that reportedly marked the FDA advisory committee meeting on Provenge as "patient advocacy at its worst.

"It is easy to understand how patients and their advocates can be seduced by the age old lure of a harmless drug stimulating the immune system," Dr. DeVita wrote. But it would set a "dangerous precedent" to approve a vaccine that is short on positive efficacy data (and, he maintains, less promising than other advanced prostate cancer drugs in the pipeline), even if it is "fairly nontoxic," he said.

If the FDA had approved Provenge after the contentious meeting, the agency would have "[assumed] the role of oncologist of last resort" and be forced to acknowledge it as a new standard of care, against which all new therapies would have to compete head-to-head for approval, he said.

The situation would slow, not accelerate, the development of new drugs," Dr. DeVita wrote.

Meanwhile, Dendreon officials hope that their ongoing study will establish the scientific merit of sipuleucel-T.

Patient accrual for the IMPACT trial is nearly complete, with interim survival data expected in mid- to late 2008, Mr. Schiffman said in a telephone interview.

"We do understand the frustration that exists," he said. "Are we frustrated? Yes. But we are also working as best we can to move forward within the regulatory pathway."

The company, Mr. Schiffman added, "does not, and never has condoned … extreme behavior."

In the meantime, Forbes.com reported in July that the Securities and Exchange Commission has launched an "informal inquiry" into Dendreonin the context of "multiple insider sales," including the sale of 202,000 shares by its chief executive officer during volatile trading in which the stock rose to over $20 a share before it plummeted, following the FDA decision, to below $5 a share.

Because it is merely a review and not an investigation, the SEC may never announce its findings if it concludes that no wrongdoing occurred, Mr. Schiffman said.

[NoSelters]

Antwort auf Beitrag Nr.: 31.666.947 von GuHu1 am 19.09.07 20:38:45

Eine perfekte Kurzfassung der Dendreon-Saga.


No

[NoSelters]

Bevorstehender Ausbruch..??



TA update - Hanslebo
Here we have an interday update from Hanslebo.

The trading range of the stock continues to be be bound up by the converging buying and selling forces.

We appear to be at the very end of the wedge/triangle.
Thanks to Hanslebo for the chart and the fine detail!!


No

[GuHu1]

http://www.twst.com/blog/?p=44

Liisa Bayko, an analyst at Next Generation Equity Research, is worried about her sell rating on Dendreon. Here's the info:

In our coverage of biotechnology this week, analyst Liisa Bayko talks about her concerns in the Biotechnology Sector:

TWST: Are there any names that worry you?

Ms. Bayko: I think Dendreon is a little bit of a worry because it’s so volatile.It’s trading up now, and I have a sell rating on it. They are in the prostate cancer space. Their ongoing trial is called IMPACT, and we are going to have the data from that the middle of the next year. I worry if that’s going to be positive. They are putting so much into making that positive, that’s my concern. If it’s not positive, then what?

[NoSelters]

Daily Death Count : Today = 11,454
Good morning everybody. Today is Black Wednesday plus 138.

Since the FDA issued the Approvable Letter and delayed patient access to Provenge, 11,454 men have now suffered needlessly premature and painful deaths from prostate cancer as a result of the lack of availability of Provenge.

Meantime, many more men continue to be unnecessarily at risk for a premature and painful death due to the lack of approval and availability of this life-saving therapy. And the advance of immunotherapy technology generally continue to be stymied.

When will the hypocrisy end ??



No

[GuHu1]

bin mal gespannt ob donnerstag 15:00 MEZ etwas positives zu vermelden ist?
der druck wird immer stärker.

ein weiteres beispiel für das hohe öffentliche interesse in usa.

http://www.lef.org/magazine/mag2007/sep2007_awsi_02.htm

[NoSelters]

M.Huckman...

http://www.cnbc.com/id/21014428

No

[NoSelters]

Antwort auf Beitrag Nr.: 31.768.609 von NoSelters am 27.09.07 20:34:39

Go.....

No

[GuHu1]

weiterhin geduldig bleiben heißt die deviese.

As far as the controversy over the drug and the FDA's handling of it, Dr. Gold would only say,

"Our goal is to fundamentally change the way that cancer is treated. Clearly there's been, umm, a lot of hope and I think discussion on whether these types of therapies (therapeutic cancer vaccines) are gonna have a role in the treatment of cancer. And we believe very strongly that they do. And the reason that we believe that is because the data supports a significant survival benefit in a patient population with a large unmet medical need. The physicians are very interested in getting these types of products available to them…."

[GuHu1]

ich kann das folgende nicht beurteilen, handelt sich um eine einschätzung aus dem IV board.
also bitte mit der entsprechenden vorsicht genießen.

Positive reflections from a lurker.
In 9901, roughly 50% of Provenge and placebo patients also got taxotere. Provenge then Taxotere = 34.5 month median survival after 36 months. The placebo/taxotere patients lived about 25 months. The takeaway is that provenge/taxotere is way better than provenge or taxotere alone.

Here's the differences. For 9902B, many more patients will have taken taxotere since taxotere is now FDA approved for AIPC, which it wasn't during most of the 9901 trial period. This is good for Provenge if you believe the post hoc statistical studies done by Dr. Petrylak concerning Provenge/taxotere synergy.

Here's another nice thing. In 9901 if you lived more than 36 months you only counted as if you lived for 36 months in the statistical comparison to placebo. In 9902B, if you live 36+ months those extra months are included in the statistical comparison.

Sanofi-aventis knows this stuff. Logic and good business sense would lead them to want to partner up with DNDN. I think this is in the works. The Paribas investment may or may not be connected to this. But why else would they acquire 8+% of a company with no revenue?

Sanofi has to be looking at it this way, "We will sell a lot more taxotere if AIPC patients can expect to see an extra year or more median survival instead of the measly 2.5 months with taxotere alone."

This doesn't make 9902B interim a slam dunk. But I think the interim look will answer all the questions the FDA has concerning the efficacy of Provenge. What will the FDA do if the median survival for provenge is 34.5+ months versus ~25 for placebo but has a borderline p-value? If the p-value is even close the FDA and especially WS will see it as positive.

I expect the timeline for the interim look, assuming 180 death events, is more likely late 2008 to early 2009 due to the synergic effects of provenge/taxotere. This will likely lead to more Gold bashing next summer as we anticipate the release date that doesn't happen. But if the stats from 9901 carry over to 9902B, we may have to wait longer for the results but we may have a lot of happy grandfathers participating in next years FDA protest.

[GuHu1]

na dann laßt den worten auch taten folgen


SEATTLE, October 1 /Bogus YIRNP/ -- Dendreon Corporation (Nasdaq: DNDN - News: None) today announced the Company is displeased to announce that today it's the thousandth consecutive day Dendreon stock is listed in the Regulation SHO Threshold List published on the NASDAQ Trader website.

"We clearly don't like our Company and our shareholders are being screwed by dishonest market makers" says Mr. Gregory T. Schiffman MBA, CPA, Chief Financial Officer, Sr. VP and Treasurer; "We'll fight until death and beyond to put a stop to this malpractice. We really think times are due for a change and we will have our revenge thanks to the marketing approval of Provenge (R)". Mr. Gregory T. Schiffman continues "We are working days and nights to have Provenge (R) on the market. Any market will do".

We were able to record only two words Dr. Mitchell H. Gold M.D., Chief Executive Officer, President, uttered: "No comment".

[GuHu1]

obs hilft?

http://www.lawyersandsettlements.com/articles/01430/fda-laws…

[hakur]

lange gabs charttechnisch keinen Grund etwas zu posten.
Jetzt hat sich seit 11 September ein flacher fallender Keil ausgebildet, mal sehen wie er sich auflöst. Hoffen wir nach Norden :-)

so loong
immer noch

[URL]http://www.tradesignalonline.com/content.asp?p=wpa/tsb/default.asp&fcid=2359957[/URL]
[URLChart öffnen]http://www.tradesignalonline.com/content.asp?p=wpa/tsb/default.asp&fcid=2359957[/URL]

[hakur]

Antwort auf Beitrag Nr.: 31.846.418 von hakur am 04.10.07 19:24:42

setze den Chart mit dem fallenden Keil nochmal größer rein da kaum zu erkennen im vorherigen
so loong
[URL]http://www.tradesignalonline.com/content.asp?p=wpa/tsb/default.asp&fcid=2360384[/URL]
[URLChart öffnen]http://www.tradesignalonline.com/content.asp?p=wpa/tsb/default.asp&fcid=2360384[/URL]

[Ville7]

DNDN ist Top geshorteter Biotech-Stock im NBI:

http://www.minyanville.com/articles/Fed-FOMC-Genentech-Dendr…

[GuHu1]

Antwort auf Beitrag Nr.: 31.863.808 von Ville7 am 06.10.07 07:22:13

klar, war der wert doch schon immer.
um so heftiger wirken sich event. positive news aus, wenn sie denn kommen.

[edelupolino]

Antwort auf Beitrag Nr.: 31.846.418 von hakur am 04.10.07 19:24:42

wär wirklich schön...

übrigens: tolle charts von dir wie immer...

[uk0804]

Antwort auf Beitrag Nr.: 31.894.119 von edelupolino am 07.10.07 22:36:28

OpEdNews

Original Content at http://www.opednews.com/articles/genera_evelyn_p_071009_fda_…


--------------------------------------------------------------------------------
October 9, 2007

FDA Industry Insiders Derail Approval of New Cancer Treatments

By none

FDA Industry Insiders Derail Approval of New Cancer Treatments

George W Bush's FDA, stacked with insiders from the industry that literally carried him to Washington, has stooped to a new low to protect the obscene profits of the multi-billion dollar cancer industry by blocking the approval of a new class of immunotherapies that can extend the lives of dying cancer patients with minimal side effects.

In the May 14, 2007, Wall Street Journal, a former medical officer in the FDA Office of Oncology Products, Dr Mark Thornton, denounced the FDA's decisions, and stated, "May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday."

"Within an eight-hour period that day," he wrote, "the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient's immune system against cancer."

Experts say, the new immunotherapies hold promise for many forms of cancer. "FDA's hubris will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers," according to Dr Thornton.

With the approval of the new therapies, the profits, along with the horrendous side effects of the only treatments now available, could become a thing of the past. "One day current treatment approaches such as surgery, radiation and chemotherapy, which often kill most but not all of a cancer, could be made obsolete by a potent immune response that eradicates the cancer cells and provides subsequent protection against return and relapse," Dr Thornton wrote.

As such, the new therapies pose a grave threat to the cancer industry as a whole, and the lost profits would not be limited to the sale of products. The pharmaceutical giants have spent a small fortune to gain control of every segment of the industry, from researchers to government regulators, and every year, billions of dollars flow through a nationwide network of research institutions and treatment providers under the guise of finding a cure for cancer.

However, the profits up for grabs have become so enormous that critics say the goal of industry-controlled research is no longer focused on finding a cure for cancer to save lives. Instead, the focus is on thwarting the development and approval of new therapies in order to protect the profits of the treatments already on the market.

The FDA's refusal to approve Provenge, a new immunotherapy vaccine manufactured by the Dendreon Corporation, has caused major outrage in the cancer community. Provenge supporters have sent thousands upon thousands of letters and other correspondence to the FDA, members of Congress, the Department of Justice and others.

In addition, the Ohio-based non-profit corporation, CareToLive, has filed a lawsuit on behalf of terminal cancer patients seeking a declaratory judgment that the FDA acted "arbitrarily" and "capriciously" by denying patients access to Provenge, in violation of their constitutional right to live.

Dendreon sought approval to treat late-stage androgen-independent prostate cancer (AIPC) patients who have no other options. A study presented to an FDA Advisory Committee at a March 29, 2007, meeting showed that, after 36 months, 34% of the men who received Provenge in a clinical trial were still alive, compared to only 11% of those who received a placebo.

Provenge is designed to stimulate the patient's own immune system to specifically attack only cancer cells, unlike chemo drugs that attack any fast-growing line of cells.
Patients who qualify for Provenge have already had their prostates removed or have undergone radiation and hormone therapy. Eligible patients receive a one-time round of treatment consisting of 3 visits to a urologist's or oncologist's office to give blood, and 3 visits for the blood enhanced with Provenge to be infused back into the body.

On September 10, 2007, CareToLive filed a motion asking the court to issue an order enjoining the FDA from denying the marketing and distribution of Provenge. The plaintiffs charge that within six months, another 15,000 patients will have died waiting for justice.

The memorandum filed with the motion points out that the only available treatment approved for terminal AIPC in the last 42 years is a chemo drug, Taxotere. "The effectiveness of Taxotere," it states, "is so superficial, and the side effects so severe, that most men decline the treatment, as the risks far outweigh the benefits."

According to the filing, between 300 and 600 patients per year die from the Taxotere treatment itself. "This is truly amazing," the memo states, "considering the cost of the treatment and the cost of hospitalization and that the average benefit is an increase in survival of only 2 ½ months."

In contrast, the Provenge safety profile is so good that nobody has died from it and less than one in four patients experience side effects consisting of mild flu-like symptoms lasting one or two days, the memo notes.

The defendants named in the lawsuit include Mike Leavitt, Secretary of the US Department of Health and Human Services; FDA Commissioner Andrew von Eschenbach; Dr Richard Pazdur, head of the FDA's Office of Oncologic Drug Division, and Dr Howard Scher, chosen by Dr Pazdur to serve on the advisory panel set up to review the approval of Provenge.

CareToLive is represented pro bono by Attorney Kerry Donahue, of the Dublin, Ohio law firm Bellinger & Donahue, while the FDA officials are represented by a legal team of 11 government attorneys, at last count, funded by tax dollars.

The plaintiffs allege that the defendants engaged in a conspiracy to prevent the approval of Provenge and that Dr Pazdur, "purposely located two conflicted oncologists who he was sure for a variety of reasons would be anti-Provenge and he instructed them to try to derail the approval of Provenge."

The plaintiffs charge that, by choosing Dr Scher, and also Dr Maha Hussain, to serve on the advisory panel, Dr Pazdur "likely found two of the most conflicted oncologists in the country to sit in judgment of Provenge, and who would both assuredly continue his plot to lobby others at the FDA to vote for non-approval."

At the behest of Dr Pazdur, and for their own future political and monetary gain, the plaintiffs claim, "these two oncologists did everything they could think of to obstruct and impede the approval of Provenge."

The waiver of conflicts of interest granted by the FDA to Dr Hussain, which allowed her sit on the panel, reveals that she is the lead investigator on a research contract awarded by a company that competes with Dendreon, and her husband owns stock in three competing companies valued at between $15,000 and $300,000.

The lawsuit alleges that, as part of the conspiracy, on May 9, 2007, the FDA denied terminally-ill patients access to Provenge, even though the FDA Advisory Committee recommended approval, found the vaccine safe by a 17-0 vote and found there was "substantial evidence" of efficacy with Provenge by a 13-4 vote.

In an attempt to derail an approval recommendation by the panel, the plaintiffs claim that, prior to the vote on efficacy, Dr Pazdur and "his co-conspirators changed the statutory question regarding efficacy from 'substantial evidence' to 'absolute certainty' of efficacy, in an effort to obtain a 'no' vote on Provenge."

However, during the voting, this manipulation was discovered and promptly corrected by the FDA's Dr Celia Witten and Dr Jesse Goodman, and by an overwhelming majority, the panel voted "yes" to the revised efficacy question.

"It is unprecedented for the FDA to overturn the Advisory Committee on such a positive vote when men are out of options, delaying approval and asking for more trials," according to CareToLive spokesman Mike Kearny in an August 2, 2007, press release.

"Men are dying now," he states. "They do not have years to wait."

In the case of Provenge's approval, the profits at stake could not be higher. Prostate cancer is the most common non-skin cancer in the US and the third most common cancer worldwide. More than one million men in the US have prostate cancer, with an estimated 232,000 new cases diagnosed each year and more than 30,000 men face death from the disease each year.

As an initial treatment, when diagnosed with prostate cancer, most men have their prostate removed, or undergo radiation, which can lead to various degrees of incontinence and impotence. After the initial treatments fails, hormone therapy is given to block the production of androgens such as testosterone, needed for cancer cells to grow, and some men undergo testicle removal in an attempt to stop the androgens from spreading the cancer.

With AIPC patients, prostate cancer has usually gone into remission and then returned, spreading to other parts of the body including the bones, lymph nodes, bladder, rectum, liver and lungs. All men who do not die of other causes progress to the final stage where the cells no longer respond to hormone therapy. Provenge is intended for use by patients who have already failed other types of therapy.

Because Taxotere is the only approved drug, Sanofi would have suffered the greatest immediate loss had Provenge been approved. According to firm's 2006 Annual Report, Taxotere was the company's 4th best-selling product in 2006, and the US is listed as the number one country contributing to sales.

As far as profits per dose, in the February 7, 2007, article, "What Does It Cost to Have Cancer?", a patient who received the chemo drug for breast cancer in 2006 reported that "each infusion of Taxotere cost over $16,000."

She also stated: "That's just for the drug, not administration or anything."

According to the lawsuit, defendant Dr Scher, Chief Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, is a scientific advisor and lead trial investigator for a competitor of Dendreon called Novacea. Under faculty disclosures at the University of Michigan, Dr Hussain is listed as an advisory board member of Novacea, and she receives research funding from Sanofi.

Dr Scher also has an interest in ProQuest Investments, which stood to reap windfall profits if Provenge was not approved. ProQuest is a venture capital fund established in 1998, in large part by Michael Milken, who was given the nickname "Junk Bond King," after being indicted on nearly 100 counts of insider trading and sentenced to 10 years in prison, in addition to being barred from the securities industry for life.

The ProQuest fund was established with a specific focus on prostate cancer, and SEC filings show that ProQuest and its principals are major shareholders of Novacea.

Citing documents from ProQuest, the plaintiffs allege that Dr Scher is a "ProQuest Executive" and "member of the Board of Directors", ProQuest reaps millions of dollars investing in prostate cancer companies based on advice from doctors such as Dr Scher, and ProQuest own stock in direct competitors including Novacea.

Dr Scher receives compensation from ProQuest as a scientific advisor recommending investments and for conducting clinical trials that result from the investments. He also holds an ownership interest in ProQuest.

The lawsuit also alleges that Dr Scher receives research support from the Prostate Cancer Foundation, as well as financial benefits, as one of a consortium of members who reviews new research on cancer drugs to determine which grants should be awarded by the Foundation.

The PCF, also founded by Mr Milken, is one of the largest sources of funding for the National Cancer Institute and government research programs. A following of the tangled web involved in the PCF reveals that Dr Jonathan Simons, President of the Foundation, Dr Stuart Holden, Medical Director, and Dr Howard Soule, an Executive Vice President of the Foundation, are all scientific advisors to ProQuest.

Another research arm found to be infested with several of the same insiders is the Prostrate Cancer Research Program, within the Department of Defense, which since 1997 has been appropriated a total of $730 million by Congress. According to a PCRP report, "Today, the PCRP is the second leading source of extramural prostate cancer research funding in the United States."

The PCRP funds a Clinical Consortium Award to support the creation of a major multi-institutional clinical trial resource, "to speed development of novel therapeutics that will ultimately decrease the impact of the disease."

Here, too, Dr Scher is listed as the leader of the consortium, and the list of participating clinical sites and lead investigators includes none other than Dr Hussain. Dr Simons is listed as developing new clinical therapeutics for late-stage prostate cancer, but a review of upcoming research listed in the report shows immunotherapies are not in the cards.

These consortium members are invaluable to the industry and investors due to their unique access to insider information about clinical trials and influence over the FDA approval process. Evidence of this claim came on May 30, 2007, less than 3 weeks after approval for Provenge was denied, when Novacea announced an agreement with Schering-Plough worth over $450 million, in which Schering agreed to jointly fund and develop Asentar, a competing prostate cancer drug, for which Dr Scher happens to be the lead investigator.

"The partnership leverages Novacea's existing capabilities with Schering-Plough's experienced development, regulatory and commercial teams and will provide Novacea with an opportunity to support the commercialization of Asentar in the United States," John Walker, company chairman and interim CEO, stated in a May 30, 2007 press release.

A May 2000 ProQuest document provides insight about the investment firm's interest in Asentar's success and states: "ProQuest Investments is a $100 million oncology-focused investment fund, partnered by Jeremy Goldberg and Jay Moorin."

Mr Moorin owned 1,910,988 shares of Novacea stock at the time of a May 15, 2006, SEC filing, and the ProQuest document mentions an investment from Domain Associates, "whose general partner, Jim Blair, has also worked with the fund to plot its strategy."

As it turns out, Mr Blair and Mr Moorin were both members of Novacea's board of directors when the Schering deal was set up. However, apparently their services are no longer needed, because on August 30, 2007, Novacea announced the resignation of James Blair and Jay Moorin, effective September 4, 2007, and September 19, 2007, respectively.

All that said, it does not take a financial genius to figure out that this whole deal could have gone up in smoke had Provenge been approved, because there would have been a drastic drop in the enrollment of late-stage cancer patients in clinical trials as soon as they learned that there was a new vaccine that could not only increase their survival rate but allow them to live out their final days without the agonizing side effects of chemotherapy.

Provenge's approval also would have caused many patients currently participating in trials to drop out. Novacea's 2006 Annual Report filed on April 2, 2007, less than 2 months before the Shering announcement, warned that the "clinical development and regulatory approval processes inherently contain significant risks and uncertainties."

The report shows Novacea was going broke trying to keep the Asentar trials running, with research and development expenses associated with the drug of $12.9 million for the year ended December 31, 2006, up from $7.3 million for the year ended December 31, 2005.

The $5.6 million increase was due primarily to the Phase 3 Asentar trial, and the filing warns that Novacea could experience many delays in getting its product to market due to problems in trials including, "patient enrollment may be slower than expected at trial sites due to factors including the limited number of, and substantial competition for, suitable patients with the particular types of cancer required for enrollment in our clinical trials".

It also notes that there "is a limited number of, and substantial competition for, suitable sites to conduct our clinical trials; clinical trial sites may terminate our clinical trials"; "patients and medical investigators may be unwilling or unable to follow our clinical trial protocols;" and "patients may fail to complete our clinical trials once enrolled."

In addition, another ongoing trial is evaluating Asentar as part of a combination therapy for AIPC patients with Sanofi's Taxotere. If safety or efficacy issues arise with Taxotere, the annual report warns, Novacea could experience significant regulatory delays, and the clinical trial may need to be terminated or redesigned.

Even if Asentar were to receive FDA approval, Novacea would continue to be subject to the risks that could arise with Taxotere or that Taxotere may be replaced as the standard of care for AIPC. "This could result in Asentar ™ being removed from the market or being less commercially successful," the report states.

Ironically, in one of 3 derogatory letters sent to the FDA urging the non-approval of Provenge leaked to the media following the failed efforts to rig the advisory panel vote, Dr Scher discussed the same fatal effects that the approval could have on the research industry. "An approval recommendation has far reaching implications beyond making the product available that the data simply do not support or justify," he wrote.

Approval would provide the Agency's endorsement of Provenge as a "standard of care" for men with AICP, he said, and by extension, elevate Provenge "to a position of being the new 'control' arm for future randomized phase 3 trials that are being designed for the regulatory approval of any new experimental agent or approach."

In other words, all the billions of dollars invested in the clinical trials now underway, or set to begin, conducted in hopes of gaining FDA approval for a new ACIP treatment, could go right down the drain if Provenge is approved as the first-line treatment for this patient population.

Dr Scher is probably more aware of this fact than anybody. On February 26, 2007, MedPage Today reported that in a satellite symposium titled, "Improving Upon Current Standards: The Integration of Novel Therapies in the Treatment of Androgen-Independent Prostate Cancer," sponsored by Novacea, Dr Scher said Taxotere-based combination therapy is being investigated in a dozen clinical trials for ACIP patients, and he reported receiving grants and research support from both Novacea and Sanofi.



Authors Bio: Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

[surga]

wird mal langsam Zeit

[GuHu1]

geht heut ja mal nett hoch, was sagt der weitere chart hakur.

http://washingtontimes.com/apps/pbcs.dll/article?AID=/200710…

[NoSelters]

Spekulationen auf eine Übernahme durch Sanofi-Aventis im IV-Board.


Würde Sinn machen für SA,allein schon wegen der Kombi mit Taxotere.

Aber wollen wir das wirklich?...vor einer Zulassung von Provenge?
Wie nah ist DNDN tatsächlich dran an einem conditional approval..??

Es bleibt spannend.


No

P.S. Freu mich schon auf Hakurs Chartanalyse

[Cashverbrenner]

Spekulationen auf eine Übernahme durch Sanofi-Aventis im IV-Board

Das ist kompletter Quatsch. SA hat null Interesse an Dendreon.
SA will bei therapeutischen Krebs-Antikörpern zukaufen.

[GuHu1]

Antwort auf Beitrag Nr.: 31.930.967 von Cashverbrenner am 10.10.07 20:28:08

um so besser, bin eh der meinung dndn sollte den weg jetzt soweit es geht alleine gehen.
sollte es dann doch zur zulassung reichen, drücke mich hier absichtlich etwas vorsichtig aus, raucht es im karton.

@ cashverbrenner
wie es laufen kann haben wir schließlich alle teils mit weinendem, teils mit lachendem auge gesehen (GPC + DNDN ). bei mir überwiegt das lachende (finanziell betrachtet) ein weinendes habe ich bzgl. der vergebenden change für die patienten.

[GuHu1]

600k shares in the last 10 minutes. Whole lotta fun

nah, wer wars, raus mit der sprache.

[Bachalor]

[GuHu1]

Antwort auf Beitrag Nr.: 31.932.739 von Bachalor am 10.10.07 22:24:16

als hätt ichs gewußt, bacha wars.

[Bachalor]

Antwort auf Beitrag Nr.: 31.932.852 von GuHu1 am 10.10.07 22:33:07

wer gmfx hat als aktie brauch keine nerven




http://www.myvideo.de/watch/132190



N8

[euroturk]

12.10.2007 13:00
Dendreon Secures $130 Million Committed Equity Financing Facility

SEATTLE, Oct. 12 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nachrichten) today announced that it has obtained a committed equity financing facility under which it may sell up to $130 million of its registered common stock to Azimuth Opportunity, Ltd. over an 18-month period. Dendreon is not obligated to utilize any of the $130 million facility and remains free to enter into and consummate other equity and debt financing transactions.

Dendreon will determine, at its sole discretion, the timing, dollar amount and floor price per share of each draw under this facility, subject to certain conditions. The number and price of shares sold in each draw are determined by a contractual formula, whereby Dendreon will issue shares to Azimuth when and if Dendreon elects to use the facility at a small discount to the volume weighted average price of Dendreon's common stock over a preceding period of trading days. Reedland Capital Partners will act as placement agent and receive a fee for its services at the time of any draw under the facility. Any shares sold under this facility will be sold pursuant to a shelf registration statement declared effective by the Securities and Exchange Commission on May 25, 2007.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any state.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, market demand for Dendreon's common stock and events and developments affecting Dendreon's business and prospects. 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/.

Quelle: finanznachrichten.de

[euroturk]

Dendreon Secures Equity Facility
Friday October 12, 8:11 am ET
Dendreon Secures Equity Financing Facility Allowing It to Sell $130M in Stock

SEATTLE (AP) -- Biotechnology company Dendreon Corp. said Friday it agreed to a new financing facility that will allow it to sell up to $130 million of its common stock to investment firm Azimuth Opportunity Ltd.

Under the terms of the facility, Dendreon can sell the stock over an 18-month period.

Dendreon said it is not obligated to use any of the facility and may make other financing arrangements.
Quelle:http://biz.yahoo.com/ap/071012/dendreon_equity_financing_fac…

[Bachalor]

[xero1972]

DENDREON CP (U-DNDN) - News Release
Dendreon Completes Target Enrollment of 500 Patients in Phase 3 IMPACT Study of Provenge(R) For Advanced Prostate Cancer

2007-10-23 07:00 ET - News Release



SEATTLE, Oct. 23 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced that the Company has completed enrollment of over 500 patients in the Phase 3 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. The IMPACT study is a double-blind, randomized, placebo-controlled Phase 3 trial designed to measure overall survival in men with metastatic hormone-refractory prostate cancer receiving PROVENGE versus placebo.

Earlier this year, following a positive recommendation from an outside panel of experts, Dendreon received a complete response letter from the U.S. Food and Drug Administration (FDA) that asked for additional evidence that would support the efficacy of PROVENGE. Subsequently, Dendreon received confirmation that the FDA will accept either a positive interim or positive final analysis of overall survival from the IMPACT study to amend the Biologics License Application (BLA) and support the efficacy claim for PROVENGE.

"The completion of enrollment of over 500 patients into the IMPACT study is a major achievement for the organization, as the data from this trial may provide the FDA with the additional clinical data they need for the approval of PROVENGE," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Men with late stage prostate cancer currently have few appealing treatment options available to them. We believe PROVENGE has the potential to offer both oncologists and urologists a well tolerated treatment option for their patients that has the ability to extend survival."

The IMPACT study enrolled more than 500 patients at 70 centers in the United States and Canada. Patients with metastatic androgen-independent prostate cancer were eligible for the study. The primary endpoint of the study is overall survival (an event-driven analysis), and time to objective disease progression is a secondary endpoint. The company currently expects an interim analysis for overall survival to be performed in the second half of 2008.

"This study provides the medical community an important opportunity to better define the efficacy and safety profile of PROVENGE in men with metastatic androgen-independent prostate cancer," said Philip Kantoff, M.D., a principal investigator of IMPACT and chief clinical research officer and chief of the Division of Solid Tumor Oncology at the Dana-Farber Cancer Institute. "Considering the limited treatment options available to these critically ill patients, there is a real need for new, safe and effective treatments, particularly those providing a survival benefit."

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 218,890 new cases expected to be diagnosed in 2007, and more than 27,000 men expected to die this year from the disease. Currently, there are limited treatment options for men with advanced, metastatic prostate cancer.

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 re-engage the patient's own immune system with the goal of turning it "back on" to elicit a specific long-lasting response against cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

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 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 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.

Dendreon Corporation



CONTACT: Investors, Jennifer Cook Williams of Dendreon Corporation,
[phone]; Media, Katherine Stueland of WeissComm Partners,
[phone]



Web site: http://www.dendreon.com/

[GuHu1]

Antwort auf Beitrag Nr.: 32.119.424 von xero1972 am 23.10.07 13:19:21

Full enrollment wurde ja erwartet, ist also keine news mit richtiger durchschlagskraft, aber immerhin.

mitch wurde vorher auch wieder aktiv.

http://www.shareholder.com/Common/Edgar/1107332/1209191-07-5…

[GuHu1]

http://www.cnbc.com/id/21437720?__source=RSS*blog*&par=RSS

Dendreon's Provenge Trial: Big Step On Bumpy Road
Posted By:Mike Huckman

It isn't moving the stock, but Dendreon Dendreon Corp DNDN
this morning announced that it has signed up all of the patients for the big clinical trial that could lead to its prostate cancer drug, Provenge, winning Food and Drug Administration approval.

The completion of enrollment was not unexpected, so that's why people aren't trading on the news. Nonetheless, it's another step forward on the long, bumpy road for Provenge.

And another excuse for me to blog about this company which, as I've mentioned before, drives traffic. I've even heard through the grapevine that a certain web-based biotech reporter has been told by her/his editors to try to work the name "Dendreon" into as many articles as possible simply because it results in such a huge spike in page views.

So, DNDN has more than 500 patients participating in the clinical trial which is taking place at more than 70 sites in North America. It's not a surprise that it was able to quickly get people to sign up for the test since advanced prostate cancer patients have little else left to try and the buzz in the prostate cancer community is that Provenge holds great promise. But the men enroll knowing that they could get the real thing or a placebo.

Each patient will get three big blood draws over the course of a month or so and then the blood is mixed with the Provenge/placebo and reinfused back into their bodies. The company says the interim analysis of the data will be done in the second half of next year. If they show in those sneak-peek results that Provenge appears to extend patients' lives that could lead to FDA approval.

However, in a research note to clients this morning, Rodman & Renshaw biotech analyst Ren Benjamin writes, "…we continue to believe that the likelihood of achieving a statistically significant result at interim is low…." Benjamin cites three reasons for his opinion:

1. Therapeutic cancer vaccines may take longer than conventional chemo to show a positive effect.
2. Interim data have what he calls a high statistical hurdle to clear.
3. And it's just too tough to handicap interim results. R&R makes a market in DNDN.

[GuHu1]

chancen/risiko analyse aus dem IV board.

"Anyone who gives a probability is guessing"

That is definitely true. However, we can make some assumptions and come up with reasonable expectations.
If 9902b tracks 9901 both in the make up of the patient population as well as in its relation to the covariates (cox analysis), then we can be rather sure that the 9902b interim will meet whatever stringent p value requirement it has to accomplish assuming that requirement is of the order of 0.0...
If 9902b instead tracks 9902a, then all bets are off as far as guessing on the probability of an interim success...
Chances of the interim 9902b resulting in a p value less than 0.05 are however extremely high unless the Provenge effect is really a fallacy of our imagination, which I highly doubt. I believe that DNDN will file in that case on the bases of 9902b being supportive of 9901, and I believe the probability of approval in that case is high if the patient advocacy groups keep the pressure on the FDA through that time frame...
In the unlikely event that 9902b results in a survival p-value higher than 0.05, I think the stock will sell off really hard (sub $2 comes to mind) and will not recover until maybe the final results are released by 2010. Although 2010 is not that far away, a failure of 9902b interim to demonstrate even a 0.05 cox survival p value would make many of us suspicious of the Provenge effect...
So, to put all of that into a guesstimate as far as the pps is concerned, this is how I would break it down for the pps at the end of 2008:

30% chance of beating the stringent interim p value: stock flies past $60 on that news...

60% chance of the p value being below the usual statistical threshold of 0.05 but higher than the interim requirement: stock will gain substantially and pass $20 but will hesitate to fly until an FDA decision is made in 2009...

10% chance of neither of the above and the stock will probably head below $2 for a while...

All in all, an excellent risk/reward ratio going forward but, unless you are actively trading, you have to have the patience to hold your position for a year or so...

[GuHu1]

http://www.shareholder.com/Common/Edgar/1107332/1209191-07-5…

[GuHu1]

bericht in voller länge siehe link:

http://online.barrons.com/article/SB119317405079968867.html?…

Merrill Woes Suggest Trouble for U.S. Economy

........Dendreon, a biotechnology company that has attracted so much options trading interest these past months due to its cancer drugs, is expected by one major investor to trade to gain about 63% by January.

With the stock at $7.68, this investor sold on Tuesday 35,000 January 12.50 calls, and bought 20,000 January 10 calls, creating a "bull spread." This type of strategy is often used when investors think a stock may trade within a range. What makes this trade unusual is the size of the spread, which is particularly large given that Dendreon has a market capitalization of only $650 million, which is particularly small. In that context, the bull spread seems like a big bet made by an aggressive hedge fund perhaps in anticipation of a drug study results.

The trade is extremely aggressive, and essentially looks for Dendreon stock to behave in a fashion at odds with its current trajectory. Dendreon shares have fallen 54% in the past six months, though during the past three months the decline has slowed and the stock has traded sideway."

[GuHu1]

auszug aus IV

"Gold sold just enough after the panel that wouldn't raise much stink."

lol where'd you concoct that ridiculous notion from?
The Dope sold 20% at $13 (it then went OVER $25.00)

"If he had sold all of his shares just after the panel, that would have been definitly considered selling based on iside selling."

How do you come to the conclusion that ANY sale would have DEFINATELY been considered Insider selling? He, YOU, & the whole investment COMMUNITY were certain that the FDA would follow the panel's review & approve Provenge so don't sit there & lie to yourself & claim otherwise.

"He has run the company to the ground"

Oh really? How so?
His company was screwed by the FDA and you know it.
His company has been the target of bogus suits, illegal naked shorting, & a media campaign that would lead people to believe that his last name's Hitler.

How has Gold run the company to the ground?
By running years worth of trials that are a prerequisite for the scumbag FDA?
Tell me how he has run the company to the ground?

He's supposed to pump out bullshit PRs in the hopes of pumping the stock up so you can cash out of your big time 1,000 share position?!

Your frustration is so misguided, it's laughable.
Wake up.

He's gotten sandblasted at every turn.
& just when the FDA & big pharma & Milken & Proquest & UBS & every other predator thought that they could bury Dendreon & move on, Management secures enough financing to say "F*ck You all!" "We're not going anywhere"

Cry all you want, pal, but if you weren't so nearsighted & could actually see past the 4pm close everyday, you might just realize that DNDN won't be $7.50/share 8-12 months from now.

[NoSelters]

Von Pharmalot...


http://www.pharmalot.com/2007/10/who-wrote-the-mysterious-pr…


No

[GuHu1]

von AF :

http://tinyurl.com/27rfsq