Dendreon Corporation (DNDN) class-action?

The FDA Code... Many have said the FDA's response stunk more than a 7 year old Camembert. At the risk of being cheesy, one must admit that there are more holes in this FDA debacle then there would be in a Gruyere Cheese in Mickey Mouse Palace or if you don't get the previous reference, in a cop venturing into South Central without a bullet proof vest. If anyone has answers to the following, do post them in the interest of all cheese lovers and policemen in these times of hardship!
1/ Why was there no negotiations between the FDA & DNDN in the past 3 weeks?
2/ Why didn't the FDA reprimand drs. Hussain & Scher for their "leaked" letters or to the very least why didn't they issue a rectification letter to the press?
3/ Since Provenge answers an unmet need and poses insignificant side-effects in comparison to Taxotere, why didn't the FDA opt for immediate approval with ongoing accruance of the control group taking the placebo outside of the U.S.?
4/ In all of its history, this will be the first time the FDA turns down a candidate after it has received a positive recommendation from the advisory committee. Eschenbach himself has been very outspoken about his desire for the FDA to act as a "bridge" and expedite the process of candidate to market. On numerous instances, he had spoken very emphatically on the benefits of immunotherapy and how this new field would be a giant step towards victory in the fight against cancer.
5/ Why has the FDA issued a complete response asking vaguely for additional data on efficacy without specifying the exact nature of this data? And why do so in a letter before the deadline without first checking with DNDN whether the information is readily available or not?
6/ Provenge being a vaccin solution, conventional statistical time-line models pertaining to chemotherapy can not be indicative of efficacy. It takes time for the immune system to react to the vaccin. FDA scientists and statisticians are well aware of that. This being a new science, it can not be tested using ante-dated obsolete gauges. Yet, the FDA is postponing approval of Provenge until these antiquated conditions are met. Why apply an old method of measuring efficacy on a new solution requiring a new testing method? Why not adapt the testing method itself?
7/ Finally, taking into consideration DNDN's low cash flow, had the FDA really wanted the company to succeed, couldn't they have hinted at DNDN they were going to issue an approvable, giving DNDN an opportunity to operate a shelf at a high share price before the fall?
8/ And finally, why didn't the FDA postpone their decision rather than issuing an approvable knowing full well the effect this would have on the stock. They could have easily done so on the grounds that Provenge is a new solution and requires more talks and planning between the FDA and DNND?

Instead of all of the above, it turns out that there were no discussions and daily meetings between the FDA and DNDN, that so far, DNDN doesn't even know what exactly the FDA is asking them.
This puzzle has a lot of pieces missing and I suspect that even if we could somehow gather them all, the pieces would not fit together.
This is a case for Inspector Cluzot. Our man is flying from Barbados as I write. He just elucidated the case of the missing coconut crown! Let's all hope he will be as successful in lifting the veil of confusion from this whole FDA fiasco...

[wld_team]

Glancy Binkow & Goldberg LLP, Representing Shareholders of Dendreon Corporation, Announces Update to Shareholder Lawsuit -- DNDN

Friday June 29, 8:30 pm ET


LOS ANGELES, June 29, 2007 (PRIME NEWSWIRE) -- Glancy Binkow & Goldberg LLP -- representing shareholders of Dendreon Corporation -- announces 25 days remaining to move to be a lead plaintiff in the shareholder lawsuit. All persons and institutions who purchased or otherwise acquired the common stock of Dendreon Corporation (``Dendreon'' or the ``Company'') (NasdaqGM - DNDN - News) between March 30, 2007 and May 8, 2007, (the ``Class Period''), may move the Court not later than July 24, 2007, to serve as lead plaintiff; however, you must meet certain legal requirements.

If you wish to receive a copy of the Complaint, or have any questions concerning your rights or interests with respect to these matters, please contact Michael Goldberg, Esquire, of Glancy Binkow & Goldberg LLP, 1801 Avenue of the Stars, Suite 311, Los Angeles, California 90067, by telephone at (310) 201-9150, Toll Free at (888) 773-9224, or e-mail to info@glancylaw.com, or visit our website at http://www.glancylaw.com.

The Complaint charges Dendreon and the Company's chief executive officer with violations of federal securities laws. Among other things, plaintiff claims that defendants' material omissions and dissemination of materially false and misleading statements concerning the Company's performance and prospects caused Dendreon's stock price to become artificially inflated, inflicting damages on investors. Dendreon is a biotechnology company that engages in the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company's most advanced product candidate for FDA marketing approval is Provenge, an active cellular immunotherapy. The Complaint alleges that during the Class Period defendants failed to disclose or indicate, among other things, that: (i) study D9902A, a Phase III clinical trial for Provenge, was not a complete clinical trial due to the limited number of enrolled patients, and therefore it lacked complete statistical significance; (ii) as a result of the foregoing, study D9902A was not comparable to earlier studies; (iii) the Company's studies failed to show that Provenge slowed the spread of prostate cancer; (iv) the Company had significantly changed how it categorized in its financial statements a contract with Diosynth Biotechnology for commercial-scale quantities of antigen; and (v) this change in accounting allowed the Company to manipulate its financial statements and make Dendreon appear financially stronger and more attractive to investors.

On May 9, 2007, the Company disclosed that it had received from the FDA a Complete Response Letter, commonly referred to as an ``approvable'' letter, concerning approval of the Biologics License Application (BLA) for Provenge. The Company revealed that the FDA had requested additional clinical data in support of the efficacy claim contained in the BLA, as well as additional information concerning the chemistry, manufacturing and controls section of the BLA. This news shocked the market, causing Dendreon stock to plummet $11.41 per share -- a more than 69% drop -- to close on May 9, 2007 at $6.33 per share, on unusually heavy trading volume.

Plaintiff seeks to recover damages on behalf of Class members and is represented by Glancy Binkow & Goldberg LLP, a law firm with significant experience in prosecuting shareholder lawsuits, and substantial expertise in actions involving corporate fraud.

If you are a member of the Class described above, you may move the Court, not later than July 24, 2007, to serve as lead plaintiff, however, you must meet certain legal requirements. If you wish to discuss this action or have any questions concerning this Notice or your rights or interests with respect to these matters, please contact Michael Goldberg, Esquire, of Glancy Binkow & Goldberg LLP, 1801 Avenue of the Stars, Suite 311, Los Angeles, California 90067, by telephone at (310) 201-9150 or Toll Free at (888) 773-9224 or by e-mail to info@glancylaw.com.

More information on this and other class actions can be found on the Class Action Newsline at http://www.primenewswire.com/ca



Contact:
Glancy Binkow & Goldberg LLP, Los Angeles, CA
Lionel Z. Glancy
Michael Goldberg
(310) 201-9150
(888) 773-9224
info@glancylaw.com
www.glancylaw.com



Source: Glancy Binkow & Goldberg LLP