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Response to DNDN

I will be responding by e-mail to the person submitting the the last question about DNDN, as it is a part of the Buy List of my newsletter, the ChangeWave Biotech Investor.

It's only fair my response be limited to subscribers.

Comments (3)

Bill Poppe:

Michael, Thanks for your detailed response to my five Dendreon questions. I feel very fortunate to have some access to your sharp insight. Let me share with you a seekingalpha.com e-mail I received today regarding DNDN :

[[["Dendreon: Expecting Stock Appreciation On Upcoming Provenge Decision"

Notable Calls submits: Banc of America has some positive comments on Dendreon (NASDAQ:DNDN) saying they anticipate an approval decision on Provenge by May 15th, under the condition of completing the Ph III IMPACT trial, and expect potential stock price appreciation in the near term. This view is based on firm's recent interviews with an ex-FDA general counsel, a regulatory executive in a major pharmaceutical company and CBER panel members.

Despite questionable statistical data, the decision remains highly political and given the safety profile, CBER appears motivated to approve additional products to stimulate R&D activities in cancer immunotherapy. BAC notes that Jesse Goodman, Director of CBER, appears to have influenced Celia Witten to 'lower the bar' by changing the efficacy question during the initial advisory panel voting and believe it is a good indicator of CBER's intentions.

Firm understands that DNDN is well prepared for a potential launch and believe Provenge can be out on the market by late 2007. If approved, they see potential upside to their TP to $29 and if an approvable letter is received potential downside to $6. Maintains Neutral as they remain cautious about the outcome of the IMPACT trial.

Notablecalls: DNDN was in play yesterday and I suspect this note by BAC's William Ho will create some additional buy interest in the name. Mr. Ho assigns a 2:1 (66%) probability to the approval. I suspect DNDN can move past the $18 level today.]]]

Thanks again, Bill Poppe

NT:

OK. Lets just for a second assume the FDA approves Provenge under the condition that Dendreon will complete the IMPACT trial.

Frankly, I see the above scenario as very likely *but* is it just me that believes that IF Provenge gets approved under the above condition, the IMPACT trial may never finish?

If I'm a patient and Provenge's in the Market already why would I want to participate in the trial? How ethical would it be to have patients on Placebo when the drug's already in the market?

Cheers

Bill Poppe:

Michael,

Great work on DNDN. The market is starting to get the picture. Thank you.

A question for you on Cypress Bioscience (CYPR). Zack's has a one-page description w/ the following:
Cypress Bioscience, Inc. is committed to be the innovator and leader in providing products that improve the treatment of Functional Somatic Syndromes and other central nervous system conditions. Cypress' strategy involves acquiring/in-licensing undervalued central nervous system active compounds and developing them for new indications. Its goal is to be the first to commercialize a product approved in the United States for the treatment of Fibromyalgia Syndrome, or FMS, the focus of our initial efforts in the area of Functional Somatic Syndromes.

They apparently run a lean operation with only 15 or so employees out of San Diego.
Their www.cypressbio.com website indicates that they are expecting an announcement this quarter. Are you at familiar with the company, this disease, trial data, and/or FDA leanings about Cypress Bioscience?

Thanks, Bill Poppe

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