Biotech Valuation Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biotech Valuation

CRSP 53.54

-3.1%

Nov 18 3:59 PM EST

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: The Dodgy Ticker who wrote (23366)	3/30/2007 10:34:40 AM
From: tuck	of 52153

In the case of companies moving with DNDN, one has to ask the question "Which AC will be reviewing the drug?" Based on the make-up of the committee reviewing Provenge, and on the play-by-play from IHub's "Biowatch" (who was in attendance) it seemed like a bit of a turf war. The very negative statistician was from CDER (Pazdur's arm)? The Committee Chairman, Dr. Witten, changed the pivotal question and swung the vote, apparently witihin regulations. DNDN should be grateful Provenge was not being reviewed by ODAC or CDER! I don't think it would have made it there. Another question, which I don't know the answer to: Who in the FDA reviews the AC decisions and actually approves/not approves the drug reviewed? TIA & Cheers to DNDN longs, Tuck

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next