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Biotech / Medical : Biotech Valuation

CRSP 58.08

+0.9%

Dec 11 3:59 PM EST

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To: Volcano888 who wrote (3492)	4/20/2001 5:31:01 PM
From: Biomaven	Read Replies (1) of 52153

Volcano, The FDA inner workings are not normally publicized. The advisory committee by contrast is public, and the transcripts of, e.g., the Aslera meeting will eventually be posted on the web. If you have never read an AC meeting transcript I urge you to do so - they are very educational indeed. (An interesting and still topical one was the original review of SCIOS's Natrecor). I don't know what the "straw poll" refers to - likely it was at the AC meeting. If so, and if it was on the record, the details will appear in the transcript. As you say, the final decision is made by the FDA, not the AC. Basically I believe it is the Office of Review Management at the CDER within the FDA that typically make the decision, although on controversial drugs it may go higher and involve the Commissioner. Some of the drug approval procedure is discussed at the FDA site. Take a look at: fda.gov Peter

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