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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Volcano888 who wrote (3492)4/20/2001 5:15:47 PM
From: aknahow  Respond to of 52153
 
Online non financial part of XOMA annual report. Information on Xanelim the DNA psoriasis drug plus other efforts. Regardless of what one thinks of XOMA, if one thinks Genentech has a winner with Xanelim, then XOMA provides more leverage. Not sure more leverage is needed with biotechs but..... <g>

xoma.com

Xoma which is widely disliked by many knowledgeable posters on S.I. has acquired an institutional following, up from about 2% a year ago to over 37% of the outstanding shares. It has put in a strong technical performance recently. As one of the non knowledgeable S.I. posters I like XOMA and have a position. Bent over, is what some might call it. <g>



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