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

To: tuck who wrote (5934)	3/18/2002 10:59:38 AM
From: Biomaven	Respond to of 52153

Note that the VPHM AC meeting info is available at the FDA site. Fairly neutral (and unusually skimpy) presentation of FDA briefing materials. The FDA raises a plec. side-effect issue not previously disclosed (to my knowledge): a moderate increase in menstrual disorders in women who were also taking oral contraceptives. The key issue (that Rick pointed to earlier) remains what the AC will make of the intent-to-treat group. No real hint in the materials of the FDA position on this. Bottom line is that the FDA seems to have tossed this one into the AC ring without much of a position themselves. The briefing report is certainly more positive than many I could have imagined them writing. Peter