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Biotech / Medical : Biotech Valuation

CRSP 56.68

-2.4%

3:59 PM EST

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To: Biomaven who wrote (14113)	11/15/2004 9:48:02 AM
From: bio_kruncher	Read Replies (1) of 52153

I had a chance to view a webinar last week on the VIOXX issue where an FDA person presented. They pointed out that the COX-2's were priority review drugs because of the GI safety issue. Sandy K. stated that at the time of review/approval there were 10,000 annual deaths attributed to NSAID related GI perforation and bleeding. They showed information about what and when they knew and what actions were occurring(planning new studies adjusting ongoing studies). On the whole I'd say they seemed to have done the right things. Only exception I'd say is that there was too long a period of 'discussion' about label changes (adding CV risk) after VIGOR trial. bk

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