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


To: zeta1961 who wrote (23354)3/29/2007 3:56:23 PM
From: zeta1961  Read Replies (1) | Respond to of 52153
 
Final vote question: "Is there substantial evidence that product works?"

13-4 with proviso that 9902B is completed and efforts to recruit from minority populations..



To: zeta1961 who wrote (23354)3/29/2007 7:00:04 PM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
Much appreciate this Elisabeth - nice to get the running commentary.

Now I wonder what the FDA will do here - it's not a foregone conclusion they will approve the drug although there clearly will be pressure for them to do so.

I guess the shorts underestimated the impact of the hard survival data here. At the end of the day that's an unarguable endpoint - the PFS and other pre-specified surrogates specified in the trial are all very well in theory but are weakly linked to survival.

Peter