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Biotech / Medical : Biotech Valuation
CRSP 50.19+1.8%Nov 21 9:30 AM EST

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From: zeta19613/29/2007 12:29:17 PM
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DNDN AC meeting..I tuned in when FDA statisticians were giving presentations..although they pointed out the technical stat issues..they had no conviction that they should prevent approval..opposite, I thought..they mentioned OS being gold standard regardless that it wasn't an initial endpoint, that their sensitivity tests did NOT indicate a false good bias in the OS in 9901 which did show stat sig for OS..one of the panel members brought up it's now known that TTP and PFS are not good indicators of OS in prostate cancer and the FDA rep reminded that this study was planned in 1998..

Edit: This meeting is in stark contrast to ODAC 04 with GNTA/ALTH..no acrimony,

I'd buy some shares if it wasn't halted..adcocates are speaking now..
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