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Biotech / Medical : Introgen Therapeutics
INGN 6.570-1.9%Nov 20 3:59 PM EST
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To: Jibacoa who wrote (688)3/29/2007 12:02:37 PM
From: zeta1961Read Replies (1) of 802
 
Bernard, I would not be surprised if they recommend at the very least, conditional approval(unlike like approvable that the bears predict)..and if the stock wasn't halted, I'd place a bet that the outcome would be good..they have the 9902B at about 2/3 enrolled..

The FDA statisticians presented the stat theories of how DNDN wasted all alpha because their primary endpoint of TTP was not met, but indicated how because OS is the gold standard and impossible to 'fudge', that this was clinically meaningful..and none of the FDAs statistical sensitivity studies showed there was a bias leading to false good survival data..

There were more CVAs in the Provenge group but nobody on the panel made much of it since it was not signficant..

I don't see any acrimony between the panel and DNDN..this is the same committee that will listen to INGN..main reason I payed to view this one..
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