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Biotech / Medical : Aviron
AVIR 3.240-0.9%Oct 31 3:59 PM EST
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To: sim1 who wrote (615)7/27/2001 8:04:00 PM
From: A.J. Mullen  Read Replies (1) of 645
 
This is annoying. Someone posted that the FDA had issued new guidelines concerning statistical analyses; I think it was Peter on the Valuation thread. Those guidelines seemed simple, straight-forward, and reasonable to me. It seems from what we've read that the committee said "go back and do your homework the way you were told."

I hope it was less stark than that. Perhaps someone wanted, say, the data stratified in a particular way, and argued vociferously that this would be more demonstrative. Re-analysing the data shouldn't take too long, but I wonder how long it takes to reconvene a committee?

Ashley
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