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Biotech / Medical : CEPH
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To: WeirdPro Randy who wrote (584)3/13/1998 3:09:00 PM
From: Rudy Saucillo  Read Replies (1) of 998
 
This is great news, WeirdPro! I attended both of the previous Myo panels and can say that the AC members were not unsympathetic with the patients' efforts. The T-IND data to be reviewed is exactly what the AC expected previously.

I believe that (1) if CEPH presents the data without any statistical tricks, and (2) if the data is in the *least bit* positive, we'll see an approval recommendation followed quickly by FDA approval.

At this point I believe it's a coin toss given the data previously presented, but I'm hopeful.

Cheers!
Rudy
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