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Biotech / Medical : Biotech Valuation
CRSP 56.89+1.2%Jan 14 3:59 PM EST
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To: quidditch who wrote (10556)2/20/2004 10:28:14 PM
From: Biomaven  Read Replies (1) of 52153
 
"our opinion" that the new studies didn't confirm any tox signal or indicate other tox issues.

SEPR can't speak for the FDA - all they can do is give their own opinion. Everything is toxic at some dose level - there are no absolutes here. No way a company can (or should) be more definite on this issue than they in fact were. There is always risk in any NDA.

My bottom line is that this is an isomer of a very widely used drug with no dose increase.

Peter
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