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Biotech / Medical : Biotech Valuation
CRSP 55.08-2.9%Dec 26 9:30 AM EST
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To: Biomaven who wrote (14812)12/20/2004 1:14:12 PM
From: Sam Citron  Read Replies (2) of 52153
 
we are going to see companies think twice about conducting new Phase IV trials that might turn up something unpleasant

I thought that Phase 4 postapproval studies were required by the FDA in cases where a drug that appears safe in preapproval trials is later found to cause unexpected side effects when used more widely.

This is what I understand lead to the CLASS study published 9/13/00 in JAMA, with Pharmacia's disingenious omission of data from the second half of the study wherein 6 of the 7 serious gastrointestinal complications in patients taking Celebrex occurred.

Much worse than a omission of disclosure of a nonobvious material defect in a house by a seller, this kind of omission by a drug manufacturer directly causes forseeable injury or death to thousands of purchasers. Fraud is too kind a word for such behavior IMO.

Sam
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