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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: squetch who wrote (3662)12/6/1997 2:44:00 PM
From: Andrew H  Read Replies (1) of 9719
 
>>And, said Penhoet, now the FDA modernization act urges the agency to accept one major trial as proof of a drug's efficacy and safety.<<

This is interesting. Yes, that is the new policy, but the problem is not that the company doesn't have one trial showing efficacy, but that they have two trials, one which shows efficacy and one which shows no efficacy.

But you have to admit that this is the first biotech that seems to be giving the FDA a tough time.
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