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Biotech / Medical : Biotech Valuation
CRSP 55.96+2.5%3:15 PM EST
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To: tom pope who wrote (13437)10/11/2004 11:12:23 AM
From: Biomaven  Read Replies (1) of 52153
 
could lead to gaming, if you have good phenotype data

I'm assuming that the resultant label would only have approval for the identifiable target population.

Hoff made the point that if you look at existing drugs, approvals were based on a very limited number of actual complete responses (between 6 and 80 with a median of 24) even though there were thousands of patients in the trials. So it's not crazy to say "bring us 25 CR's out of 275 patients" and we'll approve the drug.

Peter
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