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Biotech / Medical : Biotech Valuation
CRSP 55.11-2.6%Nov 7 9:30 AM EST
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To: scaram(o)uche who wrote (7480)12/11/2002 12:16:26 PM
From: Biomaven  Read Replies (2) of 52153
 
And what the heck just happened with FRX??!!

I've seen a report from Cowen (thanks, S!) that says the key issue was once-a-day dosing versus twice-a-day. The FDA was apparently prepared to approve twice-daily dosing, but the company felt that this would make the drug non-competitive. (It has once-a-day dosing everywhere else in the world). There was also a suggestion that the FDA wanted the company to explore a higher dose to treat patients who are presently refractory to existing treatment. The original NDA package apparently had little or no dose-response data, and four out of the five trials were European. ("We here at the FDA noted with dismay that none of the European trials were stratified for foie gras consumption, a well known European-specific risk factor.")

Peter
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