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Biotech / Medical : Biotech Valuation
CRSP 55.11-2.6%Nov 7 9:30 AM EST
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To: Biomaven who wrote (15209)1/11/2005 6:58:44 PM
From: former_pgs  Read Replies (1) of 52153
 
>In response to your question, at some point the FDA is going to start grumbling about them trying to unblind the trial early. It's one thing if an investigator makes a comment, it's quite another if they systematically try to uncover this information. In fact I think they made some reference to this relating to looking at hair-loss among patients who had died.<

This CTIC situation solidifies my opinion that the sponsor of a registration directed phase III trial should not be receiving monthly updates on safety (ie. deaths). It would imply greater cost, but the IRB / DSMB should be renumerated to fill in the mandated FDA safety reports and submit them directly to the agency without the sponsor getting involved.

CTIC is making a game of their event accrual. Soon they'll put a counter up on their website.
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