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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (15209)	1/11/2005 5:03:30 PM
From: Biomaven	Respond to of 52153

And speaking of CTIC, APPX may not actually be a crazy play here. BMY and the like must surely be looking hard at them, and a deal may not be that far off. The economics are compelling from just the oncologist's viewpoint. Peter

To: Biomaven who wrote (15209)	1/11/2005 6:58:44 PM
From: former_pgs	Read Replies (1) \| Respond to 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.