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Biotech / Medical : Biotech Valuation

CRSP 56.68

-2.4%

Dec 12 9:30 AM EST

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To: Harold Engstrom who wrote (5328)	1/4/2002 1:59:59 PM
From: Biomaven	Read Replies (2) of 52153

proving patients are refractory is hard to prove Well there's a big difference between convincing you or me and proving it to the FDA. There's no "bright line" definition of refractoriness. I would assume the FDA will look at the actual data for at least some patients to see if they agree with the categorizations made by the IRC. Knowing the FDA, they will doubtless quibble with at least some of the categorizations. Remember this wasn't a traditional double blind trial (and there's only one pivotal trial), so the FDA will (rightly) scrutinize their data very hard. I had assumed BMY did so as well - time will tell if they did so satisfactorily or not. Peter

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