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

To: Harold Engstrom who wrote (5328)	1/4/2002 1:33:31 PM
From: hm	Respond to of 52153

>>Do you really think proving patients are refractory is hard to prove? << If the criteria for failure on drug X are robust (including dosing, treatment paradigm, outcome measures, washout period) & the data collection done well, then it shouldn't be overly difficult. My read of the IMCL situation is that they had problems documenting patient failures with the first-line therapy. I haven't seen anything suggesting that IMCL did not use appropriate criteria for failure. But if IMCL cannot document the treatment failures then, IMO, they will have to repeat the trial. Otherwise no way to be sure that they have sufficient data to support the proposed indication: for use following failure of the first-line therapy. This need for robust data should be doubly important in an approval dependent on a single pivotal efficacy trial. HM

To: Harold Engstrom who wrote (5328)	1/4/2002 1:59:59 PM
From: Biomaven	Read Replies (2) \| Respond to 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