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

To: Elmer who wrote (5396)	1/10/2002 1:18:52 PM
From: Biomaven	Respond to of 52153

Is that rate sufficient for approval on its own? They aren't applying for approval on its own. 10.5% response in a population that was really proven refractory to everything else might conceivably be enough. I don't know what the patient population was that produced that rate, though. Peter

To: Elmer who wrote (5396)	1/10/2002 8:53:21 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 52153

RR is surrogate end-point, but for refractory CC it may indicate progression free time, progression rate, survival and overall medical benefit. FDA is AFRAID of potential huge off-label usage, without clear evidence what is drug doing on its own, synergy with chemo (and dose applicable), and most important COMBINED side effects. Why so many dead after 30 days? 21/120 is ~18%. This is HUGGEEEEE! As I said, it is not Rituxan for single indication. Oncologists will be on their own, experimenting with unknown! Miljenko