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Biotech / Medical : Biotech Valuation
CRSP 56.87-2.2%3:59 PM EST

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To: Elmer who wrote (5396)1/10/2002 8:53:21 PM
From: Miljenko Zuanic  Read Replies (1) 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
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