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Re: Thurly post# 107210

Wednesday, 01/09/2013 7:06:21 PM

Wednesday, January 09, 2013 7:06:21 PM

Post# of 345971
Thurly, I agree that comparison with the mean of the historic control arms would
make more sense, at least to me. The trial has really become a single arm trial, but
randomized and double-blinded at the same time. However, there is the logic that the
original control arm if corrected by removing treatments with 1 mg/kg would result
in an even smaller MOS than 5.6 months. That is why I think whatever happened didn't make
much difference at all. If the only requirements for moving to phase 3 are that treatment
with bavi is safe, and there is good indication of efficacy, then I think it can happen.
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