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Re: iwfal post# 92295

Friday, 09/14/2012 1:11:54 PM

Friday, September 14, 2012 1:11:54 PM

Post# of 346050
I think the trial size is just too small to really say anything about regional effects. With only about 40 patients per arm,
and assuming 50% are US and 50% not, there will be a lot of variability due to small sample size.
In addition, the issue here is moot since the MOA of bavi does not depend on the amount of expression of
certain cell receptors as in most targeted therapies, which might have a ethnic dependence. There
might be an underlying response to the chemo drug used which has an ethnic genetic dependence,
but since PS is increased on the tumor vasculature due to the conditions that exist because of the tumor itself
I don't see any reason bavi shouldn't work the same way on Asians, as non-Asians.
Given that Peregrine, and its partner, want to sell bavi in a global market I would think the best thing to
do is to run a trial with a balanced mixture of patients from around the world, at least from the largest potential markets,
so I find this whole argument pointless.
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