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Re: jakedogman1 post# 112455

Monday, 02/18/2013 5:36:07 PM

Monday, February 18, 2013 5:36:07 PM

Post# of 347009
Good point and on the money.

Looking at the information objectively no safety issues and a 3mg arm which shows efficacy Bavi qualifies to proceed to Phase III IMHO. You need only show efficacy, not statistical significance. The reason is it is set up that way among other things is that it is understood by all concerned that achieving statistical significance is extremely expensive due to the large sample sizes required and that requiring that twice, in a Phase II in addition to a Phase III, would pretty much halt new drug development.

The only question we need to have answered is was or was not the 3mg arm efficacious. If so they move on to Phase III, if not then it is back to the drawing board.
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