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Astavakra

01/24/14 10:43 AM

#3602 RE: flipper44 #3598

Thanks for the useful link, Flipper. I agree with

However, its my view that the interim analysis for this phase 3 trial has predetermined stopping points for efficacy that were agreed upon by the sponsor, company and the FDA back on May 17, 2012.


This study seems to me to be very, very carefully planned and designed. With all of the contingencies built in that Linda has often alluded to, it would really surprise me if those discussions with FDA you mention didn't take place.