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Re: flipper44 post# 6535

Tuesday, 03/18/2014 11:36:36 AM

Tuesday, March 18, 2014 11:36:36 AM

Post# of 704249
Thank you Flipper, this is a great evidence based response, though most of the supporting language states that the sponsor is conversing with the FDA rather than the DMC.

Therefore if Germany received interim efficacy data, than NWBO must also know. It seems much more likely that Germany was given the interim topline safety data and in gave approval based on safety+anecdotal efficacy observed in previous trials/uses.

This brings us back to the question of whether NWBO is legally required to release interim efficacy data x number of days after receiving it. If they do have the data and its good, but maybe not 100% bulletproof (given the higher bar set for PFS vs. OS), then the delay may be due NWBO conversing with FDA regarding whether FDA would accept a halt for efficacy this early in the trial.

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