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Re: Pyrrhonian post# 10633

Monday, 05/19/2014 2:40:49 PM

Monday, May 19, 2014 2:40:49 PM

Post# of 724828
Pyrr said.

Hey flip, I had a brief discussion with Larry on SA and he seemed to be of the same opinion as AVII that the DMC hadn't even begun looking at the data (though for differing reasons). -- PYRR



Thanks Pyrr. That would be a change in Smith's position from April 16, 2014. Of course he leaned toward anticipating a continuation recommendation, but he recognized the possibility of an efficacy finding. He all but completely rejected a futility finding.

All this in approximately a month or less from April 16, 2014.

Anyway, we are all making educated guesses as more time elapses, with more information about guidance, protocol and pathways like Accelerated Approval, Orphan Designation and other potential additional status changes.

I'm optimistic in believing the FDA is moving in the right direction, NWBO likely has good results in the primary group, there are probably positive trends in the relatively new pseudo group and patient advocate communities are working hard to make certain large institutions don't sit on their hands.


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