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Re: gestalt2 post# 13787

Tuesday, 04/18/2017 7:51:30 PM

Tuesday, April 18, 2017 7:51:30 PM

Post# of 233151
2016 was a year spent negotiating with the FDA to reduce patients from 300 to 150 to 30. If we were stuck with enrolling 300 patients with the complexity of the Adjunct protocol we would never make it to the finish line. FDA realized that 300 and even 150 patients was unreasonable. So was it a lost year? Yes in terms of our expectations at the time. In hindsight I think not. I'll take a lost year and in exchange for an adjustment of 270 patients. Thats the difference in being able to complete enrollment and being out of business. FDA wants to give little Cytodyn a fair shot because the science warrants that type of consideration.

The takeaway today was the reality of where we are and what we can expect in terms of timelines and $'s to get there. We just went from the minor league to the majors in terms of experience and execution. I really believe this message boards opinions had an impact on the promotion of Tony C. No defensiveness. All questions were addressed in a professional way. I feel like we are under a new administration. Tony has more resources than meet the eye and as a successful executive he knows how to utilize the different skill sets and grow the team. I'm more bullish than I have ever been.
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