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Re: Jonjones325 post# 437971

Friday, 11/03/2023 10:30:05 AM

Friday, November 03, 2023 10:30:05 AM

Post# of 460102
jonjones325

Trial results on their own is not enough. They need to educate the FDA on our MoA and clearly explain and demonstrate how and why it works.



Agree jj325...IMO, the rules and the game must be reconsidered by the FDA if they are going to apply CNS (linked systems) in approvals cycles. The old school
stat thinking is simply not adequate to assess new levels of knowledge. In fact the simple statistical (pass/fail) thinking is long since obsolete but (IMO) they did not know what to do next to get an appreciation of CNS (Homeostasis-S1R) value added systems integration. Simple-old FDA statistical methods are not adequate in scope or purpose to assess where we are going and they knew it. Maybe now we can all begin to make some CNS progress and to understand (WHY) a CNS solution is/will be effective or not.
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