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nidan7500

11/03/23 10:30 AM

#437974 RE: Jonjones325 #437971

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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attilathehunt

11/03/23 1:45 PM

#438004 RE: Jonjones325 #437971

"They need to educate the FDA"

That's funny...All the brains that were at the FDA are now with Chris.

He is so smart that he was able to hire all of their top brass.