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Jonjones325

10/28/23 2:52 PM

#437453 RE: Jonjones325 #437452

We have a game changing breakthrough science with a first timer CEO. That is the crux of the problem.

-First time leading a company
-First time doing trials
-First time trying to commercialize
-First time dealing with regulators
-First time dealing directly with shareholders
-etc. etc. etc.

Our science is too big for him. Experience in these areas matter.

Small mistakes because on inexperience matter at this level.

Who has Misslings ear in these matters? Yes, he has a board and a team with some expertise but not the seasoned battle tested expertise at a level we need to move forward.

Sometimes the job is just too big.

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abew4me

10/28/23 3:16 PM

#437454 RE: Jonjones325 #437452

I would think that there's a stronger case for FDA approval once the P2b/3 results have been published in a respective journal, no?
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scorman1

10/28/23 6:18 PM

#437469 RE: Jonjones325 #437452

the problem is that the data is confusing with"titration" meaning that all patients do NOT react well to specific doseages. There had been NO breakout of which doseages produce what clinical effect . The FDA wants clarity, not confusion. SAVA gave everyone the same dose pills to mild and moderate and reported all the data. BTW, 47% of all 216 patients in phase 2 with a cognitive gain of 4.7 points, which here would consider "super responders" if AVXL had bothered reported it, but conveniently hasn't