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too simple

06/24/21 12:04 PM

#317092 RE: falconer66a #317087

Wow .! Thank you Falcon. That was very interesting and informative. Sorry that your time , but very much appreciated.
I do think the Australia [fda) tga is going to play a very large role in Avxl success ( providing it plays out successfully).
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nidan7500

06/24/21 12:10 PM

#317093 RE: falconer66a #317087

I think the FDA got off into the weeds when it began to follow statistical rationalization decision guidance. They should write the (trials/testing) process macro rules/laws and see that those are understood and followed.

How and why they ended up in the deep weeds of statistical rationalization w/BIIB should be a study in FDA case training of , "How to NOT DO pass/fail decisions when other stand alone results are inconclusive." HINT-HINT, the process is done and it is telling you the answer...and it is INCONCLUSIVE...READ FAIL....AKA...STOP DIGGING.

On another note, FDA leadership needs to have process guidance which (AT LEAST) requires FDA leadership to do a COMPULSARY process review and redo when you have not solved ANY problems after 30+ years of attempts.

AKA, The DEAD HORSE SYNDRONE.