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crescentmotor

08/22/22 10:00 AM

#371283 RE: LakeshoreLeo1953 #371276

How about data release which does NOT depend on derivative
examination?



100% agree--no "contextualization" wanted or needed. We need results that are so good that no doubts/questions are even raised to get FDA approval off the 509 patient trial, with or without a confirmatory trial.
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Steady_T

08/22/22 1:45 PM

#371306 RE: LakeshoreLeo1953 #371276

Key phrase in your sentence, Investigative science.
There are the trial goals specified as the primary and secondary endpoints. Then there is the investigative science specified as other endpoints and the resulting analysis including KEM.

Anavex is accomplishing multiple things in their trials. They are moving the trial process forward and doing research into the MOA and the disease processes.