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Re: ChrisMissing post# 162419

Friday, 08/10/2018 4:11:00 PM

Friday, August 10, 2018 4:11:00 PM

Post# of 458802
brichnyc

what is that inflection point where the lights go on for Wall Street



Such a great question. I am not trying to answer it but want to make a point around what IMO is happening.

When investors see the risk equation has turned a corner they will relax and become AVXL believers/buyers. The position I hear Dr.M. taking addresses risk. He is saying that he now has a process which he can manage to predict an outcome with a confidence level approaching certainty. Old trial methods were crap shoots, we all can see that they might produce an acceptable outcome if the field of CNS variables was low. Never gonna happen. Now M. is saying he has a set of process controls and specific pt.parameters which he will manage to and that he is certain of the outcome. He is not validating an hypothesis, he is verifying by provision of objective evidence that specified requirements have been met. When the requirements have been met then the CNS condition of AD cannot exist. The leap here is brilliant, (other CNS diseases hopefully also). He is saying that AD* is treatable. (*scope to be confirmed)

When investors understand the facts based on provision of objective evidence they will see that reproducibility always follows w/controls. There is no hypothesis to prove. 21CFR part 820.3 2aa :"Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled."

The AD bar is set very low, some investors will see the solution early. This is progress since we have moved from," there is no treatment for AD", to some risk variable discussion. When the science begins to be discussed and understood by more investors the uncertainty will decrease as more information/results becomes available.
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