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Re: nidan7500 post# 285217

Thursday, 11/26/2020 1:15:36 PM

Thursday, November 26, 2020 1:15:36 PM

Post# of 458787

Keeping things focused w/a risk averse regulatory body is not easy. We will be required to present strong data from systems which have all been through and accepted BY FDA V&V processes. If not they could go on for many months just agreeing on how the trials and systems used were controlled and validated. Long story which takes time to get prepared for.




Nidan I woke up today wondering about if Anavex used the dementia data to support our Alzheimer’s trials MOA than if Actigraphy data is pretty strong couldnt they do the same and present a supporting case for the early anecdotal evidence seen in the “super 7” saying “ see, we have replicated this process with these biomarkers in a dose dependent model in support of our MOA when looking at RWE and RWD”. Thats possibly what this PDD trial and all future trials are all about, cross supporting our cellular homeostasis theory zigging and zagging back and forth all symptomatic relief points!

When is enough enough? Sure safety and sleep are big but golf game improving????? I cant even do that if you ran me as a placebo in 10 trials!
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