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Re: falconer66a post# 131438

Wednesday, 11/22/2017 8:37:44 AM

Wednesday, November 22, 2017 8:37:44 AM

Post# of 465852
Falconer, can you address a simple question for me. That is, if I can write one.

Ref. Dr. Peter Senge model on 3 levels of knowledge(what we know, what we know we do not know and what we do not know we do not know). These trials work at and learning occurs at the interface between what we know we know and what we know we do not know. As the learning process works(trials progress) new questions will continuously arise, it comes w/the turf & learning.

Dr. M. has often said he wants to ensure a pass outcome, presumably by managing this interface (what to evaluate and why). He now has AI tools and risk tools to help w/what and how to measure/set criteria, including gut and DNA variables as complexity begets complexity.

He obviously wants to understand if A2-73 is effective, why is it effective?
The old school of run the trial and see what happens is just not good enough. How can pass/fail be set? IMO his cautious responses are to be expected at this point. How can he and FDA get on same track?
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