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nidan7500

10/13/21 10:55 AM

#332778 RE: imho #332766

Trying to get the FDA to accept Anavex's interpretation of the various third party studies that "suggest" the drug has merit, is what the whole thing is about and why there are no NDA's. Until then.

by imho.

One thing we have learned over time w/AVXL is that "nothing around here happens by accident..." .

IMO, the PR today is significant as it starts the next phase of a process being led-conceived by Dr.M. and staff. The really smart BP's are now seeing their worst nightmare come true before their eyes. They know what they have and how it contrasts and compares w/AVXL. They should have been expecting something like this. The forecasted TRIFECTA is alive and well (w/other new shinny things being added...thx the S1R as we should expect new learning along the way).

A meaningful and long learning process has been boiling on our back burner. As Dr. Peter Senge has reminded us...(3 stages of knowledge..."what we know and we know we know it.", "What we do not know and we know we do not know it", and "what we do not know we do not know". Senge suggests the learning process is sequential. Dr.M. and AVXL team are about to lead at the interface of the 3rd stage apply explosive new S1R data and knowledge/ new learning is inevitable. IMO.

We all know that learning is iterative. Evidence shows we are breaking out by jumping into phase 3 in Senge's model through application of real-time Phase 2 (as we speak) learning. (complicated-unpredictable process).

IMO, Dr.M. also know he cannot get there w/o FDA and WW regulatory body support. Sad to say there is a complex and corrupt system which we cannot have any confidence in (AKA "the herd"/BP/other.)

Looks to me like the RSD and PDD news/learning will be coming along shortly, if the Trifecta model is still in play.

xodcode

10/13/21 10:58 AM

#332779 RE: imho #332766

It is the FDA that will need to "data confirm" this hypothesis by approving A2-73 for public use.

In the meantime it remains "data suggests" which may well be a very powerful statement backed by a fair amount of data analysis, I'd bet.

Hey, how one interprets "data suggests" is why we have a market. Some interpret the phrase "data suggests" very positively, others negatively.