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Re: crescentmotor post# 396461

Saturday, 01/07/2023 9:49:59 AM

Saturday, January 07, 2023 9:49:59 AM

Post# of 462250
crescentmotor

Yes--but my point was centered on in what regulatory juridiction(s) should AVXL initially file for drug approval. It may well be that some jurisdictions may facilitate/hasten the regulatory approval process whereas other jurisidictions may, for whatever reason, throw up delays or even roadblocks. AVXL needs to test the water temperature before making the huge, time-consuming commitments that will be required. I am actually hoping the release of full data will trigger action by one or more of the regulatory jurisdictions.

....Totally agree....Dr.M. should/must keep the number of regulatory interfaces to a minimum...as few as possible.

We all recognize that life is complicated enough w/o adding yet another country's terms/interfaces/barriers...etc. Ideally, the FDA-US approvals would be granted based on trial-and other support results/data. Keep it as simple as possible. The obvious dilemma has been the complex(read corrupted) approvals by FDA to date. It looks like an FDA approval of A2-73 is a head shot to all the Amyloid Plaque based AD treatment alliances they now have in place and have supported for decades. An act of FDA Management MASS suicide

Are we expecting the FDA to do some kind of a DUAL TREATMENT Thesis approval? They (FDA top leadership) have put themselves in a box of their own design which is wired to blow up in their face unless there is some kind of..."NEVER MIND"...MOMENT by top FDA officials. Sad to say, unless Dr.M. can BLOW THE DOORS OFF THIS NEXT TLD_REPORTING session resulting in mass suicide by FDA leadership...then , the MULTIPLE-REGULATORY BODY PATH is our BEST ROUTE.

WE did not ask for this fight but we have it and must give the system our VERY BEST EFFORT .

The Most Famous Samurai Warrior..(Musashi) has written in his HOW TO...strategy papers called ..."Book of Five RINGS." "When being pursued by a powerful and confident opponent you MUST.."STOP and HIT HIM BETWEEN THE EYES AS HARD AS YOU CAN."


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