Replies to post #414913 on Anavex Life Sciences Corp (AVXL)

[abew4me]

Good to hear. Thanks for clarifying.

[scorman1]

Seems to me people fail to read what is actually being communicated by Anavex.

Investor...you cannot be oblivious to the myopic view of the lead proponents of AVXL on this board here, who conveniently ignore any real competition from the likes of simufilam or ALZ801.
Note that the FDA is now promoting CMS trials, whereby OL is started first, so nobody is left out, then after a year of treatment for everybody, half are assigned placebo, half continuation of treatment, to see who progresses and who relapses.
Simufilam just completed the dosing of the last of 125 pts for the second six month of CMS.
IMHO,It will be dismissed here as a nothingburger, even tho it is a double blind trial of most of the "super-responders" who gained 4.7 points cognition and now to than 18 months longevity. Springer's youtube has testimonials of four pts who have exceeded 2 years and are fully functional which is not realistic for the untreated afflicted.The numbers will have topline results in 3Q of THIS YEAR. Once again, the FDA does NOT require that the phase 3 be completed, just filed and enrolled as covered in the SPA.
OH, wait, AVNX doesn't have an SPA for AD...they want to now discuss AA "soon". The only documentation that AVXL has filed with FDA and is in public record is for Rett, which should be a slam dunk for approval and for which I am holding my 15k original shares.

ALZ801 is also a pill, no Aria, no side effects and dramatic phase 2 results with an ongoing real phase 3 and a form of PM in that it functions on APOE4 only (15% of AD population)
"The ongoing Phase 3 APOLLOE4 trial (NCT04770220) is now seeking to confirm the findings of the Phase 2 trial (NCT04693520) among more than 300 Alzheimer’s patients who each have two APOE4 copies.

The Phase 2 trial will finish later this year, and APOLLOE4 is expected to finish in mid-2024. Alzheon plans to file for regulatory approval of ALZ-801 in 2024, with an expected commercial launch in 2025."

what members of this board have not articulated is that any PM trial requires huge screening efforts with an associated very long accrual time, and great parsing of the resulting clinical data which results in very small "n" numbers for successful cohorts making approval even more difficult than simply stating 47% of all patients achieved 4.7 improvement in Cogs score.

[Steady_T]

Maybe I'm being dense but a P3 going on while applying for AA or obtaining AA and then being required to run a P4 are functionally the same thing or very close to it.

Each case requires running a trial.

[WolfofMia]

Yea how can getting to market faster and making revenue faster be a good thing for any company?

Or is it not a good thing because it doesnt fit in the AD revenue model of 3-4 years from now?

Can anyone make this make sense to me?

Someone without the need to be correct to fit a narrative is preferred.

P4 trials are not a good thing. What I am describing and Anavex appears to be pursuing is much better.