Anavex Life Sciences Corp (AVXL)

[falconer66a]

Then, even bigger things to follow.

Interesting that we have been discussing homeostasis as long as we have. Looking like the FDA may soon be convinced as well.

What will be convincing at the FDA will be the actual positive therapeutic outcomes from the three on-going (soon to be completed) human clinical trials. The clinical data will demand an explanation. Just how could Anavex's molecule, blarcamesine, have produced such positive results, when compared to existing drugs?

There won't be a mention of immunogenic removal of waste proteins, the Aduhelm mechanism of action (MOA). No reference to how Aricept slows (but does not stop) symptomatic progression.

Actually, the only two things the FDA needs to discover is if the drug provided therapeutic outcomes as good or better than SOC (standard of care) drugs; without untoward side effects. With those results, approval to sell and clinically utilize blarcamesine will happen.

But others will have to explain how Anavex succeeded. The FDA needs to know only that the drug worked, safely. The exact mechanisms of those successes don't have to be explained by the FDA in their approval announcement. Those will have to be provided by both Anavex itself, and the medical press. "New drug, with new action, approved to treat Alzheimer's." The medical press will have to go back and scrutinize the graphics and diagrams on the Anavex website. It's all there. They'll be saying pretty much what I just said in my first post. But it will be no longer conjectural. The clinical results will have validated the mechanisms.

Then, on to other diseases and conditions, with the other Anavex drugs. Anavex 3-71, I contend, will be even more important, safe, and effective, for an expanded spectrum of human diseases.

But eventually, the final Anavex Big Story will be the widespread use of Anavex drugs for prophylactic, disease-prevention uses.