Anavex Life Sciences Corp (AVXL)

[falconer66a]

Two perspectives: Before or after an FDA decision.

I hope this is sarcasm [My statement that “Until the FDA approves the drug, it is categorically and unconditionally unsafe and ineffective. Period. ”]

Well, of course, for me it is.

But for various and many parties, it is not. It is for them the contrived truth. For them, until the U.S. Food and Drug Administration formally approves the sale and therapeutic use of a new drug, especially one like blarcamesine, which Is novel and unique in its mechanisms of action (MOAs), the new drug is held to be “unproven,” “of unknown safety,” etc. Simply, an abundance of solid therapeutic evidence in both murines and humans is summarily discounted. For drugs like blarcamesine, the only people authorized and competent to know and pass on the factual realities are the people at the FDA that approve new drugs.

Of course, from a distance one can discern how that can actually work. The FDA approved Biogen’s Aduhelm as a new, innovative, effective (?) treatment for Alzheimer’s.

For those considering the value, present and future, of an AVXL position, it works out in two ways. For those of us who know the profound evidence of both safety and efficacy, from the many pre-clinical murine studies, followed up successfully with early-phase human clinical studies, we are confident that when any of the three existing clinical trials of blarcamesine conclude (for a) Rett syndrome, b) Parkinson’s disease dementia, or c) Alzheimer’s disease), there will be an abundance of favorable data to assure FDA approval.

Others, however, are reluctant to place any confidence in the existing pre-clinical data. Blarcamesine is unlike any other drug; it simply may not work in real humans with real CNS diseases. Too risky to make an early bet, by buying some AVXLs. Those diligent souls, bless their hearts (well, checking accounts) are going to wait until the FDA decides on the matter.

Two differing biotech investment strategies.