Anavex Life Sciences Corp (AVXL)

[falconer66a]

How blarcamesine gets approved is yet unknown.

Not sure why you would go down this road at this point. [Questioning the nefarious disqualification of blarcamesine by the FDA.]

Had no such intention. Was more of a parked in a parking lot viewpoint.

I’m hoping that clinical trial results will be the sole determinants of blarcamesine approval by the FDA.

But Aduhelm got “approved.” It will cost $56,000 for a year’s therapy for Alzheimer’s disease. Biogen, the maker of the drug, stands to make billions (as does Anavex, with blarcamesine).

But the clinical results of Aduhelm were very questionable; particularly the drug’s safety. Brain swelling was an “adverse event,” side effect. Then, like Aricept, an approved Alzheimer’s therapy drug, Aduhelm only slows, moderately, the lethal progression of Alzheimer’s. A lot of money for little benefit; along with the drug’s side effects. Unlike blarcamesine, they aren’t merely some short-lived headaches or an upset stomach. Brain swelling can be lethal.

I’m in the Cleveland, Ohio area; read that physicians at the Cleveland Clinic, a major, world-class medical center, do not intend to prescribe or use Aduhelm for their Alzheimer’s patients. Side effects too severe; therapeutic results too meager. Who to follow? The FDA (and Biogen), or the neurologists at the Cleveland Clinic?

But, in fact, Aduhelm’s approval by the FDA sets a precedent, where very questionable clinical results can be used to substantiate a new drug’s safety and efficacy, even when so meager or questionable, when the targeted disease is, itself, so severe, and nothing else seems to work. Approval out of desperation.

If the Aduhelm approval stands (no indication that it won’t), Anavex’s clinical data only have to match the meager ones from Biogen, for Adulhelm. With that scenario, I’d say “we got it.”

What will happen if the blarcamesine clinical Alzheimer’s results are even, just a bit, better than those of Aduhelm? It would stand to reason, then, that blarcamesine gets approved.

But, as implied in my earlier post, reason (the science, the clinical results) may not be the determining factors. For Aduhelm, those “reasons” remain in question (especially at the Cleveland Clinic, where the drug will be prohibited).