Anavex Life Sciences Corp (AVXL)

[falconer66a]

This is a new biotech stock. No guarantees.

As doc had mentioned there is not even any guarantee that we are powered enough for approval in AD; PD is going to take a while, and RETT which was touted as getting approval by mid 2022 is now looking at mid 2023 at best. How is that going to translate to a higher share price.

Very good question.

First, it doesn’t take an advanced degree to accurately proclaim that “there is not even any guarantee that we are powered enough for approval in AD.” The power that gets blarcamesine approved by the FDA (or other regulatory agency) for Alzheimer’s disease is only one thing, which neither the doc nor anyone else has yet seen — the top line data from the big, long Phase 3 clinical trial of the drug, which will appear only after the trial is completed and detailed analyses of its findings are compiled. My investments in Anavex Life Sciences Corp (AVXL shares) were never purchased on the belief that there was some pre-existing ‘guarantee of approval.’ Stay real. With Anavex we are dealing a new, start-up drug company working on entirely new drugs, with heretofore unknown mechanisms of action, against the most recalcitrant central nervous system diseases. On the face of it, pretty risky stuff, with no “guarantees.”

So, indeed, how can “any of that” translate to a higher share price? Again, only one way; by having the clinical results reveal (with statistically significant findings) that the drug is both safe and yields useful therapeutic improvements over any of the existing drugs for the tested disease (in this case, Alzheimer’s). I, as have others, have checked the info on the existing Alzheimer’s drugs (https://www.alz.org/alzheimers-dementia/treatments/medications-for-memory). When considering the preclinical murine (lab rodent) and early human trials (Phase 1), blarcamesine yields very positive outcomes.

Then, of course, is blarcamesine’s unique mechanism of action (MOA). It is not a cholinesterase inhibitor. It works very differently from Donepezil (Aricept®), Rivastigmine (Exelon®), or Galantamine (Razadyne®), the most commonly prescribed drugs for Alzheimer’s. At best, those drugs merely slow, for a time (not always long) the otherwise lethal progression of the disease. That’s not what happened with blarcamesine in transgenic rats with human Alzheimer’s disease genes or symptoms.

But, of course, mice (or rats) are not men (people). Real double-blind clinical trails, with statistically significant results data will be needed. The speculations of medical professionals (the doc) or former high school biology teachers (me) will play no part in the FDA’s decision on blarcamesine — thankfully. Only stat-sig clinical data will count. Those will appear sometime in the future. Until then, we are all speculating.

Of course, those harboring any anxiety about blarcamesine’s future ought to just sit back and be entertained by the postings on this board, good and bad. Keep stock investment dollars safe, in a proven mutual fund, CD, government bond, or cash.

Or, with discretionary funds, take a small AVXL position. By the end of 2023, all of the questions previously posed will have answers.