Replies to post #492728 on Anavex Life Sciences Corp (AVXL)

[sab63090]

jfk

I'll let Falconer reply to you on the questions you asked, however you do know about the lawsuit (based on the supposedly RETT "failure") was dismissed by the judge, I.e. thrown in the trash can, right????

[falconer66a]

My View of Anavex’s Future Successes

Falconer,66a what gives you confidence that the AVXL [clinical] test protocols for various indications are sound and will pass muster when the results are received? Majority of ALZ company trial results are negated due to poor design (thinking about INMB today, and AVXL's Rett).

Very good questions, ones whose answers cause me to maintain my AVXL position of several thousand shares.

First, are or will the clinical tests of Anavex’s candidate drugs be able to cause either the FDA (in the U.S.) or the EMA, European Medicines Agency, to authorize the sale of the drugs?

In this regard was the apparent failure of blarcamesine to yield safe efficacies for the symptoms of Rett syndrome. Clinical results were not sufficient to cause the FDA to authorize the drug for that congenital genetic pathology. Did the drug fail because it simply doesn’t work for Rett? Or, did Anavex conduct a trial with inadequate numbers of participants, where because of the inadequate numbers of trial participants statistical significance, showing authentic efficacy and safety, was mathematically not attained?

For whatever the reason, whether corporate error in the trial’s design and participation, or because the drug simply does not work to treat Rett syndrome, until some distance time in the future (or, perhaps never), Rett will not be a pathology Anavex will target. There are others far more promising. Those are the ones I have confidence in.

Personally, I’m most excited about Anavex’s targeting of schizophrenia, with Anavex 3-71. The apparent trial design errors of Rett syndrome will not be replicated. Just the opposite. Unlike Rett syndrome, a recognized rare disease, in 2023 approximately 3.7 million American adults reported experiencing schizophrenia spectrum disorders. Anavex will have ample numbers of physicians and their schizophrenic patients to provide statistical significance in the trial. Big n-numbers, to produce valid and confirmatory p-values.

Because Anavex 3-71 will be administered as a daily pill or two; none of the difficulties of institutional drug infusions will complicate the study.

Lastly, and most important will be the timeliness of the study. Results should start to appear soon after doses start. And there are recognized diagnostic metrics that accurately quantify the severity or presence of schizophrenia symptoms. Efficacies will be both quantified by the trial’s metrics and also frankly observed by both patients and their physicians and families.

Lastly, and originally, there will be blarcamesine being approved to treat or prevent Alzheimer’s. The MOAs, mechanisms of actions of blarcamesine working in transgenic lab animals, with the human genetics and symptoms of Alzheimer’s, are now clearly understood and observed. Those data, along with the ample human trials data for blarcamesine against Alzheimer’s are being presented to the European Medicines Agency, for their eventual approval of the drug. There are a number of drugs that have been approved (by the FDA) to treat Alzheimer’s. But they don’t work very well, are extremely expensive, and have ominous side effects.

Dr. Missling has intelligently taken the blarcamesine approval matter across the pond, to the EMA. For a number reasons I won’t delineate here, I fully expect EMA approval of blarcamesine for Alzheimer’s when the current approval process is complete (who knows when). The EMA professionals will scrutinize and understand blarcamesine’s MOAs; how the drug actually facilitates and modulates waste-clearing autophagy in neurons, thereby clearing or preventing the misfolded waste proteins, beta-amyloids and tau tangles, that disable brain neurons and cause Alzheimer’s lethal symptoms.

Finally, as readers familiar with my postings know, I look most distantly to the time when it becomes clear, from those taking blarcamesine that the drug not only treats or prevents the onset of senile dementia but exhibits a diversity of other anti-aging outcomes. Simply, eventually millions upon millions, globally, starting in middle age, will be taking a daily Anavex pill (probably Anavex 3-71) to attain good health in declining years. The profound Anavex anti-aging prophylaxis factor.

If I’m wrong, I’ll be out a few thousands of dollars; discretionary dollars from my budget I used to take my AVXL position way back, when shares were a lot cheaper. If I’m right, my family and estate beneficiaries will be amply rewarded. Far more important, however, will be the lives of millions spared the debilitations the Anavex drugs will prevent or successfully treat.

May it be so.