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Friday, 12/09/2016 8:21:44 AM

Friday, December 09, 2016 8:21:44 AM

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falconer66a Thursday, 12/08/16 09:40:34 PM
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Observations of a small retail AVXL shareholder.

I thank everyone for their postings on this board. Varying viewpoints and perspectives, to be carefully read and considered by those of us with an interest or position in Anavex.

I’m a field biologist and biology instructor, reasonably familiar with the cellular biochemistry of the neuron. None of what I relate here should be construed as investment advice or encouragement; merely the perspectives of an informed small-time retail AVXL investor.

First, I believe and understand that Anavex’s Alzheimer’s treatment approach is unique and wholly different from any drug on the market or under development by any other company. This sets Anavex apart. Its story and future are entirely different from those of any other drug development or sales company. Comparisons with existing Alzheimer’s treatment drugs, about a dozen, with only three or four in common usage, are invalid. None of these have been able to effectively stop or reverse Alzheimer’s symptoms. They merely slow disease progression for a period (often only for a few weeks or months).

As I interpret the available clinical data, Anavex 2-73, in fact, stops symptomatic progression, keeping the disease from progressing to ever more debilitating stages. Yes, the clinical population sizes from which these results are derived are small; but statistically significant, and consistent across the populations. I’m convinced that any future clinical trials of Anavex 2-73 will merely further substantiate the molecule’s unique biochemistry, restoring defective neurons to “homeostasis,” a normalized, fully functioning status. This is accomplished by 2-73's ability to re-connect dislodged or poorly-connected endoplasmic reticula to mitochondria. This restores normalized protein folding in the endoplasmic reticula, creating fully- and normally-functioning reaction-controlling enzymes. With those, neurons will operate healthfully.

All of that is crucial. Other Alzheimer’s drugs attempt to remove A-beta plaques, or tau-tangles, waste protein accumulations found in all Alzheimer’s-affected neurons (but also, incongruously, often in fully healthy people, too). Millions of research dollars have been spent in perfecting and testing waste protein removal drugs; with no success. Many pharmaceutical companies and neurologists persist in this evermore useless pursuit. Anavex has a much better, cheaper, and effective approach. Cause neurons to synthesize functioning enzymes by facilitating normalized endoplasmic reticulum-mitochondria connections.

Another crucial clinical finding. Anavex 2-73 easily crosses the blood-brain barrier, efficiently diffusing into neurons. Few other drugs do this. This allows minimal dosages, in posted clinical trials between 10 and 50 milligrams per day, administered orally (not by injection). Ease of administration, effective in low doses. Extremely useful.

Then, on top of all of this — and it is crucial for FDA approval — Anavex 2-73 has had few or no adverse events in the posted clinical trials. No disqualifying side effects. This is exceptionally rare for any drug or chemical acting inside nerves and neurons. Anavex 2-73 easily gets into neurons, re-connects disconnected endoplasmic reticula with their associated mitochondria, and the neuron then functions normally — without untoward results.

With an understanding all of this I’m convinced the Food and Drug Administration will sooner or later authorize widespread clinical use of Anavex 2-73, at least at the start, for this seminal reason: Anavex 2-73 exceeds any Standard of Care (SOC) results for any existing Alzheimer’s treatment drug. They merely slow for a time (at best) the progression of symptoms. Anavx 2-73 stops symptomatic progression; meaning that if administered at the start of (or before) symptoms, the disease can be chronically suppressed and the patient maintained in a normal mental state. Anavex will become the new Standard of Care drug for Alzheimer’s. No competition.

Eventually, I see widespread prophylactic (preventative) use of 2-73. It may eventually be commonly administered to virtually everyone at the age of 50 or 60, keeping Alzheimer’s from ever developing. No side effects. A small, cheap protein, easily administered.

And, for an expanded story, consider 2-73's eventual treatment or prevention of Parkinson’s disease and other geriatric neurodegenerative diseases. Animal tests indicate equivalent efficacies.

In fact, I suffer (not badly) from hereditary spastic paraplegia (HSP), where the motor neurons of my spine are hyperactive, causing adductor muscles in my thighs to remain tight. I walk with difficulty (but no pain). There is a French report where transgenic rats, with the inserted genetic defect of my disease, were treated with Anavex 2-73 and their spasticity was resolved. Yes, I’m hoping that can eventually happen with me.

I won’t elaborate on the expansive pipeline of other molecules Anavex owns and is developing for other diseases. If only Anavex 2-73 comes to market the company will be a giant success (especially for those of us with equity positions). But I think Anavex 2-73 is the subject of only a few of the early chapters in the eventually more gigantic Anavex story.
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