Anavex Life Sciences Corp (AVXL)

[falconer66a]

Anavex is the real deal, by multiples.

Falconer is real deal.

Thanks. But the real deal is Anavex Life Sciences Corp, ever more so now with the AV1099 pain patent.

When I learned of Anavex back in the last decade, the story was pretty much just Anavex 2-73 and Alzheimer's. Very early data from both animals and humans showed powerful, unique biochemical mechanisms to treat central nervous system diseases. As a biologist I read all of those papers (most in murines, lab rodents) trying to find the errors. CNS diseases in general, and Alzheimer's specifically, are exceptionally hard to successfully treat. Most treatments merely try to suppress symptoms; underlying etiologies (causes) continue unhindered, to a lethal end. That wasn't case in the early pre-clinical studies; nor in the first human studies. There was something significant about Anavex. It was the rather newly-discovered biology, function of this sigma-1 receptor protein, and, specifically, how certain Anavex molecules could uniquely activate it, producing a multitude of downstream, consequent good results. On the face of it, too good to be true.

Well, we know how all of that has played out in the last five years or so. Added as a therapeutic target was Parkinson's disease dementia; now with continuing, even concluding human trials.

Because I have a neurological disease, hereditary spastic paraplegia (HSP), where muscles in my legs are spastic, stiff, from a deficiency of gamma-aminobutyric acid (GABA), I took particular interest in what happened when blarcamesine (formerly Anavex 2-73) was administered to girls with Rett syndrome. It increased their GABA levels, and suppressed glutamate. For me (and others with HSP), when approved, blarcamesine will be a profound therapy.

Then rather recently was the targeting of fragile-X syndrome. Very significant data there, too. Clinical trials in humans will be successful.

And just now, Anavex analgesia applications are on the table.

And there are human data showing very helpful facilitation of sleep by the drug. Sleep disturbances are significant, compounding complications of many or most CNS diseases.

But in every murine or human trial, the Anavex sigma-1 receptor agonists have produced no disqualifying or complicating side effects. Extremely rare for drugs acting so powerfully in the CNS. The Anavex drugs are remarkably safe, and are effective in moderate to very low doses; administered orally. Unlike with other CNS drugs, chronic (long-term) dosings in murines (and now humans) evoke no adverse events of consequence.

It can be understood why outsiders, those who have not diligently studied all of the clinical data on the Anavex molecules, will summarily dismiss both the drugs themselves, and the company. They've never heard of tiny little Anavex Life Sciences Corp, who thinks it can out compete Biogen and all the other Big Pharmas who have spent billions on the diseases Anavex is targeting with their "unproven" drugs.

Those respective perspectives will continue unchanged until the FDA (in the US) or the Therapeutic Goods Administration (in Australia) finally approves an Anavex drug for sale and therapeutic use. When that happens, probably toward the end of this year, or sometime in 2022, the questions about the company and its drugs will be rendered mute. CNS (and other) diseases will be successfully treated. A diversity of new applications (insomnia, pain, mitochondrial dysfunction, et al.) will emerge. Anavex will change 21st-century medicine as much or more than did antibiotics in the last century.

Those of us who understand Anavex biology and its applications will be holding our AVXL positions on out. In three to five years, when the curve of Anavex successes begins to inflect along a high horizontal asymptote, the company will be worth many billions of dollars. Worth waiting for.

Ethically, and far more important, will be the improvement of the quality of life for hundreds of millions of people across the globe.

For those who doubt, just watch. Learn, see how Anavex is, indeed, so different.