Anavex Life Sciences Corp (AVXL)

[falconer66a]

Key will be Anavex's NDA background data.

I'm sure the co. knows what it has--will they continue pursueing targets for 2-73 or kind of abandon it with 3-71 in their arsenal ?????

Just how Anavex will move forward in regard to their two phenomenal new drug candidates remains to be seen. Of course, most of the work and clinical data (in humans) have been with blarcamesine. Presently, on the basis of both clinical trial subjects (both murine and human) and results, blarcamesine remains the leading Anavex new drug candidate.

But, as I've long contended, Anavex surely has private, unrevealed data and information on all of their candidate drugs. They know far more than they are revealing. Important trade secrets, information they, with NDAs (non-disclosure agreements) will share with potential commercial partners or collaborators; all in contention to reap some of the revenue rewards a collaboration will yield.

Right now, surely, the prime, most achievable corporate target will be attaining FDA approval for blarcamesine as a Rett syndrome therapy. When that happens, everything changes for Anavex. First, they will have significant annual sales revenues, which can support all sorts of new studies and collaborations; globally.

One of the most important outcomes of an FDA approval of blarcamesine for Rett will be its substantiation of the company's unique MOA, mechanism of action, of its proprietary molecules. Although there are plenty of good data, sigma-1 receptor activation is still regarded questionably by the "real experts" who never heard of it when in med school. Little girls with Rett, getting levels of symptomatic relief will be game-changing. This sigma-1 activation thing really does work; at least for Rett.

And that's what I failed to point out about today's new journal article about Alzheimer's prophylaxis (prevention) by Anavex 3-71 in lab rats. The study definitively proved that Anavex 3-71 prevented cognitive decline in rats with human Alzheimer's disease genes. The Anavex MOA actually worked, now, with a second molecule (and at far lower concentrations, in micrograms not milligrams).

Going forward, Anavex knows that, among other things, its molecules do favorably activate the sigma-1 receptor protein, producing a variety of propitious downstream effects and outcomes. In the company's hundreds of pages of background data, to be used in a New Drug Application (NDA) to the FDA, overwhelming evidence will be presented to show that not only does the candidate drug work, but exactly how it does; by its unique activation of the sigma-1 receptor protein. The NDA will be for the FDA reviewers a short-course introduction to sigma-1 receptor biology.