Anavex Life Sciences Corp (AVXL)

[falconer66a]

Well, not yet.

Yeow--did I hear someone say "We've got this" ??????

Well, from time to time, the phrase has been attributed to me. I don’t recall actually using those words; but my sentiments, evidenced-based, fit.

Presently, the topic is the possibility of Anavex getting FDA approval to sell blarcamesine to treat Parkinson’s disease dementia (PDD); a condition with a very poor prognosis. Nothing right now works to effectively treat it.

I, and others with biological expertise, who have scrutinized all of the data and information from earlier and existing human trials, stacked upon dense datasets from murine (lab rodent) trials, conclude that when presented with the data from the current human PDD trial the FDA will approve the drug.

So, do we have this? Well, not yet. The FDA hasn’t seen any clinical data from Anavex yet. But two imperative clinical results datasets will be delivered to the FDA, either late this year, or earlier in 2022. First will be the Rett syndrome clinical results dataset. Among other things, it will show profound reduction of glutamate, which otherwise causes untoward neuron hyperexcitabilty (muscle spasms, etc.). The drug at the same time increases of gamma-aminobutyric acid (GABA) levels. That important molecule does just the opposite; turns town neuron hyperexcitability. With these two results, alone, Rett syndrome symptoms will be markedly weakened.

Of course, blarcamesine does a number of other good things for the girls with Rett, too. It will be approved by the FDA, and Anavex will promptly initiate sales of the drug.

But much larger will be the blarcamesine market targeting PDD. Rett is a rare disease. For PDD, from 50 to 80% of people with Parkinson’s disease go on to suffer from its dementia.

So, right now, no, we (AVXL shareholders) “don’t have it.” But after the FDA is confronted with the clinical results of the two blarcamesine clinical trials, we’ll have it well in hand (well, in our brokerage accounts). Late this fall, or first half of 2022.

Then, maybe early 2023, add in Alzheimer’s...!