Anavex Life Sciences Corp (AVXL)

[falconer66a]

Blarcamesine will self-market itself.

I believe we will start a major marketing push in q4 to tell the world what we have.

Perhaps.

But, in fact, that may not be necessary. The clinical data themselves will spontaneously tell the then-validated Anavex story.

All of the “deficiencies” in previous blarcamesine clinical studies and results will be missing. First, this Alzheimer’s study was big, not thirty or forty participants; big enough that data are statistically reliable and valid. Previous Phase 1 and 2 studies could be dismissed as non-predictive; not enough participants; and, perhaps, not long enough. This trial is big (large N) participant number, and lengthy; long enough that results can’t be by mere happenstance.

And that will all be revealed by the P-values. In conventional, accepted biostatistics, to be valid (and accepted), results mustn’t have a greater chance of mere happenstance, chance results of any greater than 5%, one in twenty. The P-value must be 0.05 or less. Any results larger than 0.05 will disqualify whatever is being measured.

So, what if all of the P-values are <0.05? Simply, then, blarcamesine works; is a viable, useful Alzheimer’s disease therapeutic. No more questions, other than when and how can Alzheimer’s patients start their Anavex therapies?

Unlike Aduhelm, with its untoward brain swelling as a major “adverse event,” side effect, blarcamesine has never, in any of its clinical studies, whether in murines (lab rodents) or real humans, produced adverse events (AEs) of any debilitating consequence. The drug is profoundly safe; uncommon in drugs acting in the central nervous system. The clinical results will not reveal any disqualifying AEs.

So, what results can be problematic for Anavex? Only where symptoms have failed to be controlled, slowed or reversed, by blarcamesine. If blarcamesine is a failure, patients with Alzheimer’s taking it will, over the lengthy treatment period fail to show any improvements. That’s why big clinical studies must have two “arms,” test groups. About half of the study participants will have taken what they think is the drug, blarcamesine. The other half, too, will take what they think is the drug. But the study is “blinded.” The people actually taking the drug, in the “experimental arm,” will get the real drug. The other group, in the “placebo arm,” will take pills that look exactly like the real drug. But those pills will be primarily colored starch, the placebos. No one knows whose taking what until after the trial is completed (just recently). Then, computer coding will unblind the results, the two trial populations will have their results compared.

And that’s what will make big articles in major papers. “New Drug Shows Safe Efficacy Against Alzheimer’s.” Nothing more need be said. Every Alzheimer’s stakeholder, doctors, patients, care-givers, health insurance companies, etc. will scrutinize and devour the outcomes from the study. All of the articulated Anavex naysaying encountered on this stock investment message board in the last seven years will quietly fade into destined oblivion. Press releases from Anavex Life Sciences Corp will be fine. But even without them, the blarcamesine story will be globally validated. A new era in Alzheimer’s therapy, understood by all.