Anavex Life Sciences Corp (AVXL)

[falconer66a]

Yes, but would like to see this with Alzheimer's symptoms.

Such as placebo-induced cognition improvements, enhanced sleep, all the other symptoms.

All of this will be resolved in the Phase 3 study. Right now, we are arguing to the question, as it were, of how many angles can dance on the head of a pin.

Fun, but of no real-world consequence. The real deal will be FDA approval of Anavex 2-73 for both Rett syndrome and Alzheimer's (others to follow).

And, because the Australian trial (and extensions) have allowed Anavex officials to detect and optimize dosing levels and frequencies, I believe there is a high chance for early termination of the Phase 3 trial.

The data from the two arms (control and experimental, placebo and real drug) will be blinded. Neither patients nor administering physicians and nurses will know what any of the patients in the trial will be ingesting. Both pills will look and taste the same. Only a computer will know.

And, FDA will, early on, crunch the trial data, internally correlating measured results with what was individually administered. When the blinded computer data reveal that those getting the actual Anavex 2-73 are all stabilized or improved after several months, and those on the non-drug control pill continue to symptomatically decline, in the universal manner of Alzheimer's patients, FDA is ethically obligated to terminate the study and approve the new drug. When computer-crunched data show all or the majority of those taking the real drug are stabilized or improving; while all of those on the disguised sugar pill continue to decline unabated, without any adverse effects (as shown in the Australian trial), medical ethics requires termination of the trial, so as not to further allow the deterioration of the health of the placebo arm of the study.

Instead of a year or more for the study, favorable early computer results from optimized dosing levels and frequencies in the new trial may bring it to an early, ethical termination; with FDA approval quickly to follow.

Such compassionate approval is not out of the question.