Anavex Life Sciences Corp (AVXL)

[falconer66a]

Yes, I’m increasingly hopeful that 2-73 can bring for me a more natural gait, etc.

The question of off-label usage hasn’t, to my knowledge, been much addressed or considered. Understandably, the primary therapeutic focus is on Alzheimer’s. Should 2-73 be therapeutic only for that disease, it (and Anavex) will be exceedingly successful. With a moderate but solid bit of emerging evidence, I’m hoping for that, at least.

What, however, might be the implications of FDA approval for, let’s say, Alzheimer’s at the beginning? Inasmuch as the molecule has failed in both murine (animal, mouse) and human trials to elicit objectionable side effects or adverse outcomes, I can see little reason practicing physicians might not eventually start off-label treatments for any number of diseases and conditions. “Take this. Let’s see what happens.”

Of course, when a physician does this he or see opens themselves up to monstrous tort actions. Medical tort lawyers will park the good doctor on the witness stand and force him or her to admit that standard medical practice simply does not yet support off-label usage of 2-73, and the adverse outcomes experienced by the lawyer’s client were a direct consequence of the physician’s inattention to safety and FDA recommendations, etc. The jury will find in favor of the aggrieved patient, of course.

So, before off-label usage begins, those receiving chronic 2-73 therapy must demonstrate safety, with few or no side effects.

Should that be the case — and I believe it will be — safe off-label use would then begin, against any number of diseases. As I posted, 2-73 already has demonstrated or projected favorable therapeutic outcomes for a wide spectrum of human diseases, including some unrelated to neurology.

As with everything related to this remarkable molecule and company, this is going to be fun to watch; and, perhaps, wonderfully rewarding to both patients and shareholders.