Anavex Life Sciences Corp (AVXL)

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Are the Aussies Still Getting Anavex Benefits?

Important question, but if negative not a game-ender.

Perhaps after an extended period, longer than the original quantified Phase1/Phase2 safety & tolerability trial, those continuing to take Anavex 2-73 fail to maintain baseline or increased cognition. Perhaps the drug works exceptionally well at the start, and for some good period thereafter (many months, to a year or more), efficacy then fades and the disease symptoms resume. If so, so unfortunate.

But even if this were the course of Anavex 2-73 Alzheimer's therapy, it would not negate or prevent FDA approval of the drug. As noted in a previous post, to get approved for Alzheimer's treatment, Anavex 2-73 must do two things: have superior efficacy compared to the few approved Alzheimer's drugs on the market, and have a superior safety profile.

The latter was well-demonstrated in the Aussie trial. And already, those continuing to successfully take the drug in the post-trial period demonstrate a superior efficacy profile. Existing drugs work for but a few weeks or months.

Our best hope, both for AVXL shareholders and future Anavex users is for perpetuating, continuing suppression of Alzheimer's symptoms. All existing evidence, both murine (rats and mice) and human, points in this direction.

But even if efficacy eventually fades, the drug will be superior to anything presently on the market. It would be approved.

FDA approval, of course, hinges upon the conduct and database from a proper Phase 3 study, to begin later this year.