Anavex Life Sciences Corp (AVXL)

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But, will the thunder be Down Under?

The FDA is a complex beast which can do good and sometimes makes mistakes.

Understandably, we are focused on attaining FDA (US Food and Drug Administration) approval of blarcamesine, as an allowed therapeutic for any of the now four CNS disease for which there is strongly supportive data (Rett syndrome, Parkinson’s disease dementia, Alzheimer’s disease, and fragile X syndrome).

What happens, however, if the Australian Therapeutic Goods Administration (TGA) first grants approval of blarcamesine, for any of these CNS conditions? As I’ve previously and frequently contended, the public’s perception of blarcamesine will be profoundly shaped and prompted not by clinical trial results, but rather by news articles about the drug consequent to those studies. When the New York Times prints an article stating that blarcamesine works, there are no more questions.

But what if the TGA approves blarcamesine while the FDA is still slowly cogitating on the matter? What happens when reports from Down Under reveal patients with any of the targeted CNS conditions begin to live normal lives; without side effects? Will the FDA claim that “We still need more clinical data?”

Of course, the FDA approved Aduhelm, lacking both good clinical results outcomes, and the recommendation of their critical review board.

Things are going to get very interesting, even curious, if the TGA acts first. Could very well happen.