Well said and I agree with most of what you wrote. It's likely that upon further review by Dr. Jin, one of the primary endpoints didn't perform well enough to stand on its own but it did perform well enough when considering approval from alternate pathways such as using two secondary endpoints.
I also expect that Blarcamesine will be approved. The Philadelphia Eagles have created a play called the "tush push" that opposing teams cannot stop. It involves getting several of the team's strongest players behind the quarterback and pushing him forward across the goal line. I believe the Rett Foundation and caretakers will be the driving force behind Anavex's NDA submission. Daybue is already on the market but it has its own set of issues, and the FDA will allow capitalism to decide which drug wins over the Rett community.
Once approved for Rett, it becomes easier for Alzheimer's to seek its own label because safety is taken out of the equation. Efficacy aside, Anavex has a lot going for it considering that in many parts of Europe and even some places in rural America, getting to an MRI center isn't convenient for elderly patients. In the near future the -Mab drugs will be approved for at-home injections similar to insulin, but Blarcamesine still wins on safety and convenience.
The "We Got This" crowd fails to acknowledge the grim reality that Blarcamesine is most likely a temporary placeholder. Best case scenario: Blarcamesine becomes the standard of care for several years, but eventually goes the way of Aricept when something newer and better comes along. Hopefully it's A371 -- we should be getting a name for that drug sooner or later. But there's a reason the prophylaxis trials are being done with A371 and not Blarcamesine -- this is the company tacitly saying that it sees A371 as the future, and the long-term driver of real wealth creation.
And A371 is a long ways away. But it's the one that investors should care about. I'd love to see Blarcamesine succeed. But I watched those Facebook videos. It's not a cure. Far from it. It's a crutch that will lead to an improved quality of life for millions of people until something better comes along. How much that is worth is anyone's guess but I'm willing to bet a lot of money that it's worth more than $9/share.
Lucky Numbers: 19, 7, 33, 43, 49, 1*
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