Anavex Life Sciences Corp (AVXL)

[Joseph_K]

If blarcamesine is approved it will be more successful than lecanemab ...

I just wanted to highlight Doc328 saying this. I think it may have slipped by somewhat unnoticed. He's not a fountain of positive blarcamesine comments.

Granted that's not the whole sentence, which is

If blarcamesine is approved it will be more successful than lecanemab but Missling needs to get it across the finish line and then make up for a 4 year lag.

I don't agree with the "4 year lag" part. It could be 4 years, but if the evidence on biomarkers or efficacy is good enough, there should be a lot less lag time than 4 years under AA.

I also think that some of the reasons blarcamesine would be more successful than lecanemab are also reasons blarcamesine has an even better chance of AA approval, reasons the FDA will choose to "grade" Anavex's AA NDA very generously.

The obvious one is the relative safety profiles of blarcamesine and the mabs, which will be the only other treatment option at the time of the application review. I don't know if cost is something the FDA is allowed to consider, but, if it is, that would be another reason inclining the FDA to grade blarcamesine generously on efficacy and biomarker evidence.

While I don't know if cost is something the FDA takes into account, I'm quite sure that another of the reasons blarcamesine would be more successful than lecanemab -- the ease of administration -- is a reason the FDA will very much want to grade blarcamesine generously. The fact that it's a pill isn't just more convenient in the way a dishwasher soap pod is more convenient than a bottle of dishwasher soap. The pill aspect opens up rural America to treatment for Alzheimer's, an area that the government is concerned about being left behind on medical progress and for which it makes special efforts, such as a program to increase rural participation in clinical trial development and incentives for doctors to locate in rural areas. The mabs dependence on MRIs and infusions excludes people in large swaths of the country from using them; if the FDA can see even arguable benefit from blarcamesine on efficacy and surrogate biomarkers, I believe it will put its thumb on the scale to help serve rural Alzheimer's sufferers.

These reasons I've stated for the FDA grading a blarcamesine NDA generously I assume would apply to other countries' drug regulators, too.