Anavex Life Sciences Corp (AVXL)

[end2war]

The possible approval just moved at least 3 years away. Then keep on debating how A2-73 is better - it won’t mean nothing

I respectly submit that your argument is absurb, insofar as you contend that evidence that A-273 is better than Lecanemab will "mean nothing." Least you forget, Lecanemab is already approved!! If A-273 is better than Lecanemab, it will mean quite a lot; and we already know it is safer.

During the Obama administration, Congress passed the legislation to create the National Alzheimer’s Project within the Department of Health and Human Services. This legislation is intended to create a National Plan to fight AD in a coordinated manner.

At the time the NYT reported, "“What really makes this so powerful is that it takes us from a lot of small efforts going on locally to doing something in a coordinated way,” said Dr. Kenneth Kosik, a neuroscientist at the University of California, Santa Barbara. “If there’s one thing we know in science it is that to draw conclusions we need numbers, large-size populations to study.”

https://www.nytimes.com/2010/12/16/us/politics/16alzheimer.html

The recent efforts by the FDA to approve amyloid placque clearing drugs without strong efficacy or safety trials is part of an effort to study these drugs more completely and to work out a national solution.

It is important to understand they are approving drugs, not based on efficacy, but rather on the basis that the FDA thinks it wise to study the drugs in action. What many here have already said is obviously true, the recent decisions have lowered the bar on what it will take to get a drug approved.

Based on the TLR of AVXL on their P2b/3 trial results, and especially the comparisons that Missling has already draw to Aduhelm and Lecanemab, it is clear he thinks that AVXL has a good shot at approval, His "next steps" to talk to the FDA and try to convince them to accept a pivotal filing have an excellent chance for approval if the FDA thinks SR1 activation should be allowed. They don't need as much perfection in a trial if it is persuave, but we will have to see how this works in a case where there is no surrogate biomarker to support the AA. Probably, if they approve A-273 they will require a confirmatory PH 3 trial.

But, no one will know how this gets handled until after the FDA sees the TLD and discusses it with AVXL. The time seems right to move forward in AD drugs if AVXLs trials really show what Missling has been touting they show. You might turn out to be correct, but only if the data Missling has is weak. Otherwise, IMO, he is going to pull the rabbit out of the hat, with substantial evidence that he has already claimed to have.