We need to understand why the FDA acted as it did with Biogen on their Aduhelm application, and the answer is right there in your excerpted text:
FDA reviewers and the agency’s report noted that these regular meetings between Biogen and the agency were “not typical of other development programs,” but FDA ultimately legitimized the decision by concluding that the interactions “were consistent with the agency’s public health mission given the potential for the first disease modifying drug for Alzheimer’s disease.”
Let me translate that from DC-speak into message board English: The FDA is desperate to approve a disease-modifying drug for Alzheimer's. Even after the adverse fallout from its Aduhelm decision, the FDA remains desperate.
It was the Agency's desperation that led its senior managers, who remain in their jobs, to approve an AD drug application that was so weak it not only was not disease-modifying, but convinced third party actors like the SAB, Medicare, and European regulators that it failed the primary risk/benefit test.
That degree of poor decision-making will not be repeated. However, the Anavex 2b/3 trial results, even partially known as they are today, are far superior to what the FDA approved with Aduhelm. Unless you are willing to believe Missling is out-and-out lying in the PR (which would be irrational for him, and therefore irrational for you to conclude), Anavex met its endpoints in this trial. The ADL endpoint is not at all usual, but it is certainly not an endpoint that Aduhelm could have reached or, for that matter, Lecanemab. It is an endpoint designed to show disease modification in a certain group of patients. And the FDA is still desperate to approve a disease-modifying AD drug, not to mention an easily administered and safe disease-modifying AD drug.
The use of a successful Odds Ratio endpoint will not deter the FDA from approving blarcamesine, given that such an approval will be "consistent with the agency's public health mission given the potential for the first disease modifying drug for Alzheimer's disease." Anavex is making a much smaller ask of the FDA than Biogen or Lilly or other pharmas have been making. The FDA, for its reasons, is as desperate to get this type of drug on the market as the pharmas and biotechs are for theirs.
