The spectre of the prophylactic AD trial will have, as a secondary effect, a significant impact on the decision making process of the FDA (force their hand, if you will) when presented with the results from the 2B/3 AD trial.
When the cards are laid out on the table, so to speak, the FDA will be facing the following scenario:
1) A novel therapy candidate has achieved what no prior therapy has for current AZ sufferers, both from a statistical/clinical data standpoint, as well as from years of RWE. Not to mention the pristine safety profile and the general applicability of the drug towards stabilizing a multitude of health problems (ie insomnia, heart disease, plus any yet-to-be-discovered conditions).
2) The previously and controversially approved therapy (Aduhelm) despite its now 1+ year availability, has virtually no active patients nor any RWE supportive of its "efficacy".
3) "Normal" healthy people, be they genetically predisposed or otherwise inclined to proactively manage their odds against developing the most devastating of disease outcomes, suddenly, upon hearing about the increased media coverage of Blarcasemine, have "skin in the game" in this upcoming FDA decision, as it will implicitly impact their own ability in the future to access Blarcasemine.
Given this scenario, a potential FDA rejection of Blarcasemine is now a virtual impossibility - given the history of point 2 as well as the unprecedented visibility of the decision on the eyes of the world... not the minority of the population who are current AZ sufferers, but of the (presently) healthy majority.
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