Friday, December 09, 2022 12:38:57 PM
This is a very far-fetched scenario, pure fantasy I would say. Especially, since when discussing the next steps, they did not mention once that the possibility that a 50mg subgroup analysis could lead to better outcomes.
I do not think anyone here believes anymore that the ADL mean change was significant. Especially, since there is a high likelihood that even the Cog and CDR-SB changes to not be significant under a standard two-tailed test.
Again, I disagree here. We know FDA's preference for large multiple trials when it comes to AD. They requested data from an around 2,000-patient cohort from SAVA. Given the dropout data, the patients that achieved the 50mg dosing could be 130 or less.
While releasing two out of three original endpoints is not cherry-picking...
In a nutshell, my opinion is that it is almost certain that 2-73 is superior to Lecanemab in terms of safety and likely more efficacious in terms of cognition. These findings warrant a new larger trial with a single 50mg dose given before sleep and a single primary cognition-focused endpoint. Dosing before sleep could also positively impact the ADAS-ADL metric due to the relation of dizziness and confusion to function. Such a trial unfortunately would take several years to complete but it has very good prospects in terms of eventually leading to approval, especially if it is also supported by a SPA.
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