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Re: georgejjl post# 365259

Wednesday, 07/06/2022 6:41:57 AM

Wednesday, July 06, 2022 6:41:57 AM

Post# of 518895
Interesting - the trial results are still not out

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early AD is ongoing and enrollment of 1,795 patients was completed in March 2021. The readout of the primary endpoint data from the trial will occur in the Fall of 2022.

The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Eisai utilized the FDA's Accelerated Approval Pathway in an effort to streamline the submission process for the potential traditional approval of lecanemab….
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