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Thursday, 09/29/2022 6:45:39 PM

Thursday, September 29, 2022 6:45:39 PM

Post# of 461879
I'm confused about this trial report. The only thing I can find on Clinicaltrials.gov says this trial will finish in 2025. It does have the name Clarity for the trial which matches the PR trial name.

https://clinicaltrials.gov/ct2/show/NCT03887455

From the PR ...

Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai’s FY2022, which ends March 31, 2023.



From Eisai website...

In June, 2021, lecanemab was granted Breakthrough Therapy designation, which is an FDA program intended to expedite the development and review of medicines for serious or life threatening conditions. Eisai has an agreement with the FDA to submit the BLA for lecanemab as a rolling submission.


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