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Hosai

06/25/24 7:20 AM

#462362 RE: Investor2014 #462359

Where does one find the stats on clock stop 1? Would be interested in what % of all apps are withdrawn at this point.
Overall approval rate when you take out withdrawals is very high - 96.25% (77 approved, 3 rejected in 2023).
19 were withdrawn though so for 2023 around 78% of all submitted apps to EMA were approved.
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WilliamMunny

06/25/24 9:38 AM

#462372 RE: Investor2014 #462359

I rather think that since LEQEMBI passed clock-stop 1, Blarcamesine has an extremely good chance of doing the same.
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frrol

06/25/24 12:44 PM

#462416 RE: Investor2014 #462359

The EMA's Validation step (Day 0, takes about 2 weeks from submission, and is when the process clock really begins) and the first LOQ (Day 90 after Validation) are two important hurdles. I don't think it's common for a company to say they passed Validation, nor for them to say they finished responding to the first LoQ. (A timetable of the EMA's expectation date to receive the response is published, by the EMA.)