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Re: Investor2014 post# 503378

Friday, 10/17/2025 8:54:32 AM

Friday, October 17, 2025 8:54:32 AM

Post# of 517454
I'm in the Conditional Marketing Authorization camp too versus an unburdened Full approval, and given the low "n" of the past trials, to me it seems reasonable for a regulator to request more data.

Now what will be required by the EMA for post approval studies is definitely up for debate and to me an approval is an approval and it will be exciting to see blarcamesine available in the wild nonetheless.

I think requesting another full RCT P3 is overkill.


Thanks for using links to original sources.
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