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LakeshoreLeo1953

08/13/25 2:59 PM

#497699 RE: Steady_T #497695

Not my point.
THE point is Clock Stop two of ONLY Marketing etc
is certainly not a given.
We will know if LoQ answers were sufficient IF there is no clock stop 2.
Beyond THAT you are likely guessing about pro forma responses prior to
a positive referral to the EMA.
I just am not prepared to claim that is the case.
At the very least (if not already asked) "how would we benefit from a confirmatory trial?"
should have been or is anticipated to be a question from CHMP.

After the Holidays and everyone (including Missling) can start anew with timelines.