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crescentmotor

08/04/25 5:45 PM

#496220 RE: BAR123 #496218

Is the clock stop actually needed?



Perhaps not theoretically, but from a practical viewpoint one can expect that it will happen as provided for in the official European regulatory timeline guidance.
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ignatiusrielly35

08/04/25 6:03 PM

#496221 RE: BAR123 #496218

The EMA is a government agency. I would bet they would pose questions, at the very least, simply to give them more time, i.e. to extend the 210 day deadline.
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LakeshoreLeo1953

08/04/25 6:53 PM

#496228 RE: BAR123 #496218

AI Captain obvious response, Thanks
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sab63090

08/05/25 5:36 AM

#496246 RE: BAR123 #496218

BAR123

I agree with you! If the EMA sees that there is no need for a "Clock Stop" at all then they should announce it!

Why the mystery and ability to delay? Protocol?......what a sloppy way to do business.