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Re: 12x post# 475824

Monday, 12/02/2024 5:11:24 PM

Monday, December 02, 2024 5:11:24 PM

Post# of 517739
I think that you can count on a confirmatory trial with the EMA. That is not so bad as they have 5 years to get it completed I believe and they will be selling the drug the entire time. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-subgroups-confirmatory-clinical-trials_en.pdf
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