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Re: LakeshoreLeo1953 post# 480017

Monday, 01/13/2025 2:19:05 PM

Monday, January 13, 2025 2:19:05 PM

Post# of 515496
It appears that a P3 with the EMA may be different than a P3 with the FDA.

The EMA P3 could be similar to the P3 required by the FDA for an AA approval i.e. conditional approval that allows the drug to be marketed while the P3 is being run.

Perhaps that is what was being referenced in the PR.

Nunc est Bibendum

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