Hi Odds
This is the explanation:
https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines#:~:text=mutual%2Drecognition%20procedure%2C%20whereby%20a,in%20several%20EU%20Member%20States.
However, if a drug has been approved by the FDA, based on clinical trial data, I think it is highly likely that the EMA would evaluate the same data to make a decision. ie no need for a separate series of clinical trials. The EMA would make its own decision - but based on the same data.
Cheers
Dave
Why IMU is a multi multi bagger, page-20392
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