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exwannabe

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exwannabe

Re: FeMike post# 674794

Monday, 02/26/2024 4:37:13 PM

Monday, February 26, 2024 4:37:13 PM

Post# of 700268

Yes, Dave said that they would PR acceptance. However, it has since been pretty heavily researched and confirmed that companies very rarely PR the acceptance/validation of an MAA.


There are only a few companies that submitted MAA's to the MHRA without just being EMA Reliance based. What is the point of going to UK before EU when EU is much larger and gets UK almost for free? The only example that has been mentioned is Vertex/CRSPR with their scicke cell treatment And for that they PR the MHRA validation.

We do see PRs on FDA and EMA acceptance very common for significant drugs.
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