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exwannabe

02/26/24 4:37 PM

#674801 RE: FeMike #674794

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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RobotDroid

02/26/24 6:27 PM

#674817 RE: FeMike #674794

You said almost. And DI, as a rep of nwbo, should not be ass talking. It all does not add up. The missing piece is a failed submission. Now they may have fixed it and re applied, but that still says a lot about not being truthful to the SH. That is very very wrong, and speaks of despiration and subtrafuge. But most want to keep the blind faith blinders on and make believe everything is alright. It ain't.