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Thursday, January 04, 2024 3:24:22 PM
It will give assurance that application is complete and valid as I don’t have much faith in company doing so . So external validation will help to boost confidence in new investors
Yes, though a very low bar so not going to be a large pop. It is really more a matter of avoiding the endless "where is the validation" that will start next week.
There is a real difference between the FDA and EMA (and I assume MHRA) in this. The EMA validation is more of a mechanical checklist that the application is complete. The FDA actually will evaluate the issue of the sponsor's claims would support approval.. The FDA can RTF (Refuse To File) even a structurally complete application. Ask Gary about IMGN 10 years ago.
There should be no possibility of serious issues with the MHRA validation as they would have been discussed at the pre-submission meetings. Barring a complete con-job by NWBO (which not even I would accuse them of), the validation will happen and it is only a matter of a few days or maybe a couple more weeks.
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