News Focus
News Focus
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Lykiri

05/04/25 3:32 PM

#765835 RE: beartrap12 #765832

MHRA guidance says they have to publish a press release within a week after approving a new active substance. I expect NWBio will choose their own moment to announce the MHRA’s decision.

Following authorisation of a NAS, we will publish a press release within one week


https://www.gov.uk/guidance/national-assessment-procedure-for-medicines
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froggmister

05/04/25 3:42 PM

#765838 RE: beartrap12 #765832

I'm curious which hour of the day they will announce the MHRA decision



One possible interesting comp on this is when Vertex went to the MHRA for the first regulatory authorization of a CRISPR-based gene-editing therapy in the world, Casgevy. It was approved on Nov. 16, 2023 and Vertex released the news at 7AM EST, noon GMT.
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KevGee59

05/04/25 6:28 PM

#765849 RE: beartrap12 #765832

Wouldn't we know as soon as the MHRA decision was posted to their website? Regardless of if NWBO decided to announce it then or not.