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Thursday, October 24, 2024 9:44:46 PM
NICE says "We aim to publish final guidance for all new technologies within 90 days of receiving marketing authorisation." But LP says she's still in the early stages of getting material to NICE. STEP 1 and step 2 are all really one step. 2 should really come before 1. Shareholders deserve to be briefed. She's stalling, IMO.
What this means
The applicant makes an application to the MHRA for a GB marketing authorisation through either the IRP or national licensing route.
- Arrangements and timing of company submissions to NICE are decided based on expected MA date, unless a delay to submission is requested and agreed.
- Prior to issuing final guidance, NICE will ensure that the MHRA has issued a GB marketing authorisation.
- In circumstances where there is a delay to the GB marketing authorisation, NICE will delay publication of final guida
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