NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

Exkitteryff, You are basically correct.

The NICE email response to Flipper of “However, we understand that the company are not yet in a position to provide their evidence submission with us,” just means NWBO is waiting for issuance of a Marketing Authorisation (MA) by the MHRA.

The FUDsters just want to make this into something it is not. Official approval is a prerequisite. NICE can begin some pre-appraisal activities before MA, but their full evidence submission and final guidance is fundamentally tied to the product having an MA. I am not an expert in this but this is from the NICE website:

What this means
The applicant makes an application to the MHRA for a GB [Great Britain] 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 guidance.

https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/technology-appraisal-guidance/uk-licensing-and-technology-appraisals