NorthWest Biotherapeutics Inc (NWBO): For NWBO at this time, this seems like t...

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flipper44

Re: Red_Right_Hand post# 674899

Tuesday, 02/27/2024 11:10:23 AM

Tuesday, February 27, 2024 11:10:23 AM

For NWBO at this time, this seems like the most relevant section, which goes into effect March 1, 2024.

Applications which are technically complete will continue on to scientific assessment and where there are issues raised a single request for information (RFI) will be sent out to the applicant (there will no longer be more than one RFI).

Applicants will have 60 calendar days to respond to the RFI.

There will be three outcomes from this point:

*If the response is complete the application will be determined[/color]

*If the response is inadequate on quality, safety or efficacy grounds, then the application will be referred to the Commission for Human Medicines for advice

*If no response is received within the timeline of 60 days, then the application will be refused.

https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines#established-medicines