NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

I have no idea what you are talking about. The November minutes reflect what they have already been doing for several months or even a year. If they have "advised" that means they were reviewing the file for a long time already. They don't take 1 day to advise on a huge MAA. Anyway, here is how it works. 👇️

CHM Referral Process: The CHM reviews the application and provides a provisional opinion. If this opinion is that the MA should not be granted, the applicant receives a CHM letter detailing the grounds. This stops the assessment clock. The applicant has 28 days to confirm if they wish to make written or oral representations to the CHM, which must then be submitted within 6 months (extendable in exceptional cases). The clock restarts upon submission, and the CHM considers these representations before issuing final advice to the MHRA.

gov.uk

If Approval is Precluded: If the CHM's final advice supports refusal (or the MHRA decides against granting based on it), the MHRA issues a formal refusal letter outlining the grounds. This only occurs after the full CHM process, unless the application is incomplete or deadlines are missed. A Public Assessment Report is published after any appeal concludes or if the applicant withdraws.