NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

" (up to Day 90) " ..... LOL Keep dreaming.

Major objections are defined as serious deficiencies in quality, safety, or efficacy that, if unresolved, would preclude granting a marketing authorisation.
In the national assessment procedure, if major objections are raised (e.g., in a Request for Further Information (RFI)), the MHRA consults the CHM under Paragraph 5 of Schedule 11 to the Human Medicines Regulations. If the CHM provisionally considers it may not advise approval, the applicant receives a formal "CHM letter" outlining the reasons (typically by Day 150), pausing the assessment clock.
If the applicant's response does not resolve the issues, the MHRA refers the application to the CHM for advice on potential refusal.
Similar referrals occur in other procedures, such as the International Recognition Procedure (IRP): unresolved major objections at Day 110 lead to seeking formal CHM advice on approvability, reverting to the full 210-day national timetable.