NorthWest Biotherapeutics Inc (NWBO)

[theorysuit]

IFor MHRA approval, the Commission on Human Medicines (CHM) is a crucial independent advisory body that provides expert advice on medicine safety, quality, and efficacy, especially for innovative medicines (new active substances, biologics, orphans, etc.) or complex cases, often involving a formal consultation process that can extend timelines. While some fast-track routes exist (like International Recognition Procedure for EU/US approvals), the CHM's input is vital for complex or high-risk applications, influencing final MHRA decisions, and you'll interact with them if major concerns arise during review.
When CHM Involvement is Likely:
Innovative Medicines: Applications for new active substances, biologics, vaccines, biosimilars, new combinations, or orphan drugs.
Complex Cases: When the MHRA needs expert input on safety, quality, or efficacy.
Major Objections: If significant issues arise during assessment, the MHRA might consult the CHM, potentially triggering a pause in the clock and a chance for the applicant to present to the CHM.
International Recognition Procedure (IRP) Route B: Products approved under specific conditions (like orphan status, conditional approvals) may involve CHM consultation.
CHM's Role:
Advisory: Provides independent advice to the MHRA on granting marketing authorization.
Review: Considers complex applications or specific issues raised by the MHRA.
Hearings: May hold oral hearings for applicants to present their case.
How it Affects You:


What might they be concerned about? The trial and the gymnastics played on it? That is a big red flag.