Replies to post #805714 on NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

Once again, 2 hour 40 min mark.
"some have major objections, are precluded from approval and are over at CHM...."

[StonkMaster]

I don't think that's true. 

[FeMike]

So looks like DCVax was discussed and CHM advised on it My understanding was that MHRA refers application to CHM if they are not comfortable approving without their advisement ?? Is that correct ?

Technically, yes.

MHRA is allowed to unilaterally approve a drug without referencing the CHM.

They are not allowed to unilaterally reject an application without referencing CHM.

That being said, in practice it isn’t as much of a sign of them being uncomfortable approving unilaterally as it is a matter of procedure for a drug like this. I don’t think this ever stood a chance of avoiding a CHM review, so it’s not a hard sign that MHRA was really considering a rejection.

[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.

[Lykiri]

That’s a common misconception, IMO
MHRA does not only refer applications to CHM when they are “uncomfortable”.
In practice, many new active substances (especially first-in-class, biologics, or novel mechanisms) are routinely considered by CHM as part of the national procedure — even when approval is straightforward.
A very recent example is depemokimab (Exdensur) for eosinophilic asthma and CRSwNP:
- Discussed at the CHM meeting in October 2025
- CHM minutes published before formal approval
- MHRA approval followed in December 2025 without controversy
So CHM involvement does not imply regulator discomfort — it often reflects scientific novelty, public health relevance, or statutory routing under UK law.

SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 30TH OCTOBER 2025

LICENSING

NEW DRUGS (not previously licensed in the United Kingdom)
The Commission considered and advised on a medicine used as an add-on treatment to
standard therapies for the maintenance treatment of eosinophilic asthma (a specific type of
asthma where the inflammation in the airways is caused by high levels of a particular white
blood cell called an eosinophil) and for treatment of chronic rhino sinusitis with nasal polyps
(a long-term medical condition where the lining of the nose and sinuses are constantly
inflamed and this inflammation leads to the formation of soft, non-cancerous growths called
polyps)

.
https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/2073365630019

Press release

UK approves the first twice yearly biological medicine for asthma and severe chronic rhinosinusitis with nasal polyps
As with any medicine, the MHRA will keep the safety and effectiveness of depemokimab under close review.

From:
Medicines and Healthcare products Regulatory Agency
Published
15 December 2025

https://www.gov.uk/government/news/uk-approves-the-first-twice-yearly-biological-medicine-for-asthma-and-severe-chronic-rhinosinusitis-with-nasal-polyps