NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Lykiri, thank you for sharing this FOI response. It’s an important piece of the puzzle, and it’s worth walking through exactly what it tells us and how it fits with the MHRA’s process.

1. CHM’s role at this stage

• The Commission on Human Medicines (CHM) is the independent expert body that MHRA uses for advice before granting or refusing a marketing authorisation.
• Late in the process, when a product like DCVax-L comes before CHM, the discussion is focused on the draft Summary of Product Characteristics (SmPC), the legal “label” that defines the indication, patient population, dosing, safety warnings, and any conditions of use.
• CHM’s advice at this point is one of the very last inputs before MHRA finalises the label and issues a decision.

2. What the FOI reply confirms

• MHRA has explicitly confirmed that a brain cancer medicine was discussed at the May or June 2025 CHM meeting.
• They are withholding the content under Section 22(1) of the Freedom of Information Act, which is used when the information is already scheduled for official publication at a future date.
• In this case, that means the details will appear in the official CHM Summary Minutes once those minutes clear the publication process.

3. Why the delay is normal

• CHM minutes aren’t posted the day after the meeting, they go through accuracy checks, redactions for commercial confidentiality, and formal MHRA approval before release.
• This can easily take three months or more. If the meeting was in May or June, August 12 is still well inside the normal publication window.
• The MHRA’s own website and prior CHM cycles show similar delays, so this is standard procedure.

4. Why this fits the labeling/finalisation stage

• Being on the CHM agenda now means the scientific review is essentially complete, the focus is on label wording, indication scope, and any specific requirements attached to approval.
• These elements are commercially sensitive and regulatorily confidential until the decision is public, which is why MHRA won’t release them ahead of the official minutes.
• The fact they’ve acknowledged the discussion but are withholding the details strongly suggests we are in the labeling/finalisation phase, with everything locked down until the formal record is ready.

My take: This FOI response is not just routine, it’s a direct signal that DCVax-L has reached one of the last formal steps in the MHRA’s process. CHM has already met, the advice is in MHRA’s hands, and the minutes will document it once they’ve gone through the usual accuracy and clearance stages. August 12 silence fits perfectly with that scenario.

And again, thank you, Lykiri, for sharing this personal response. It’s exactly the kind of document that, when placed in context, shows why we’re seeing what we’re seeing right now.