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Slave1

08/12/25 5:41 PM

#781012 RE: Lykiri #781000

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.
Bullish
Bullish
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dennisdave

08/12/25 5:48 PM

#781014 RE: Lykiri #781000

than you Lykiri that MHRA reply is very interesting

The MHRA explicitly says:

"We can confirm that the Agency holds the information you are seeking."


This means yes, a medicine for the treatment of brain cancer was discussed in the May or June 2025 CHM meetings.
It’s essentially confirmation that DCVax-L (or another brain cancer drug, but let’s be realistic there aren’t many actually, there are not any) was on the CHM agenda in that period. This FOI reply is about as close as you’ll get to an indirect confirmation that DCVax-L hit CHM review in Q2 2025, without MHRA explicitly naming it yet.

Why an approval seems unlikely at end of June
If CHM had recommended approval in late June:
MHRA usually formalizes and notifies the sponsor within 1–2 weeks.
NWBO, as a public company, would be legally obligated to issue an 8-K within a couple of business days. We’re now well beyond that window ? no announcement ? no approval yet.

Two realistic scenarios left
1. CHM raised new questions ? another RFI
This aligns with NWBO’s own language about “continuing consultation with the MHRA.”
Would explain the gap between CHM review and any final decision.
Could be: SmPC/label narrowing
Manufacturing clarification (Flaskworks)
Evidence interpretation details

2. CHM did not recommend approval (outright or provisional)
A rejection would be market-moving, so NWBO would have to disclose quickly.
Since that hasn’t happened, this outcome is less likely unless NWBO is somehow arguing internally that the CHM outcome is not “final” yet.
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H2R

08/12/25 5:58 PM

#781017 RE: Lykiri #781000

Hello Lykiri,

I took a look at the file, it seems to be from June 2024, not this year:

THURSDAY 27TH JUNE and FRIDAY 28TH JUNE 2024
LICENSING



Same with the file name (CHM 27_28_June 2024 ....)

Best of luck to Patients, NWBO, and Longs!
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ATLnsider

08/12/25 6:14 PM

#781022 RE: Lykiri #781000

Thanks Lykiri‼️ This is great information‼️
Bullish
Bullish
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Red_Right_Hand

08/12/25 6:24 PM

#781023 RE: Lykiri #781000

On June 30, 2025, Northwest Biotherapeutics, Inc. (the “Company”) entered into transactions involving potential share issuances related to fundings totaling $3,900,000 pursuant to this prospectus supplement. The offering comprises newly registered common stock potentially totaling 17,727,273 million shares at a price per share of $0.22.

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AllSheWrote

08/12/25 7:57 PM

#781049 RE: Lykiri #781000

This is a standard boilerplate response to a FOI request in which they decline to provide the information you requested. They probably send dozens of these every month. The first sentence simply confirms they have the minutes you are requesting, as they are required to disclose by law, but that they are not going to release them because they are not ready. There is nothing you can glean from this response about the status of NWBO's application for DCVax-L. But nice try with the pump.
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H2R

08/12/25 8:10 PM

#781055 RE: Lykiri #781000

Sorry Lykiri,

I did not parse your email correctly. That tends to happen when I do a quick check at work and I read my favorite posters. I went to the link and started looking around that archive.
Cheers!

Best of luck to Patients, NWBO, and Longs!
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Mr.reveulto

08/12/25 9:49 PM

#781065 RE: Lykiri #781000

so when we’re expecting the decision?!
Bullish
Bullish
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StonkMaster

10/08/25 8:47 PM

#791738 RE: Lykiri #781000

The CHM meeting minutes are now posted up to and including August 2025.

https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/folder/3484299262

I quickly scanned May/June, and every other month, and don't see any mention of a medicine to treat brain cancer.