Replies to post #805712 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Thanks Lyriki
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 ? Or all new de rug MAA have to go through CHM ?

[AllSheWrote]

At the ASM, the CEO said she had no idea where the process stood or how long it would take,

[StonkMaster]

Thanks Lykiri, great find. Any day now.

[FeMike]

Certainly interesting and a good find.

Curious if Nemesis wants to chime in on this since the application was pulled and is being investigated for fraud which is certainly not the job of the CHM.

[beartrap12]

Lykiri, This is a big deal! Thanks for finding this out about the CHM meeting that is almost certainly DCVax-L:

SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 27TH AND FRIDAY 28TH NOVEMBER 2025

LICENSING
NEW DRUGS (not previously licensed in the United Kingdom)

The Commission considered and advised on an application for a marketing authorisation for
a medicinal product used to treat glioblastoma (a cancer of the brain).

A month later and the company is moving full steam ahead on expansions in the US and Sawston and plans for clinical trials; hospitals and doctors are clamoring to be a part of NWBO plans and they've already determined how management will be expanded...by hiring consultants.
Sounds like we're very much still in the game and heading for approval. Certainly there's a deadline for sharing bad news and I'm sure it's not a month out.
Hang in there, Longs!

[ATLnsider]

Thanks for posting Lykiri‼️

[TheFollower]

Lyriki, thanks so much.
We should be seeing the December minutes shortly, too, correct?

[FeMike]

With any luck, maybe this 'news' will create some desperately needed FOMO heading into the new year.

[flipper44]

Interesting, my initial recent guess was right, the November 28, 2025 date (not the December 19, 2025 backup). It’s interesting. Artificial intelligence is still placing January 31 as a likely grant date (if the CHM did a (hypothetical) approval recommendation WITH CONDITIONS to be met in 28 days by sponsor) because of the intervening mia certifications and holidays, and the two to three weeks it takes for the regulator to conduct final compliance checks.

Due to the internal grant calendar.

However, it thought LP would have to have been far more cynical on December 29 to tell retail she had “no idea” how long things might take.

However, It still believes, like I do, the c level cleanroom construction initiation starting at the end of January is likely the key tell.


Here’s how artificial intelligence explains the situation if the CHM recommended approval if certain conditions are met within 28 days.

The "fudge" isn't in the math; it's in the administrative reality of the UK regulator. They batch these final grants. If you miss the December cycle (which NWBO clearly would have), the next available slot for a major new license is the end of January.

She didn't move the construction to the end of January by accident—she moved it to match the MHRA's internal 'Grant' calendar.

[attilathehunt]

Great! Thank you for sharing!

Do you know when the report was published (first made available)?

If after ASM, then LP stating not knowing where we are at could be accurate.

[tunnelvisionofplenty]

Nice, you beat me to it :)

For the most part, for drugs that had a second CHM meeting and then got approved, approval came within about 3 weeks at the earliest and about 3 months at the latest.