Replies to post #781273 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Yes , meeting happened . That doesn't guarantee that meeting ended in approval . That's the part you just plainly ignore . 

[manibiotech]

Here again from GPT5 , verbatim . So tell us with link to some concrete evidence what you find as not to be a reasonable interpretation .

“ Short answer: Yes—MHRA often cites FOIA §22(1) for CHM material while a marketing authorisation application (MAA) is still being worked on, but it isn’t a signal that approval is “pending.” Legally, §22(1) is about planned future publication, not the likely outcome of the application. The MHRA routinely publishes CHM summary minutes after the relevant business concludes, so it withholds drafts/working minutes until that scheduled publication. ? ? ? 

What §22(1) actually requires 
• Settled intention to publish existed at the time of the request (the date needn’t be fixed). ? ? 
• Public-interest test: even if §22(1) applies, MHRA must weigh the public interest in disclosure versus withholding. ? ? 
• Timing can depend on other actions/events (e.g., finishing a review or finalising minutes/redactions). ? 

Other exemptions MHRA commonly uses around MAAs-in-review 

Depending on what you asked for, MHRA may rely on these instead of (or as well as) §22: 
• §41 – Information provided in confidence (e.g., CTD data, RFIs and responses between MHRA and the company). Absolute exemption. ? ? 
• §43 – Commercial interests (protects trade secrets/competitively sensitive details). Qualified exemption. ? ? 
• §44 – Prohibition on disclosure under another law (e.g., restrictions in the Human Medicines Regulations 2012 on disclosing certain information obtained in the exercise of regulatory functions). Absolute exemption. ? ? 
• §35 – Formulation of government policy (used when the material relates to policy development rather than a specific application). Qualified exemption. ? ? ? 
• §36 – Effective conduct of public affairs (where disclosure would inhibit free and frank advice/discussion). Qualified exemption. ? 
• §38 – Health and safety (if disclosure could endanger individuals). Qualified exemption. ? 
• §40 – Personal data (names/contact details, clinical narratives that could identify people). Some parts absolute, others qualified depending on context. ? ? 

Practical tips when you see §22(1) 
• Ask MHRA for the planned publication route/date (since §22 requires an intention to publish). ? 
• Request partial disclosure of any content not scheduled for publication, or ask for the public-interest test reasoning. ? 

Bottom line: §22(1) is common for CHM minutes during an active review because they’re slated for later publication, but it does not imply anything about whether the MAA will be approved. Other exemptions—especially §§41, 43 and 44—are frequently used for the scientific/commercial parts of ongoing authorisations.”

[AllSheWrote]

If I were a communications strategist for a big pharma and part of my job was to do as much damage to NWBO as possible, one tactic I might employ would be to create a fantasy bot that goes under the guise of doctor and have it post utterly insane nonsense all day long about NWBO getting approved. I mean, like laughably false and speculative nonsense that relies heavily on AI-generated misinformation. Over time, it could be a very effective strategy.

[exwannabe]

“Fully engaged can mean anything” ignores the actual rules. Section 22(1) is only used when CHM minutes already exist and are queued for publication — that means the meeting happened and the record is in the release pipeline

Yes. The meeting happened and the summary will be published sometime. And they will answer the asked question, "Was a brain cancer drug discussed". That answer will be either yes or no.

NICE’s own PMG24 requires the final SmPC before it will accept a submission, so “not yet in a position” signals the label isn’t finalised

The NICE document states clearly only the draft SmPC is needed in the evidence submission. Anybody can open this and search for SmPC. The reason for a draft version being allowed is so companies can submit early allowing for a NICE opinion within a few months of MHRA action, as opposed to a year later.

[Slave1]

Section 22(1) is not a vague “could mean anything” clause. MHRA can only apply it when the information already exists, has gone through a formal process like a CHM meeting, and is queued for publication. If this was still in scientific back-and-forth, they’d have used other exemptions like §41 (confidentiality), §43 (commercial sensitivity), or §44 (legal prohibition). The fact §22(1) was used here means the meeting happened, the minutes are written, and they’re scheduled for release.


The July 15 NICE letter isn’t idle wording either. NICE’s PMG24 is clear: they cannot complete appraisal until the final SmPC is available. “Not yet in a position to provide their evidence submission” means exactly that the final label isn’t issued yet, and label finalisation only happens after MHRA has already made its internal approval decision.


So when you put the FOI and NICE statements together, you get the standard endgame sequence: CHM review complete, label finalisation, public licence, NICE appraisal. No deficiencies, no stall, just the quiet, closed-door step before approval.


The rest of this is classic paid-shill misdirection: bury the thread in every FOIA exemption under the sun to muddy §22(1)’s meaning, pretend NICE’s wording has no procedural context, and throw in personal smears (“fantasy bot doctor”) to shift attention off the facts. It’s the same tactic every time, flood with irrelevant noise, attack the messenger, and hope readers forget the simple regulatory reality in front of them.

[Investor082]

No excuses when August comes and goes and there is no approval, OK?