NorthWest Biotherapeutics Inc (NWBO)

[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.”