If you’re right, there would have to be a rule saying that all pending MAAs were automatically converted into the 2025 National Assessment Procedure as of January 1, 2025. There isn’t.
There would also have to be MHRA guidance stating that the 2025 procedure applies retroactively to applications received before April 3, 2025. The guidance says the opposite.
A procedural conversion would need to have occurred, such as a withdrawal and resubmission or a formal reassignment of the assessment clock. That kind of change would leave a record. There isn’t one.
CHM documentation would reflect the 2025 process, such as an Advice Letter, a 28-day response window, or reset milestones tied to the new framework. None of those appear.
NWBO’s disclosures would align with a reset or restarted timeline, because that would be material. They don’t. At the ASM, management described ongoing cycles of questions, clarifications, inspections, and data requests, and explicitly said they cannot predict timing. That posture is consistent with a continuing pre-2025 assessment, not a converted 2025 procedure with defined clocks.
There would also be clear consequences for approval timing. A conversion into the 2025 procedure would reset or materially alter the decision clock, delay finalisation, and introduce new, visible milestones. Instead, what we see is continued progression toward manufacturing and launch readiness, not a restart.
Finally, there would need to be a legal rule stating that issuing an MIA under the 2025 manufacturing framework compels reassessment of the clinical dossier under a new procedure. No such rule exists.
Because none of these conditions are met, the conclusion that the MAA was forcibly migrated into the 2025 assessment pathway is not supported by statute, guidance, or the public record.
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