Mike, I looked carefully at your rendition of the 2018 NICE letter versus the actual July 15, 2025 letter, and they’re not “the same exact thing” not in context, not in tone, and certainly not in regulatory meaning.
The 2018 letter explicitly stated that NICE was suspending the appraisal because NWBO wasn’t able to provide an evidence submission. That reflected a full disengagement. There was no MHRA application in motion, no active review, and no SmPC even on the horizon.
The 2025 letter is categorically different. It says NWBO is still fully occupied and engaged in the MAA process with the MHRA and is not yet in a position to submit to NICE. According to NICE’s own submission manual (PMG24), that phrase refers to the window where a company is waiting for MHRA to finalize the SmPC, the legal product label, which is only issued after the internal approval decision has been made.
So no, this isn’t a seven-year labeling phase. In 2018, they hadn’t even entered the process. In 2025, they’re in the final procedural stage before public approval. That’s not theory, it’s exactly how NICE’s system works.
If we’re going to compare regulatory letters, we need to match them to the correct stage of the process. Otherwise, it’s just mixing timelines to confuse the signal.
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