FeMike, the reason this means something different now than it might have a year ago is because of timing, sequence, and the structure of the MHRA review process. This is not about reinterpreting the same words arbitrarily. It is about what those words mean at this specific point in the review.
Let’s look again at the exact phrasing NICE used on July 15, 2025:
“NWBO reports that it is still fully occupied and engaged in the Marketing Authorisation Application (MAA) process with the MHRA”
“The company are not yet in a position to provide their evidence submission with us”
“We await further contact from them”
You asked why this same language could not describe the company’s state a year ago. It could have, but it would have reflected an earlier part of the process. That is how structured regulatory systems work. The MAA process is sequential. What comes before submission is not the same as what comes after review.
MHRA marketing authorisation follows a defined order 1. Pre-submission 2. Validation 3. Review and clock phases 4. End of procedure 5. Label finalisation (SmPC) 6. Marketing authorisation granted 7. NICE engagement
The July 15 letter confirms that NWBO is still within the MAA process and has not submitted their evidence to NICE. But NICE also says they await further contact. That means they are waiting for NWBO to finish work with MHRA before NICE can proceed. At this point in the timeline, the only work that remains is the finalisation of the Summary of Product Characteristics, or SmPC. That is labeling.
Why? Because NICE cannot appraise a product until the company submits either a draft or final SmPC along with its evidence package. This is a published requirement in NICE’s STA process guide.
Quote “The company should submit evidence including the final or draft Summary of Product Characteristics”
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