FeMike, you’re asking for evidence that NWBO is in the labeling phase. That evidence is right there in the language used by NICE in the July 15 response, and it aligns exactly with how the MHRA and NICE processes are structured.
When NICE says NWBO is “still fully occupied and engaged in the MAA process with the MHRA” and “not yet in a position to provide their evidence submission,” that describes the labeling phase, also known as SmPC finalisation.
Here’s the regulatory proof:
1. MHRA guidance explicitly states that once the review of an MAA concludes, the agency works with the sponsor to finalize the Summary of Product Characteristics (SmPC) which is required before the license is granted and published.
2. NICE appraisal guidance confirms they cannot begin evaluation without the SmPC or equivalent evidence.
From NICE’s official STA process guide (PMG24):
“NICE will only begin the appraisal process once a product has been granted marketing authorisation (or is expected to receive one) and the company is in a position to provide an evidence submission including the SmPC.”
This is not speculation. The process is defined. The only reason NWBO would be “fully occupied” with MHRA yet not submitting to NICE is because the SmPC is still being finalized. That is the labeling phase, and NICE’s response confirms it in plain English.
You may disagree with the interpretation, but the regulatory structure makes it clear. This is how approval is implemented. The company isn’t waiting for a decision. They’re working on how it will be published.
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