“Still fully occupied and engaged in the MAA process with MHRA” confirms only that the file is active.
It does not confirm that the application is approved in principle or that the SmPC is being finalized. That phrase applies equally during: The final review phase, Addressing minor questions, Ongoing internal discussions at MHRA. Saying deficiencies don’t exist based on NICE’s phrasing is speculative. MHRA never signals deficiencies via external agencies like NICE.
“The company are not yet in a position to provide their evidence submission”
reflects NWBO’s status, not MHRA’s. NWBO hasn’t submitted evidence to NICE. That could be: Because MHRA approval hasn’t been granted. Because NWBO hasn’t prepared the submission. Because NWBO is waiting strategically. It does not confirm that the SmPC is in finalization. NICE waits for submission after approval or expected approval. The fact they’re waiting tells you nothing about whether MHRA has granted approval internally.
“No further input being requested” is an assumption.
NICE doesn’t monitor the MAA’s procedural status they’re passive. They know nothing beyond what NWBO chooses to disclose. Saying the file is “closed to new evidence” and “the SmPC is being finalized” is pure speculation based on interpreting process guidelines, not direct evidence.
Silence ? labeling. Silence can mean: Final review without formal decision. Ongoing internal MHRA deliberation. Minor clarification rounds that don't require new data.
You take vague, process-agnostic language and interpret it as hard proof of labeling phase. It’s confident-sounding, but factually unsupported. They’re framing procedural possibility as procedural certainty. Is labeling possible? Yes. Is it confirmed? Absolutely not. You are selling interpretation as fact and the sad fact is that others believe you because they are desperate.
The real status: The file is active. MHRA hasn’t communicated approval. NICE is waiting.
Beyond that, we know nothing definitive only that you are full of it
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