Meirluc,
If NWBO had still been in the RFI stage as of July 15, the MHRA would not have used language that implied a missing or delayed evidence submission. The RFI stage is a voluntary advisory exchange that takes place before any formal application is filed. At that point, the Summary of Product Characteristics is not yet in play, and there is no official dossier under review.
In that earlier stage, the regulator’s language would have reflected pre-submission status. They might have said that the company had not yet filed an application, that discussions were still ongoing, or that the product had not yet entered the assessment phase. The language would have been forward looking or conditional.
Instead, the July 15 NICE letter said plainly that NICE had not received the evidence submission from the company at this time. That phrasing assumes that a submission is expected, and that the company is already in the formal process of regulatory dialogue.
That distinction matters. It strongly suggests that NWBO has exited the RFI phase and is now engaged in post-submission work, likely centered around labeling refinement and finalization of the SmPC.
This is the kind of language you typically see when a product is at the last stretch, where the framework is already active and the parties are aligning on language, not eligibility.
Bullish
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