Thanks Smitty. Your comment is fair, and I understand the confusion.
The key difference comes down to where NICE fits into the regulatory sequence and what they are allowed to say publicly based on timing. The RFI stage is informal and non-binding. No formal application has been submitted yet at that point. So if NWBO were still in that stage on July 15, NICE would have said something neutral like “no application has been received” or “no submission has yet been filed.” Instead, they said they had “not received the evidence submission from the company at this time.” That phrasing only makes sense if they expect that evidence to follow from a formal MHRA marketing authorization. Otherwise, they wouldn’t use the word “submission” at all.
To be clear, the wording would not be allowed in the RFI phase because nothing has officially been proposed for NICE to evaluate. Once MHRA makes a determination, NICE begins their own health technology assessment, and the company submits a separate dossier for that purpose. Until that happens, NICE cannot proceed. But the specificity of the July 15 letter shows that they are no longer waiting for a decision, they are waiting for a formal SmPC to complete the file.
The fact that we’re even discussing labeling is the giveaway. Labeling happens after the review is complete. It is not a prerequisite for submission. It is the final negotiation before public release.
So no, they could not have written the same thing in the RFI stage. That language belongs to a different phase of the process. It assumes a decision has been made, and all that remains is the delivery of final materials. That is exactly what we are seeing now.
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