NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Manibiotech,

That’s a fair question, but here’s the key distinction:

If NWBO were still in the RFI (Request for Information) stage, NICE wouldn’t have used that specific language in the July letter. The RFI stage is pre-submission, NICE doesn’t yet discuss the absence of evidence at that level. But the July 15 letter explicitly states that “NICE has not received the evidence submission from the company at this time.”

That phrasing only appears after a company becomes eligible to submit. And per NICE’s PMG24 Submission Manual (Dec 2024), a company cannot submit unless they have at least a draft SmPC (Summary of Product Characteristics).

So the absence of submission at this point tells us three things:
• NWBO has moved beyond the RFI stage
• NICE is awaiting evidence, meaning submission is now procedurally allowed
• NWBO is still finalizing the SmPC with MHRA, and labeling is the gating item

That’s why the cleanest read, based on both the letter and the PMG24 rules, is that NWBO is currently in the labeling phase. Once MHRA finalizes the draft label, NICE submission becomes possible.