Mike, I appreciate the pushback, and I’m not denying that this isn’t confusing. It absolutely is. These regulatory terms sound interchangeable when they’re not, and the language is built for agencies, not for investors or the public. So let’s walk through this slowly, without assuming anyone already knows the difference between a draft and a final SmPC, or why labeling matters.
What is the SmPC?
The Summary of Product Characteristics (or SmPC) is the formal regulatory label of a medicine.
It tells you:
• Who the drug is for
• How it is administered
• How often it is used
• What claims can legally be made
• What risks and warnings must be listed
• What conditions of use apply
This is not a press release. It is not a brochure. It is the central document that defines what the therapy is in the eyes of regulators, clinicians, payers, and reimbursement authorities. NICE cannot model benefit or cost until that label is finalized and approved. The SmPC is what the health system uses to define value.
What Does PMG24 Say?
PMG24 is the official NICE submission manual. In Appendix A, it says:
“Include the (draft) SmPC…”
This line is real (Yes, I double checked) and it is where most people understandably get misled. It sounds like NICE allows submission even if the SmPC is not final. But that is not what it means in practice.
The word “draft” here does not mean speculative. It refers to formatting, the fact that the SmPC might still be in regulatory layout or final typography at the time of submission. But the content of that SmPC must already reflect what the MHRA has agreed to approve.
If the MHRA has not signed off on the label, NICE does not proceed. Why? Because NICE’s appraisal process is built around the exact terms of the label. Modeling cannot begin until the regulator has formally defined:
• The population
• The dosing
• The indication
• The risks
• The benefit claims
PMG24 allows for a draft version only when the approval is done and the text is functionally finalized. If the label is still being negotiated, NICE cannot use it. Appraisal is not triggered by a guess.
What Did NICE Actually Say?
In the July 15, 2025 letter, NICE said:
“Northwest Biotherapeutics is not yet in a position to submit their evidence package.”
Let that sink in.
They did not say:
• Submission received
• Under evaluation
• Pending pricing negotiation
They said:
“Not yet in a position to submit.”
This phrase is procedural. It is not casual language. It means one thing: the materials NICE needs to begin their modeling (especially the final SmPC) do not exist yet in an approvable, regulator-approved form.
So even if NWBO has a draft internally, they are not authorized to use it. NICE cannot begin work until MHRA says the label is final.
And that only happens in one phase.
Labeling.
What Is Labeling and Why Is It Happening Now?
Labeling is the last step in the regulatory review process. It is not about science anymore. It is about language, specifically, the legal wording of the label.
Here is what the standard sequence looks like:
1. Company submits the MAA
2. MHRA performs validation
3. Clinical and manufacturing modules are reviewed
4. If MHRA concludes the product is approvable, they notify the sponsor
5. Then the two parties negotiate the final SmPC
6. Once finalized, it becomes the legal label of the drug
Only after this final SmPC is agreed upon can the company submit their evidence package to NICE.
That is where NWBO is now. They are past scientific review. They are not stalled. They are working with MHRA to finalize the wording of the SmPC.
This phase is standard. It is procedural. And it is silent, not because something is wrong, but because this is the moment before formal approval is issued.
So What Does This Really Mean?
• PMG24 allows inclusion of a draft SmPC only if the final language has already been agreed
• NICE cannot begin formal appraisal until the finalized label is in hand
• The July 15 letter makes clear the company cannot submit yet
• That means the label is still being finalized
• That confirms NWBO is currently in labeling
There is no contradiction here. No mixed message. No ambiguity once the structure is understood.
This is the final administrative bridge between internal MHRA approval and public confirmation.
Final Takeaway
The draft SmPC clause in PMG24 is not a loophole. It is not an invitation to submit early. It is a formatting provision for companies whose label has already been approved and is in final layout.
What NICE needs in order to proceed is not a draft. It is the final, regulator-approved label. The SmPC is the core of the evidence package. It defines the product that will be modeled, priced, and reimbursed.
NICE’s own words confirm the current status. NWBO is not yet in a position to submit. That can only mean one thing. The label is still being finalized.
And once it is finalized, the submission proceeds. The modeling begins. And the silence ends.
Clarification Note
An earlier version of this response referenced a seven-month review timeline. That was incorrect. The correct timeline is 19 months. NWBO submitted its MAA in December 2023, and the NICE letter was issued in July 2025. That does not change the interpretation. It strengthens it. Because after 19 months, if the company were still in review or had failed to meet regulatory standards, NICE would not be describing them as still fully engaged.
That language only makes sense if the scientific review is complete and the label is the only remaining step.
That step is called labeling. And that is where the system stands now.
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