You’re mixing together early engagement with formal appraisal, and then drawing conclusions that don’t actually follow from NICE’s own process.
A few clarifications, based on how NICE actually operates:
1. Yes — NICE can begin preparatory work before regulatory approval.That includes early scientific advice and allowing companies to submit evidence in advance so NICE can prepare. NICE often encourages submissions several months before approval for planning purposes.
2. But that is not a completed appraisal, draft recommendation, or reimbursement decision.Even if evidence is submitted early, NICE cannot finalize:
• the appraisal committee recommendation
• cost-effectiveness conclusions
• routine commissioning status until the product is licensed by MHRA and the final approved indication and label are fixed.
In other words: early submission, approval and reimbursement secured.
3. A “draft opinion” before approval is conditional and non-binding.Any draft prepared pre-approval is explicitly contingent on:
• final MHRA outcome
• approved population
• comparator set
• pricing and access scheme assumptions
If those change (which often happens with first-in-class or novel therapies), NICE work must be revisited.
4. The claim that “NWBO has not submitted evidence” is not publicly verifiable. 5. NICE does not publish:
• when a company submits evidence • whether submissions are partial or complete
• whether data are under confidentiality
Public NICE language such as “liaising with the company” or “in discussion” is entirely consistent with:
• early engagement
• preparatory dialogue
• confidential evidence review
It does not imply inactivity, delay, or misconduct.
5. Hiring consultants does not mean a public submission clock starts.
6. Companies routinely:
• retain NICE/HTA consultants
• iterate evidence packages
• align submissions with regulatory milestones
especially when dealing with personalized, complex therapies like DCVax-L.
Silence is not evidence of non-submission.
6. The conclusion about “going dark” and intent is speculation.
Saying that NICE conversations are “simply asking when submission can be expected” is an assumption. There is no public basis to assert that — and NICE does not disclose the content of those discussions.
You’re right that NICE allows early evidence submission and preparatory work ahead of approval.
But it’s incorrect to imply that reimbursement can be effectively secured pre-approval, or that the absence of public updates proves NWBO has failed to submit evidence or is misleading shareholders.
If you want to argue mismanagement, the argument has to rest on verifiable facts, not on inferences drawn from a process that is largely confidential by design.
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