NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

That is a completely fair concern, and I agree with you. Reimbursement is not optional. It is essential. But in the UK, the system already has a formal pathway to support off-label prescribing when the treatment is licensed and the clinical case is justified.

That pathway is called the Individual Funding Request. NHS physicians use it when a patient needs a treatment that is not yet routinely commissioned. If the treatment is licensed and the physician believes the patient is likely to benefit in a way that is clinically exceptional, they can apply for NHS funding on an individual basis.

Here is what changes once DCVax-L is approved for glioblastoma. First, the product is no longer considered unlicensed. That matters because once it is licensed, any NHS doctor can legally prescribe it for another indication off-label, without needing regulatory approval or an experimental access route. That prescribing authority becomes active. Second, because the product is now licensed, the IFR process becomes available to support funding requests based on real clinical cases. This is how advanced therapies already gain access ahead of formal label expansion.

To be approved, the IFR must meet a few conditions. The product must be lawfully manufactured under GMP. That is where SI 87 and SIAD Regulation 7 apply. The prescriber must provide clinical rationale and informed consent. The patient must be considered exceptional, or the benefit expected must be significantly greater than average. And there must be early evidence, such as survival improvement or a measurable gain in quality-adjusted life years.

SI 87 plays an important role here. It ensures that the product can be legally manufactured and supplied for individual patients. Each dose is traceable. Each release is tied to a named patient under full quality assurance. That means every off-label use is not just legal. It is documented. And that documentation becomes data.

This structure creates a feedback loop. If DCVax-L is prescribed off-label and a patient survives longer than expected, or shows durable response, that outcome is not anecdotal. It becomes real-world evidence. That evidence supports future IFR approvals and can be used to justify broader funding. It may also support label expansion if the pattern holds across patients and tumor types.

So yes, reimbursement matters. But in this case, the pieces are already in place. The product must be licensed. The supply must be lawful. The outcome must be meaningful. When all three align, the system responds. That is how off-label therapies move from exception to standard practice—by showing they work, one case at a time.