NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

YES great pickup, Senti,

This has been raised before in the context of IFR, but it’s worth laying out clearly because the details are important.

SI 87 is the legal mechanism that enables DCVax-L to be supplied and used in the UK today, even before a marketing authorization has been granted. It currently applies to GBM, because the product is still unlicensed. Once approval is granted for GBM, SI 87 would no longer apply to that specific indication, but it would continue to apply to all other unlicensed indications, including breast, lung, pancreatic, and others.

What SI 87 Allows:

SI 2025 No. 87 amended UK medicines law to expand the “Specials” pathway for unlicensed medicines, specifically patient-specific ATMPs like DCVax-L. It allows manufacturers to legally supply a product without a marketing authorization if:

• It is made for a specific named patient
• A licensed physician provides clinical justification
• Manufacturing occurs at a GMP-compliant Control Site
• The product meets traceability, sterility, and MHRA inspection standards

Importantly, there is no restriction on indication. A treating physician may prescribe the product for any cancer type, based on clinical judgment.

It also allows cross-border logistics: tumor tissue can be shipped into the UK from other countries (such as the U.S.), the product can be manufactured at a licensed site like Advent, and then returned to the treating country for administration, all under legal protection.

Real-World Application:

This is the exact mechanism under which DCVax-L is currently being used in the UK. The legal foundation is already active.

IFR (Individual Funding Requests) are used separately to request NHS payment for treatment on a case-by-case basis. Some patients have received DCVax-L through this channel without cost, while others have self-funded. IFR controls who pays, but SI 87 controls whether it can be legally supplied at all.

Once DCVax-L is approved for GBM, future use for that indication will shift under the marketing authorization. However, SI 87 will remain fully valid for all other cancer types, allowing physicians to prescribe it for off-label use without waiting for new clinical trials or formal extensions of the label.

In summary: SI 87 is not just a theoretical access mechanism, it’s already live, already in use, and central to how DCVax-L is currently being deployed in the UK. And when approval comes, it will still serve as the bridge to broader cancer use beyond GBM.