NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

Dennisdave, Agree and well said. I am putting 1 +1 together.

1. MHRA Draft Guideline on the Use of External Control Arms (ECA) Based on Real-World Data (RWD)
Draft publication: May 20, 2025.
Consultation closes: June 30, 2025
Implication: By early July, MHRA has all feedback, and can theoretically implement the principals of the final guidance document
Key: Directly validates DCVax-L MAA’s use of ECA methodology

2. SI 2025 No 87: The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
Date signed into UK Law: January 23, 2025.
Effective Date: July 23, 2025
Key: DCVax-L approval under this law, automatically includes the regulatory framework (the “blueprint”) and should expedite the approval and scaling of the automated Flaskworks Eden system for commercial use.

The convergence of these two events into July 2025 tells me that the UK government and MHRA are proactively shaping the regulatory environment to embrace and facilitate the approval of innovative, complex, and personalized medicines. I believe these laws had approving DCVax-L in mind when they were put together. As an investor this looks very positive, and the UK is being very supportive.