NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Dennis, there’s no need to mock people when the facts are already public.

The connection between DCVax-L and the MHRA’s ECA/RWD reform isn’t just speculation, it’s documented.

Let’s start with the foundation:
In June 2022, the MHRA approved a Pediatric Investigation Plan (PIP) for DCVax-L that explicitly accepted the same design as the adult Phase III trial, using a contemporaneous, matched external control arm instead of a placebo. That decision, on record, shows that the MHRA had already signed off on the trial’s evidence structure long before any formal ECA guidance was published.

In May 2022 (just before that) Linda Powers testified before the All-Party Parliamentary Group on Brain Tumours (APPGBT). She was the only cellular therapy executive to appear. Her testimony argued against the ethics and feasibility of placebo-controlled trials in terminal cancer, and laid out the case for using pre-existing matched datasets as external controls.

The APPGBT’s final report incorporated those recommendations. That became the basis for what we’re now seeing in the MHRA’s guidance.

Fast forward to 2025: the MHRA published its draft guidance on the use of ECAs and real-world data. It states plainly that there is “no general scenario where the use of RWD external controls is explicitly ruled out,” and acknowledges that randomized controlled trials are not always ethical or feasible. This is nearly verbatim what NWBO put on record years earlier.

And when NWBO submitted its MAA in December 2023, they made it clear in the public domain that their submission was based on matched, contemporaneous external controls, not IPD, not a traditional RCT. This isn’t new, it’s the same design that was accepted in the PIP and later supported by MHRA reforms.

So when you say the ECA guidance has “absolutely nothing” to do with DCVax-L, you’re ignoring what’s been in motion for over two years. The application was built on the very structure that the MHRA is now formalizing, because DCVax-L was one of the drivers that forced the agency to do so.

The real story isn’t some hidden connection. It’s that the system changed because it had to.

NWBO didn’t follow the rules. They helped rewrite them.