NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

You're splitting hairs on the definition of RWD vs ECA in a way that misses the broader regulatory context.
Yes — NWBO used pooled control arm data from contemporaneous RCTs, not data from EHRs or wearable devices. So no, their ECA isn't RWD in the strictest definition. But you're omitting what the MHRA’s own draft guidance actually says.

“While the guideline is specifically aimed at sponsors planning to use RWD ECAs, many of the general principles would be relevant for external controls drawn from other sources, such as previously completed clinical trials.”

In plain terms:
RCT-based ECAs like NWBO's are within the scope of this guidance. That’s not my interpretation — it's the MHRA’s own wording. They explicitly built a flexible framework to support multiple ECA types, not just those based on health insurance claims or EHRs.

So while you're technically correct that NWBO didn’t use RWD, you're wrong to suggest that this excludes their ECA from current regulatory relevance. The MHRA is clearly moving to formalize methods that were already applied in the DCVax-L submission.

The ECA used by NWBO — reviewed and validated by JAMA — is precisely the kind of evidence that’s being normalized in this evolving framework. And the MHRA is not asking whether this approach is acceptable — they’re asking for feedback on how to phrase the principles.

NWBO's ECA still fits within the scope of MHRA’s new guidance The idea that this excludes NWBO’s approach is legally and scientifically incorrect

Then your points here
“Success of NWBO is assured beyond even a sliver of doubt”
This is pure hyperbole. Regulatory approval has never been guaranteed, even for strong submissions. While the ECA methodology is now explicitly within regulatory scope, we still don’t know the MHRA’s final verdict — or whether any data integrity concerns, inspection issues, or internal disagreements could impact that outcome.

“JAMA declared the NWBO ECA as the new state of the art”
While the JAMA article was highly favorable, it did not declare this the universal gold standard. It praised the method's appropriateness for the context — but didn’t claim it should supersede all other methods in every indication or trial setting.