NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Huge pile of BS
You are just splitting hairs. Whether you call NWBO’s control data “RWD” or “historical ECA” is semantics.
What matters is that MHRA is preparing a formal framework to approve therapies based on external controls, and DCVax-L fits squarely within that scope

Yes, NWBO used pooled control arms from other GBM trials, not EHRs or insurance data. So? That still fits under MHRA’s broader definition of RWD, which includes data from registries, past studies, and external datasets. What matters isn’t what bucket you put it in it’s that the control arm was external. And that’s exactly what the MHRA draft guidance is about:
Approving drugs based on external control arms, especially when RCTs aren’t ethical or feasible.
DCVax-L fits that perfectly. Lethal disease? No standard-of-care control left? Big effect size? All boxes checked.

So stop claiming its this guidance isn’t about DCVax. It absolutely is.

Have you now become a bear and short? Interesting