NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Hey Manibio

I don't know if ECA not having patient level data match is causing delay because MHRA's new guidance explicityly mentions patient level data in their ECA use as RWD. Please see my last two posts.

Yes but with important nuance.
Here’s what the MHRA draft guidance actually says:

“For studies using RWD to construct an external control arm, patient-level data should ideally be available to enable robust matching, control for confounding, and ensure population comparability.”

However, it does not say that patient-level data is an absolute requirement for regulatory acceptability. Instead:
It says patient-level data is preferred for bias mitigation, matching, and sensitivity analyses.
But it also allows for flexibility in cases where patient-level data cannot be obtained, if the methodology is still sound and sufficiently justified.
So it’s not a hard requirement it’s a strong recommendation.

NWBO likely did not have full patient-level data from the external GBM trials used in their ECA. That’s a limitation but: The MHRA knows this already. It would not take them 18+ months to figure that out. The guidance itself acknowledges exceptions are possible particularly for rare or lethal diseases. If lack of IPD was disqualifying, the rejection would have already been issued.

So: could the lack of IPD be part of why some MHRA reviewers are hesitant? Possibly. But is it the reason for the long delay? Unlikely. It’s a known factor and baked into the CHM review over a year ago. In rare, high-need cases like GBM, a well-justified ECA without full IPD can still be accepted. That’s exactly the kind of flexibility this guidance is designed to defend.

You don’t punish a company for not having access to data that doesn't exist.
You don’t let patients die just to collect placebo outcomes.
And you don’t drag out a decision for 600+ days, then pretend the lack of IPD is a surprise.

DCVax-L isn’t perfect, no trial is in GBM. But if regulators expect perfection in rare, lethal diseases, they’re not protecting patients, they’re abandoning them.

Btw I do believe this political choice is the sole reason for the immense delay. NWBO has put MHRA on the spot and now the MHRA will have to make a choice here. And thats why the invitation for public comments