NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

You’re trying to have it both ways, framing the MHRA’s continued engagement, referral to CMP, and expansion of compassionate use as signs of “justified caution,” while still floating the idea that the Phase 3 trial might be fatally flawed.


But here’s the problem with that logic:

If the DCVax-L Phase 3 trial had “serious issues that may not be surmountable,” you would not see:

None of that is compatible with the idea that the trial design or data are fundamentally broken.

And the UroGen analogy falls flat for a simple reason:


The FDA did raise concerns with UroGen’s trial design, but those concerns were transparent, documented, and discussed publicly during review. UroGen had to submit additional post-hoc analyses and clarify endpoints. That’s not evidence that regulators “overlooked flaws.” It’s evidence that regulators worked through limitations openly and approved based on clinical benefit that outweighed the concerns.


So if you’re invoking UroGen as a parallel, what you’re actually doing is confirming the path NWBO is already on:
➡ Accepted despite imperfections
➡ Reviewed at the highest level
➡ Potentially approvable because the survival benefit is real

📌 The bigger truth is this:


The DCVax trial was unconventional by necessity. Delayed treatment, external controls, and MAIC were used to ethically and scientifically navigate a deadly disease with no good options and no realistic placebo uptake.


And that’s exactly what current regulatory frameworks, especially SI 2025 No. 87 in the UK, are built to accommodate.


So if you’re trying to suggest the trial is “unsurmountably flawed” while MHRA is still reviewing it under a new PICV classification, you’re either uninformed or pretending to be.