NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

The technical definition of Real World Data (RWD) you are using is correct, but that isnt your thinking problem; you're missing the larger regulatory context unfolding right now with the 2025 MHRA draft guideline, which you did not quote. Here's where your interpretation falls short:

1. Yes, DCVax-L didn’t use “pure” RWD
No one seriously claims the ECA for DCVax-L was built from electronic health records or insurance claims. It wasn’t.
It used pooled patient-level control data from other RCTs, and you're right that this doesn't meet the strict definition of RWD per the 2021 guidance you linked. But that’s not the end of the story.

2. The 2025 MHRA draft guidance — which supersedes the 2021 framing — says this:

“Many of the general principles would be relevant for external controls drawn from other sources, such as previously completed clinical trials.”

Let that sink in. The MHRA explicitly includes DCVax–L–style ECAs (built from other RCTs) within the scope of the new guidance. It’s not just about EHRs and Fitbits anymore. This shows the MHRA is building a flexible framework because it has to, especially for rare, high-mortality diseases like GBM, where full RCTs are often unfeasible or unethical.

3. You’re technically right, but logically way off
Yes: NWBO’s data isn’t “RWD” in the traditional sense.
No: That doesn’t matter — because the MHRA says the new guideline’s logic and standards still apply to ECAs drawn from other sources, like RCTs.
That’s why this guidance is so important: it provides the regulatory logic to approve trials that rely on external control dataeven if that data doesn’t qualify as RWD under the narrow 2021 definition. Why you are resisting guidelines that will help NWBO to succeed is beyond me. I thought your lve for NWBO would be bigger than the hate of me?

The MHRA isn’t hung up on terminology. They’re building a framework that can accommodate exactly what NWBO submitted. Whether it’s RWD, hybrid ECA, or pooled RCT control data — the principles of bias mitigation, transparency, and pre-specification are what matter.
And by explicitly saying their guidance applies to external controls drawn from clinical trials, the MHRA effectively brings DCVax-L inside the regulatory tent.

So yes — NWBO didn’t use RWD.
But yes — this guidance still supports their design.

So stop confusing your fans with hair splitting. You are pushing some of them to sell with your nonsens