Replies to post #773341 on NorthWest Biotherapeutics Inc (NWBO)

[barnstormer]

We can argue ECA, RWD, RWE, or even RCTs all day long. Regardless, the MHRA has had the data and known the sources for nearly 18 months and only now are getting around to putting a proposed guidance out for input from interested parties. I don't see anything that should have been prevented this being done 6 months or more ago.

[Investor082]

How did that Project Orbis thing go that you were pumping about for months about 4 years ago?

And what about worldwide approvals & reimbursement approvals that you’re also pumping around the same time for months?

Since you are active again, one thing is clear. Share price ought to go down in the coming days/weeks. That never fails, LOL!

[jimmy667]

Yes this is correct. Thank you ATLInsider. NWBO used an external control arm (ECA).  The discussions of ECAs consisting of Real World Evidence. In other words the Data collected from the treatment of patients in a treatment setting rather than a clinical trial might be considered when other Control groups are not available or to supplement those control groups. This may be important in future NWBO trials to expand the label of DC-Vax-L.As I read you post you are saying the External Control Arm in the NWBO trial was a carefully "distilled" ECA consisting NOT of RWE but of a careful amalgamation of control arms from other published clinical trials.One of the main features and conclusions of the JAMA Article was the agreement with and validation of the ECA consisting of a amalamation of other contemporary clinical trial control arms done by subject matter expert researchers contracted by NWBO. Everything about this ECA analysis done on behalf of the NWBO trial was cutting edge top notch science. The JAMA Article is essence declared the ECA methods used by the NWBO outside experts as the new current State of the Art. 
Now MHRA is codifying this use of ECAs as used by NWBO as one of the methods of ECAs recognized as legitimate in regulatory practice. This same proposed also recognizes RWE as legitimate. But RWE was not the NWBO trial  control arm. RWE would be the clinical experience of the results of the specials "compassionate use" patients for which patient level data is available. Thank you ATLINSIDER for clearing up some of the fuzzy thinking regarding the NWBO clinical trial ECA. Actually JAMA has already declared the methods used as the new State ofthe Art and the Groundbreaking NWBo Trial as an unmitigated success.
Success of NWBO is assured beyond even a sliver of doubt.
 The only doubts are from criticisms and disparagements from compromised and possibly criminal actors imposed upon the fuzzy thinking of weary retail investors. 
Focus people. JAMA verified the soundness of the science. MHRA is codifing the NWBO trial ECA trial protocol. When MHRA approves DC-Vax,-L the market for NWBO stock will 'flash over". 

[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