Replies to post #805963 on NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

That would not surprise me. The female head of MHRA retired in March. I would venture to guess, she was Partial to LP
Just an opinion, not an accusation.

[sentiment_stocks]

Haha...

Both the original CHM Chairman & MHRA CEO who publicly supported DCVAX-L at the point of application filing, were replaced during the MAA consideration process, due to, I suspect, a lack of impartiality (ie the 'Special Relationship' )

You mean these two new guys?

Professor Sir Munir Pirmohamed, Chair of the UK's CHM
Dosing adjustments for clinical factors are usually based on data from observational studies and case-reports/series; however, regulatory authorities do not enforce a requirement of RCTs to deliver evidence that adjustments based on clinical parameters lead to an improvement of clinical outcomes (Pirmohamed & Hughes, 2013)
2013

From Google AI:

Professor Sir Munir Pirmohamed, a leading clinical pharmacologist and Chair of the Commission on Human Medicines (CHM), has recently highlighted the transformative potential of External Control Arms (ECAs) in modern clinical research.

Role and Vision for External Control Arms
Methodological Innovation: Sir Munir emphasizes that ECAs are pivotal for evaluating new treatments in areas where traditional head-to-head trials are difficult, such as rare diseases and oncology.

Improving Trial Feasibility: He supports the use of ECAs to address the challenges of identifying and recruiting enough patients for robust assessment, particularly in the context of precision medicine.
Ethical Considerations: ECAs can replace traditional placebo arms in scenarios where it would be unethical to withhold treatment from a control group.

Regulatory & HTA Acceptance: Despite their promise, Sir Munir notes that acceptance of ECA-based evidence varies globally. He advocates for greater transparency, robustness, and consistency in how Health Technology Assessment (HTA) bodies evaluate these designs to ensure data clarity and minimize bias.

MHRA Chief Executive Lawrence Tallon

Just today, we’ve launched a consultation on new guidance for using real-world data in trials, specifically through external control arms. This type of anonymised data, collected during routine care, can help address some of the challenges faced in rare disease or cancer research – where large, randomised studies aren’t always possible.
May 20, 2025

Both of these men seem well aligned with the necessity of ECAs, Real World Evidence, etc., and will likely impart a fair and impartial consideration to an approval of DCVax-L.