Replies to post #790834 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

The official source for hazard ratios is the JAMA Oncology publication (Nov 2022), which reported:
* Minimal residual disease (near-total resection): HR = 0.95 (95% CI, 0.73–1.22) ? essentially neutral.
* Significant residual disease: HR = 0.65 (95% CI, 0.48–0.87) ? clear benefit.
* Overall newly diagnosed GBM: HR = 0.80 (98% CI, up to 0.94).

So the point still stands:
* The near-total/minimal residual group looked neutral, not favorable.
* The residual-disease group showed a survival advantage.
* The debate isn’t whether the subgroup HR was 0.95, 0.99, or 1.01 — it’s whether regulators accept the residual-disease signal and the long-tail survivors as credible evidence under their RWD framework. Given the MHRA’s own published guidance (https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions), they will.

So thus and therefore: JAMA paper = hazard ratios. NYAS slides = forest plots without numbers.

PS, what I agree with you is that the DCVAXL trial data and application is NOT a walk in the park review, as many longs claimed it would have