NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

Not peer reviewed? Really, what were they, baseball players? 🤣

Here ya go snowflake. By the way, do you know what "another confirmatory trial" means????
Good luck waiting for any RA to approve this horrifically run PIII trial. Better chance of seeing a unicorn.
https://www.sciencedirect.com/science/article/pii/S0035378723009190
https://pmc.ncbi.nlm.nih.gov/articles/PMC10296384/
https://pmc.ncbi.nlm.nih.gov/articles/PMC10076936/

When considering PFS data, the study is negative, and the trial did not reach its prospectively defined primary endpoint. Therefore, from a purely formal point of view, the study should be declared negative.

The comparison of the investigational arm with an external control group should be considered a post-hoc retrospective analysis, suitable for generating hypotheses but not providing high-quality evidence. Non-randomized externally controlled studies are gradually becoming attractive because they are faster, cheaper, and limit the number of patients exposed to substandard or ineffective interventions, but they are inadequate for a phase III trial and require a pre-specified detailed protocol and robust statistical methods to minimize the risk of bias