NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Koman,

Quote:

So there is every reason for the regulators to tell NWBO to just design another p3 trial with OS as the primary endpoint and no cross-over if there was any hint of OS difference in this current p3 trial. Don't blame the regulators for doing their job.
-koman-

Well yes but.. the crossover was mandated due to an invasive procedure for the placebo and active treatments. The need to retain patients for assessment of secondary endpoints (with a change to OS co-primary in mind perhaps from the .03 alpha spend reserved) necessitated the cross-over as well.

This treatment may be showing efficacy signals on multiple levels. It may show stand alone efficacy with mesenchymal GBM genotype with regard to PFS and OS, stand alone efficacy in mesenchymal phenotype at crossover in OS and potentiation/repotentiation of checkpoint inhibitors and various chemo/radiation therapies with PFS and OS. With this kind of activity possibly going on, FDA will want to figure this all out especially with the biomarker correlations to survival in hand. The data from this trial is just too valuable given that patients are living longer than a 24 month median. Living longer is the gold standard right?