NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

The OS24 for Optune was 43%.

Well, as we know there are several different datasets for Optune. The IA that garnered the approval, the 'final analysis' with a cutoff just a few months after the IA, and then the figures they quote on their website. Plus the ermm data (term used loosely) from the compliance subgroups in recent times.

I know you are only repeating their quoted figure, but, I take that with a large pinch of salt...

OS24 (PP) at interim analysis was 48%
OS24 (ITT) at interim analysis was 48%

These are the first 315 patients only (less than half of the ITT!)

A few months later at the 'Final analysis' of all 695 patients, it was:-

OS24 (PP) 37%
OS24 (ITT) 35%.

What do you think the OS24 might have been of the PP and/or the ITT, at that 'final analysis' if they removed the first 315 from the data, and cited data for the other 380?
Maybe 30%...?
Though perhaps even worse, because that 'final analysis' censored the majority of all the patients on the trial!
(351 out of 695..)

Have you ever known a trial that censors the majority of the ITT population?

As I've said before, the huge difference in OS24 between the two analyses is totally implausible to me, and renders the whole dataset questionable.

Most of the revenue which their are now using to run trials to extend their cancer indications, comes from the approval for ndGBM, that was granted on the basis of the data from the first 315 subjects (less 48 censors). Data that was significantly superior to that of the whole 695 (less 351 censors!)