NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Let's just look at this matter head on.

At the time your resident bears are screaming futility for PFS must have occurred -- aka: around summer 2015 -- the trial was still about 16 months away from getting down to 75% PFS events occurring! OK, for those who don't know it, that is unbelievably slow eventing for PFS in a GBM trial. SOC would have normally had 97% events by November 2017. All patients had not even been enrolled quite yet in the summer of 2015. Most of the patients would have not been in the trial for even two years. One year stats for survival were high -- almost 90%.

The chances of futility, are very low, because the threshold for any first IA (safety or efficacy) is very high. The chances for futility are very low because it appears, from what was publicly provided, PFS eventing should have been very slow in a large group of the treatment arm. Something like 30% (maybe as high as 35%) in the treatment arm were likely way beyond where they should have been by November 2017 -- particularly if SOC followed anywhere near normal attrition. The chances for futility were very low because they removed early psPD to reduce confusion between that and PFS events. You'd have to draw an incredibly funny looking curve with the above knowledge to get to futility. Essentially DCVax-L patients would have had to drop PFS (or misdiagnosed psPD events) events like a rock and then take a 90 degree turn at 30%. SOC would have essentially PFS evented very slowly then dropped like a rock. Essentially you'd need very strange curves to get where they were by December 2017 and still have had futility in the summer of 2015. Highly unlikely. IMHO.