NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

It's possible there are questions about the control used here, but I feel that the most dire consequence this should lead to, in my opinion, is requiring another confirmatory trial with an enrolled control group, not an external comparator.

The trial was randomized to 232 with -L + SOC vs 99 with placebo + SOC. Primary endpoint PFS secondary OS.

OK, the PFS failed and no argument that psPD could be a cause.

But the OS between the arms showed no improvement. We do not know the trend, but the fact that NWBO has refused to disclose that number makes i.t clear it is not good.

So knowing this, years after the trial was over. they changed the comparison to be against and external control arm that was a mixture of several trials summary data. Not even patient level data.

I could go on, but it is pointless as the above is enough to make clear they have issues.

EDIT:

As a side bar, when the FDA placed a hold on the trial after the efficacy IA in 2015, NWBO said they hoped to get recruitment restarted soon. Never happened so the trial never completed planned enrollment. Should be kind of obvious what happened.