NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

If you look back and find the company PR's announcing the expansion of the trial to reduce PFS threshold to 4 months from 6 months, the same PR's state that they have added subgroups.

Every time you add a subgroup you add a chance at a win that did not exist before, and increase the odds of winning by a statistical fluke. For that reason, you eat up some limited amount of such fudging. I have forgotten the vocabulary, but remember the principles. They make sense.

Flipper and Pyrrho and AVII (in particular) and many others are more knowledgeble of these statistical issues. Maybe they will chime in.

I don't know if this is the same issue, or completely seperate, but straight math wise, statistical significance for a 40% subgroup would be much harder to achieve than for the overall trial; simply because there are fewer patients in the subgroup. I don't know if the FDA holds to that issue strictly or not.

However, for this trial, if the approx 40% mesenchymal subgroup demonstrated efficacy anywhere near the levels suggested by the mature Phase 1 data (assuming it was representative data which many, including AVII, have argued it was not) then in spite of being a smaller patient population, statistical significance would easily be achieved in the phase III.