NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

So what happens if NWBO decides to go for approval for the entire GBM population ("Win Big or Go Home"?), avoiding the handicaps of multiplicity and small subgroup sizes, while Celldex would clearly be shooting for only a subgroup, and would be fully powered in that sub-group?

I would think that NWBO would be allowed to change their minds about whether they want to shoot for the entire GBM population or some or all subgroups (all-subroups not being the same thing as the entire GBM population due to multiplicity and or powering issues) up until the point that they have efficacy data or feedback of any kind. So that; if that feedback was relative efficacy to Celldex within a subgroup, for example, NWBO would have to commit prior to that reveal.

Even though they had to define subgroups in advance, just in case they choose to use that later, they may not have been required to commit in advance to whether efficacy will be evaluated subgroup by subgroup, or as just one big GBM population.