NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

I am a big fan of the best drug/therapy for each subgroup that can be identified up front. Linda Liau and Dr. Prins both point at the mesenchymals as the standout subgroup for DCVax-L.

Therefore; worst case scenario I would hope would be pursuit of the mesenchymals or methylated mesenchymals. Not saying they should not or will not get approval for everything, just saying that narrowing to the mesenchymals appears to me to be the worst case scenario.

If that were to happen, they may or may not be powered for that if there is a big hit for them not having called that subgroup in advance. They appear to be powered for a 40% subgroup... but not sure if that is at this point, or at full trial enrollment + maturation.

Worst case scenario they are denied whatever is being considered now, and enrollment narrows to screening for mesenchymals or methylated mesenchymals as they move forward to speed the process. Screening may not be the right word if they have to examine the tumor to see if someone is mesenchymal. If they do need further patients, it might not be very many.

If the numbers shown in the early data prove out in Ph 3 then they are probably done for that subgroup even if there is a big hit for not calling it up front. I don't believe that the FDA would just flat out deny great efficacy results for a universally accepted GBM subgroup. This assumes there is a practical means of identifying this subroup before treatment selection without damaging the utility of other potential treatments.