NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

Re: Screening Halt and Recent Increased Subgroup Knowledge:

Back before the screening halt, at the point where NWBO modified the trial for the lower PFS threshold of 4 months vs 6 months, I believe they also added subgroups or more subgroups.

Maybe they have learned more about subgroups since then. There is the Dr. Prins report... maybe that was the question you were addressing.

I had been thinking that the info in this new Prins et al report might be input to the regulators if they are making decisions based on an efficacy look; for this reason:

While NWBO may have specified subgroups such as mesenchymal, even if SS efficacy is demonstrated there still might be an issue of whether NWBO can identify that subgroup prior to starting treatment. Prior to treatment is pretty important if different therapies are vying for different subgroups.

Maybe NWBO can't easily identify mesenchymal before surgery. Or maybe not in a way that makes time and economic sense. But maybe it is close enough to identify that TIL count is high or ALC is high or both or something. Maybe that mostly detects mesenchymal... but not exactly, but close enough for hand gernades and DCVax-L. Maybe in fact... as I think you may have said... identifies Mesenchymal and a small number of non-mesenchymal where DCVax-L is also effective.

But you can't just make up subroups after the fact AVII would tell us, correctly. But maybe when the subgroup is so closely related, ie mostly detects Mesenchymal... you can. And so maybe that has extended this dramatic wait. Ie time for the agencies to consider these questions and these test results.