NorthWest Biotherapeutics Inc (NWBO)

[longusa]

Pyrr, can't fault your logic on the potential for limited low-CD4/WBC patients in the PhIII. On the other hand, NW saw fit to want to create a subgroup, so they see the possibility of an issue (and eliminated it as a possible reason for non-approval).

My theory is that the exclusion criteria of no progression post-SoC has created slower event rates in both cohorts; if the low CD4 issue is not seen much, this would add to the slower event thesis. And the slower event rates are what led the BSSR to generate N going from 240 to 348, while PFS advantage goes from 6 to 4.

Related to the low CD4/WBC issue, this is why Dr. Liau's PhII trial of DCVax-L with immune system adjuvants could be very important. If the adjuvant cohorts (the PhII has 3 cohorts: 2 adjuvants and 1 control) show better outcomes, these could be used to counteract low CD4/WBC issues.

Further, if the PhII shows positive adjuvant outcomes, then if DCVax-L gets approved, I would expect an adjuvant to be added to the DCVax-L protocol. As well, it would then allow the SoC to stay the same, with chemo, using the adjuvant to counteract the chemo effects.