NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

RK, the only way I would go over 6.6 months PFS post randomization (9.7 months post diagnosis) extreme high case scenario for placebo in the phase III trial is if I had a different understanding (than I do now) of the definition of intent for gross total resection.

My understanding is that they are considering tumors that are supratentorial. Beyond that, they will not accept biopsy surgeries into the trial. That means there will be a substantial amount of partial resections, even though there was intent for gross total resection.

In the main group for the Rindopepimut trials, there was 100% resection in all trial patients, and at the highest in all their trials, as I think you pointed out, there was a median PFS of 12 months post randomization (in another trial they were down to 9 months). I don't think the DCVax-L trial is getting anywhere near 100% of 100% resections based upon their inclusion criteria, and other than lacking biopsy patients, will likely come much closer to the typical patient profile.

Thoughts? (P.S. Obviously, for purposes of this inquiry, I am setting aside other factors previously discussed by both of us that may or may not affect PFS)