NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

It seems there is a reasonable policy to get the info arm data out to the public and remain protective/blinded of/to the phase III trial proper (Of course), but there is also the expanded access arm, which, I'm just gonna go out on a limb here, is likely performing similarly to the info arm -- just less mature data.

I bet the resizing in the phase III trial proper, based upon radiation effects on white blood cell count and immune response in various external studies, was also partially founded on what they were seeing in the info arm, and yet the info arm still manages 40% over 3 years in the indeterminate group.

I'm still even more impressed, despite some decent counter arguments on Ivillage, that the double rapid progressive group achieved 15.3 months. The screening seemed quite extensive for that info arm double rapid progressor group and yet they basically tied the current MDAndersen SOC trial results for a much less aggressive GBM overall group (n = 833) reported in 2013.

Things happen in small samples that can trip up researchers, but it seems that every small sample continues to head in the right direction for DCVax-L.

Going back to that expanded access arm we have not seen results from. My guess is they additionally entered many patients who were originally treated earlier than May 2014, so if the results are starting to mimick what they saw in the info group, they'd have a right to tout their older info arm every chance they get. If they aren't seeing that trending in the expanded access group, I'd raise an eyebrow. My guess is that they are seeing the same trend. It still would not mean they can tell what will happen in the phase III trial main group -- although the info arm indeterminate group is far more helpful in informing them (IMHO) what they will see in the smaller 36 pseudoprogressor group, which I assume has PFS/OS numbers that are unparalleled.