NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

I posted my take on the IDH mutation work a long time ago which is this…

It is unlikely that in the window of time before database lock and SAP finalization that NWBO would have been able to obtain and test placebo patients from ECA trials to clean the ECA of IDH mutants. So why would NWBO undertake this?

My belief is that the data analysis will be post hoc and used a few ways. First, I believe it was essentially and FDA requirement so as to address concerns FDA has for future GBM trial once DCVax becomes SOC. They want to use treated DCVax arm in future comparisons and will likely require NWBO to run a 5 year open-label safety trial to beef this up. The other is that the post hoc analysis will be shared with both regulators and physicians as assurance that the efficacy seen was not limited to that patient type. Finally, since they are part of the trial but not part of current diagnostic criteria, I believe that the label will specifiy approval for both GBM and IDH mutant brain tumors. The collection of the data is a priori, but the analysis is post hoc or exploratory and part of what is considered sensitivity analysis.