What has been shown is that regulators can create a mess all by themselves and blame a company or drug at the end of it. They are being very careful when clearly the requirement of a placebo arm, and then the practicality of needing to make it a crossover or no one would join the trial, led them to this mess. The complexity of GBM, diagnosis, immune response, biomarkers and now the change in definition. NONE of that was NWBO’s “doing”. The drug was literally ahead of the diagnostics, ahead of our understanding of GBM and biomarkers.
All of that had to be gone back into and carefully constructed and understood from previous data that did not account for it.
So their ability to adapt, roll with the flow, save the trial from the absurdities they were faced with, is a testament to the fortitude of everyone involved, from Linda Liau to Linda Powers to everyone in between.
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