NWBO has repeatedly reported that the nGBM data is confounded. The rGBM is post hoc data dredged, never part of the trial plan until they ginned it up. FDA considers data dredged finding "exploratory" and certainly not pivotal.
"What is confounding?
Confounding is often referred to as a “mixing of effects”1,2 wherein the effects of the exposure under study on a given outcome are mixed in with the effects of an additional factor (or set of factors) resulting in a distortion of the true relationship. In a clinical trial, this can happen when the distribution of a known prognostic factor differs between groups being compared.
Confounding factors may mask an actual association or, more commonly, falsely demonstrate an apparent association between the treatment and outcome when no real association between them exists."
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