Confounding raise questions about the legitimacy of the naïve OS endpoint.
NWBO has reported it in two SEC 10K filings. Confounding in clinical trials is defined:
"Confounding is often referred to as a “mixing of effects” 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."
NWBO and FDA both know this is an issue and it may lead to rejection of the naive OS indication
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