NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Confounded data can't be "mitigated" after it is confounded. NWBO knows the risks, that is why they reported it in their SEC filing. The PFS confounding gave NWBO the out to toss they failed results. But they have nothing else to lean on other than the OS data which is also confounded. FDA clearly understands the issues with confounding. In case you missed it - here's the definition and implications of confounding:

"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." FDA certainly knows this.