NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Clinicians (those involved in the P3 clinical trial) don't work for free.

"What is confounding? 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."

It is not a "statistical analysis" it raises questions about the validity of the statistical analysis. This is what regulators are left to sort out -- did the confounding factors make the trial unreadable. NWBO determined that the PFS confounding (the failed primary endpoint), justified tossing it out and doing a totally new protocol and SAP. That demonstrates the importance of confounding in trial results.