NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

IQVIA, the largest clinical trial operator, summarized the FDA's guidelines:
"The FDA expects sponsors to have a finalized protocol before initiating an external control trial. The FDA is looking to dissuade sponsors from adding the external controls after the completion of a single-arm trial, and instead, proposes upfront planning to allow inclusion of the external control arm design and analytic approach along with the trial protocol. It also asks that sponsors pre-specify their plan, how they want to measure the different aspects of the design and the data, and how they would analyze any confounders and reduce sources of bias. Design elements for consideration include the study population (Is it exchangeable with the experimental arm? Does it have the same eligibility criteria?); treatment (Are the treatments comparable?); immortal time bias (Are the timings from exposure to outcomes the same?); and, outcome assessment."

Clearly NWBO DID NOT DO THAT. They completely changed the protocol and added an external comparator TWO WEEKS BEFORE THE COMPLETION OF THEIR CLINICAL TRIAL. Clearly violating FDA guidelines. That's why NWBO didn't file for FDA approval.