NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

FDA doesn't design trial -- they approve protocols or reject them with recommendations.

NWBO post on LinkedIn tells you that FDA only approved the trial from their posting:

"DCVax®-Brain has entered a Phase II FDA-allowed clinical trial, which is designed and powered as a pivotal trial (i.e. a trial from which a company may go directly to product approval)."

This trial was converted in their 16 year long P3 trial.