No argument here. Totally redesigning a clinical trial 12 YEARS after it started is pretty incredible. Redesigned the protocol, changed the primary endpoint (when they knew they would fail the original), change the comparator to a cherry picked set of trials for an ECA (multiple trials had different screeners).
Incredible amount of bias introduced. And the FDA wouldn't buy it -- so NWBO, out of desperation had to find another regulator to pitch their "updated" trial. FDA had followed the trial for over 12 years and saw all of the NWBO manipulations.