Something else to think about is if the original control arm no long matters does that lighten the need for investigation and inspections??
The N=99 control arm certainly does matter, does not matter how much the company and fan club deny it.
They gave 232 patients a blue pill following initial treatment for nGBM and 99 the red pill. That the blue pill did not live longer than the red pill is a huge issue. The RAs do not just allow the company to wave hands and assert it does not matter.