"...no question in my mind they should get the ICI as soon as their PD-L1 numbers show they could benefit. And that is pretty much standard practice now, to give people ICI's when their PD-L1 numbers reach a certain level. So approving an ICI in this trial would be consistent with clinical practice.
By definition, anything less than standard practice is malpractice. This shouldn't be a difficult decision for a science-based FDA.