RE:3 (or more) treatments
I don't think you are allowed to make changes that big this late.
You raise a good point about the number of treatments needed. I feel that once approved there would be easy room to test variation on the protocol. Such as doing a baseline treatment and then retreating any NR's at 90 days with a second. Or figuring out how fast the urine goes negative as that is cheap and easy. If looks like CR patients all go negative in the urine cytology by one month then you could have a way to retreat some and not other. So many options.