Ann: Theranostic prostate cancer trial advances to multi-dose, page-22

Thanks for sharing your thoughts on this. One question I have is if a patient is responding to lower dosses eg 8 or 12GBq and the PSA levels go to undetectable levels after say 2-4 cycles, and then the entire drug washes out within a few days with barely any adverse effects, pushing for demonstrating MTD will put the health of the trial patients at risk when it is really not required for their treatment but required for FDA approval. Isn’t it?

On the contrary if there are patients who are not responding at 12GBq which is the current max dose after 4 cycles then it makes sense to either increase the cycles or dosage. However if CU6 is able to achieve better safety/ efficacy over SOC aren’t they already contenders for FDA approval? The acquiring company or CU6 themselves could do higher level trials at a later date for the small population who are not responding to current trials. I am thinking we are asking CU6 to try and demonstrate MTD when we don’t know whether it is 16 or 20 or 24GBq. And to do that trials would require additional drug manufacturing efforts, costs, time and further trials all for a small subset of patients.

JIMHO.