As long as we are talking about hypotheticals, what if after failing to produce significant ORR, Bavi converted the immune system of the patients from that of H. Sapiens into that of Kryptonians? Since on earth we are in the presence of a yellow sun, the Kryptonian immune system would eradicate the H. sapien cancer cells and produce a 100% cure rate. Would the FDA approve that?
Bad example. Yes, the FDA would approve that because if they didn't Superman would fly over and destroy their headquarters.
All that is needed to make a happy life is within yourself, in your way of thinking. -Marcus Aurelius