FDA Comment: FDA Comment: It should be noted that all subjects from Studies 301 and 303 received prior treatment with BCG, and these studies did not enroll any BCG-nave subjects. Thus, it is unclear if the responses to MCNA treatment observed in these trials required prior treatment with BCG to prime the MCNA response.
OK, good enough, but since we were attempting approval for a second line treatment, the patients will always be treated with BCG before MCNA. So why does it matter?