Sounds like the FDA has already made their decision imho(From the FDA AdCom briefing documents)
10.6 Risk-benefit-analysis
In a subpopulation of subjects with CIS-containing disease who received MCNA treatment, 27% of subjects experienced CR at 6 months that appeared to be durable without cystectomy. Because of the considerable morbidity associated with cystectomy, these subjects could conceivably be considered as having gained some benefit from the MCNA treatment without cystectomy. However, it is unclear whether some of these subjects could gain a similar benefit with other treatments, including retreatment with BCG.
Cystectomy is strongly recommended for patients who have high-risk NMIBC refractory to BCG. Many subjects with CIS-containing disease who did not experience CR at 6 months or who did have a CR at 6 months but did not maintain it beyond 24 months had cystectomy and some developed metastatic bladder cancer. Therefore, the questions remain whether these subjects had been placed at higher risk for developing invasive and metastatic disease by receiving the MCNA treatment rather than cystectomy upfront, and whether the treatment effect size would justify that risk.
In conclusion, it appears that patients with CIS-containing disease refractory to BCG therapy might represent a population that could benefit from MCNA therapy, i.e., some of these patients may not need immediate cystectomy. However, frequent follow-up and vigilant surveillance would be needed to mitigate the concern that delaying cystectomy may increase the risk of the development of invasive disease or metastatic bladder cancer. In the event that the CIS- containing disease persists after initial MCNA treatment, patients could be referred to have immediate cystectomy. In this context, FDA is seeking advice from this advisory committee on whether MCNA treatment has a favorable benefit-risk profile in patients with CIS-containing disease refractory to BCG therapy.
(appears the FDA favors a lessor indication CIS imho only)