Important Note from the Valstar Advisory Committee Recommendation. After Valstar was initially rejected by the advisory commitee, they agreed to recommend approval with the following caveat:
In the end, the committee decided the study data failed to support the wisdom of using Valstar as an alternative to cystectomy in patients medically able to undergo the procedure but who refuse to do so. "It voted 9-to-2 with one abstention to approve Valstar only for those patients in whom cystectomy is medically contraindicated."
https://www.cancernetwork.com/articles/three-months-after-voting-nay-odac-backs-valstar-approval#sthash.VCxlaQnz.6Us4PKvr.dpuf