RE:surgery unwilling or unable...what is impact???The good thing in case of the FDA-approval is, that TST will not suppress an US-blockbuster (BCG) from the commercial market, but only the surgeons will have some bladder-removals less. (we all know or heard about the FDA-US-pharma-lobbying).
I do not think that the FDA sees cystectomy as an "branch of industry" worth protecting.
TST could push at an open door with this - sufficiently discussed - narrowed label.
This could be the decisive turn.