surgery unwilling or unable...what is impact???
consistently since my first post i have stated my belief MCNA will get approved with a label including the above..
IMO this additional labelling will have no negative revenue impact compared to what the FDA was suggesting as IMO all patients even before BCG are recommended typically for surgery (except for the unable)...
..consequently IMO every 2nd line patient would have refused surgery at least once (label or not)..
..my belief comes mostly from a) what was stated in Adcom and b) what i generally understand about treatment options.
..does anyone have any information that better enables us to make a view on the revenue impact of unwilling or unable???
TIA