RE:RE:"Black Box WARNING"...You don't have the right number LoveSD...here are DFS at 6 months, 1 year and 2 years respectively, for CIS containing disease & BCG refractory :
MCNA : 27 % / 18 % / 10 % (from FDA own briefing document)
Valrubicin : 18 % / 10 % / 4 %
So yes MCNA appears slightly superior to Valrubicin.
Don't think because a bunch of statisticians and non-orologists did not accept (in a 4 hours presentation) the benefit from a relatively small single trial that the FDA won't afte more than a full year of analysis. Anf the fact the MCNA' mecanism of action is similar to BCG might turned out to be a huge advantage...FDA has to look at the global picture. BCG shortage is a reality. If MCNA is able to induced a complete response in about 27 % at 6 months in a totally BCG refractory population (that mean a CR of 0 %), how effective would it be in a BCG-naive population ?
I can't see how this will not get a yes from the FDA for a narrower indication.
M80