RE:66% the number to beat... Based on the data thus far from optimized patients, it certainly looks like a threshold we can beat.
In view of the natural/lethal course of BCG-unresponsive CIS & the negligible efficacy/limited number of available "non-invasive" treatment options, the FDA gave appropriate guidance imo. It states it does not recommend or require any pre-specified response rate. Such guidance certainly works in our favor, & even though a 66% CR rate appears attainable (especially post "two" optimized treatments), the threshold for approval is likely significantly less imo. Keytruda & Valrubicin got approved based on significantly lower complete/durable response rates that left a lot of room for improvement. We've already exceeded Keytruda's CR mark of 41% based on 33 patients, of which 45% (15 of 33) didn't even get the two fully optimized treatments as currently recommended.
I don't see how this ACT doesn't maintain at least 41+% CR mark moving forward. As I stated in an earlier post, I really don't see how this doesn't get approved. JMO.