RE:RE:$tltff The FDA wants an option that has rates better then I personally think CR will be 70% plus at 90 days and around 50% at 6 months and 30-45% at 12 months on. However anything significantly above Keytruda's 41% at 90 days and 19% at 12 months will look awesome and grant us an Approval IMO, given vastly better safety profile, better efficacy and patient friendly One single treatment option ( pleas a maintenance at 6 months) All of this will be taken into account by the FDA/ Health Canada. We would be most effective single agent to date as well. Merck would probably want to combo Keytruda with us for NR's and for MIBC. All IMO, but the next few months will be very telling. After speaking with Dr Mandel, he let me know that the company was very satisfied with the results and they were fully focused on this PH2 trial. Nothing else to report that is not known by all. GLTA
Rumpl3StiltSkin wrote: This patient population is elderly, fragile, who knows why they don't always have a CR at 90 days. 1433 has a log 3 kill rate in the test tube. If I were a NMIBC patiet I'd give it a try, certainly if they can get the 90 day CR % up into the 60s. IF I were then NR I'd try it again at the next 90 day period. Especially if I had a PR....
The safety profile is so low on this I can spend a few unfomfortable hours every 3 months until I get to CR. Maybe this will buy some patients extra time w/o losing their bladders?
I think the final NMIBC 90day CR will at least be in the 50s but probably better and into the 60s.
For other Cancers with less complicated dosemetry/treatment issues possibly higher %s.