RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:INVESTORS ARENT BUYING IT YETI get it that the Duration or response preferred by FDA does not statistically validate the efficacy of a treatment accurately. It kind of ignores pretty much all the No Response or Partial response Category of patients. The Point is FDA make the rules and we play by their rules. Cancer Slayer has tabulated it as
Keytruda CR rate = 41% (39/96)
Keytruda 12 month CR rate = 19% (18/96)
Ruvidar CR rate = 63% (41/65)
Ruvidar 12 month CR rate = 28% (18/65)
Correct me if I am not wrong, Ruvidar has 18 Patients with CR out of 65 evaluable patients. Keytruda has the same 18 Patients with CR out of 96 evaluable patients in their study. Keytruda has FDA approval based on this CR rate for a duration of 12 months. In the worst case scenario, let us assume that we reach the 96 patient and still have only 18 patients with CR we would be on par with Keytruda. Am I reading it correctly, in the worst case scenario going forward assuming all the rest of the patients do not achieve CR, Ruvidar would be on Par with Keytruda?? and there is a very good chance that FDA would approve Ruvidar? I have no question in my mind that Ruvidar would come out way ahead of Keytruda based on the Current FDA requirements for Data presentation and validation.