RE:RE:May 29-31, 2020 Virtual ASCO MeetingYajne wrote: and importantly Adverse Effects in almost 84% of patients with serious AE's in over 12% of patients including one treatment-related death. And yet they conclude that efficacy "meets the benchmark for initial CR defined by FDA guidance"? Wow, seems FDA has set a pretty low bar, because maybe they're getting desperate for a treatment?
The new bar (~40%) set by our checkpoint inhibitor competition (including Keytruda) is still pretty low. We are in a unique position to really stand out from the rest. IMO, due to the mechanism of action of checkpoint inhibitors, there can only be a limited amount of antibody blockage due to the overwhelming number of receptors on cancer cells that need to be blocked, many of which are hidden/intracellular. I believe a single checkpoint inhibitor won't achieve much higher CR rates against NMIBC/solid tumors unless it is used in combination with other inhibitors/therapies.
If we get fast tracked, there is no stopping (T)he (L)ittle (T)rain that could. Good luck