RE:November 2022 Upcoming Report
RoseHeaven wrote: August 29, 2022 Report - # of Patients waiting for evaluation at each reporting stage
1) 90 days - 7 patients
2) 180 days - 4 patients
3) 270 days - 2 patients
4) 360 days - 6 patients
5) 450 days - 2 patients
These are the patients likely to get evaluated and to be reported in November 2022 report. It is very likely that only 2 patients would be evaluated at 450 days by November 2022 report making the total number of evaluable patients 26, only 1 patient more than 25 patients TLT was aiming for BTD.
If these 2 patients were evalauted as CR at 450 days (best case scenario), total CR pateints at 450 days to be 7 out of 26 evaluable patients brining CR to 27%.
I am expecting a big boots in CR at 360 days as 6 more patients would likely to have evaluated by November 2022 report.
Do you think 27% CR at 450 days is good enough for BTD?
Or TLT should wait for more patients to be evaluated at 450 days for BTD?
Thanks
RH
Quick answer....Yes.
Merck set a relatively low bar at 19%, and in order for a patient to reach that low bar, he must undergo "systemic" treatment (with its associated side effects) every 3 weeks...for up to 24 months as long as there is no disease progression. Such a treatment-intensive systemic treatment demands there be more patient-friendly & effective options....and both systemic & non-systemic (i.e. bladder instillation) options are what Urologists, the International Bladder Cancer Group & HHS/FDA are currently demanding.
Imo, the minimum required CR% for FDA approval depends on the type of treatment given (systemic vs non-systemic). Systemic treatments (like Keytruda) generally cause greater toxicity. Therefore, the minimum CR% needed for an approval may be higher for such a treatment vs an intravesical option. Considering our ACT is a non-systemic option, one could argue the efficacy threshold for our approval could potentially be even lower than what Keytruda has already established....not saying that will be the case.
All things considered, I'm feeling confident. Good luck...