Patients who remained in Study 2This quote seems to indicate that most probably initial12 not counted after 90 days. They started off in trial, ( hence included initially then dropped) and since were undertreated are now dropped after 90 days. IMHO
"The interim clinical data demonstrates a 90 days CR of 54% (n=52) and a sustained duration of response at 450 days of 67% (n=12), for patients who remained in Study II.
Note: To be included in the statistical clinical analysis a patient must be enrolled in Study II, provided the primary Study Treatment
and evaluated by a Principal Investigator (“PI”) at the 90 day assessment visit (cystoscopy and urine cytology)"
We will eventually get more details, but this must be in line with Statistician they are working with and FDA. Haven't yet called company.