RE:RE:UUTUC Justforfun - please see below the definition of a Complete Response as has been agreed with the Regulatory Authorities for Phase II. The Company discussed this with them at length in the light of Phase IB and I hope that the last of the three categories of CR definition will finally put your mind at rest:
The Complete Response will be evaluated at 90 days`post-treatment with duration evaluated at 360 days`post-treatment.
Complete Response is defined as:
- Negative cystoscopy and negative urine cytology; or
- Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology; or
- Negative cystoscopy with malignant urine cytology if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative.
This will allow for the possibility of a Complete Response being defined in the bladder even if cancer persists elsewhere. Note that the CR is defined at 90 days` - i.e. before the second treatment which itself may or may not serve to systemically address cancer remote from the bladder.