RE:Clinical Trial Inclusion Exclusion CriteriaYou have to read Exclusion 8 more carefully to understand that the first few patients were within the criteria set for this clinical trial. NMIBC in the upper tract is allowed; i.e., any of the T0, Ta, or Tis stages in the upper tract was not cause for exclusion. That means that papillary carcinoma (as in Ta) and flat carcinoma (as in Tis) were not cause for exclusion. Specifically, Exclusion 8 excludes "extravesical disease" which would be carcinoma that has begun to invade the muscle layer (MIBC). The inner layer of tissue (mucosa) is the same in the ureters and the catch basin in the kidneys as it is in the inner wall of the bladder, and the cancer staging throughout is the same. The supposition in the Nov. 8 NR was that seeding from the untreated regions above the treated bladder itself resulted in recurrence in the bladder, but the NMIBC in the treated bladder showed no progression, a result consistent with the supposition. Your belief that the patients didn't meet the trail criteria appears to be in error.