41% still have their bladder at 450 days...In this link " 2018 Bladder Cancer Guidance for Industry".
https://fda.gov/media/101468/download Page 6...paragraph 4...
It said " The goal of therapy in patients with BCG-Unresponsive NMIBC is to avoid Cystectomy".
In the last Corporate Presentation(23 Oct 2023), 41%(CR+IR) of optimized patients still have their Bladder at 450 days.
Just speculating here, but maybe the FDA want more data & clarifications on this 41% , because 41% that still have their bladder at 450 days is huge.
Another + for TLT-Ruvidar that the FDA will certainly take into account.