Well, we have to differentiate two groups of the patients. One group is those patients with CIS with or without papillary tumors. In general, when a patient is BCG-responsive, the most recommended therapy is radical cystectomy. But this is a life-changing procedure with significant mortality and also complication rate. So for BCG-responsive CIS, there are four approvals so far in the US by the FDA, and we do not have any approvals in Europe, probably due to the lack of randomized control trials and being only one-armed trials...
Well, we have to differentiate two groups of the patients. One group is those patients with CIS with or without papillary tumors. In general, when a patient is BCG-responsive, the most recommended therapy is radical cystectomy. But this is a life-changing procedure with significant mortality and also complication rate. So for BCG-responsive CIS, there are four approvals so far in the US by the FDA, and we do not have any approvals in Europe, probably due to the lack of randomized control trials and being only one-armed trials. For papillary-only disease, there are no approvals. There are some clinical trials going on, like Sunrise 5 for Moonrise 3, and we still don’t have approvals. There are some clinical trials going on, like Sunrise 5 for Moonrise 3, and we still don’t have approval, so for me, the highest and main needs are finding bladder-preserving strategies, which we already have, and also the approval of these strategies by other agencies different from the FDA.
This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.