Project Frontrunner Based on this overview, TLT seems to check all the boxes for being a candidate. What I can't tell is if the drug sponsor (TLT) has to start a phase 1 trial again. It does feel like that based on the wording ie. Design the trial with intent to seek approval in an earlier setting of the targeted application. That's not how the current NMIBC trial is designed (starting point is after failing BCG). But even getting considered for this would be a huge boost given the safety profile and efficacy so far. In the meantime, we wait for any news. To BTD and beyond.
https://www.fda.gov/about-fda/oncology-center-excellence/project-frontrunner