RE:RE:RE:BCG-Unresponsive Non-Muscle Invasive Bladder Cancer CarcinomYes, a pre-BTD meeting late December followed by BTD submission in Q1 is what it sounded like. Will know soon enough if the story has changed again. You would think the FDA has all the info it needs by now, especially given the FTD status since 2020. But we've been here before.
bmk211 wrote: I thought per the zoom call they were submitting a pre btd. It's not pass or fail for that probably no news to give regarding a pre btd. The BTD they said would be submitted early 2025 I thought.