Plausible scenarios Let's say the fast-track driven access to the FDA has given enough confidence to TLT that BTD is almost a given. Where would you spend your time and effort next? I would like to think it is in designing a trial that meets FDA guidelines for an AA. Maybe 4 treatments over one year and then monitor for 1 year after the last treatment, putting the AA grant timeline in the 2025 timeframe. Those 9 extra centers would be busy if they got BTD. Also, hoping that BTD allows them to collect some revenue till full approval granted. In the best case scenario they get BTD and AA together. Very long odds though.
In parallel, or maybe next, is preparing a trial to use TLD-1433 before BCG ie. under the Frontrunner program. This assumes the FDA also sees the potential for this PDC to be tried pre-BCG and indicated as much to TLT. The FDA needs to start using that Frontrunner program at some point. Given the safety profile and CR data, TLD-1433 seems to fit. IMHO.
Both of these options need $$. The options to raise money would be much much broader if they could get BTD first. VC, JV, Nasdaq listing, etc. If I see an attempt to raise money before BTD, my take is that they are scraping the bottom of their piggy bank already and have no clear indication of getting BTD yet, maybe because they're still collecting data for a more sureshot submission.
One can speculate.