RE: Why are we different from most early stage biotech?7 Mar 2023 08:54
As described on Science Day, it's not so much a Phase 1b trial as a Phase 2/small Phase 3 trial. That would considerably shorten the time to market, particularly as the findings would become obvious before the doxorubicin patients finish their course and might even be switched to AVA6000 on ethical grounds before finishing their course. I wouldn't be surprised to hear news of FDA/MHRA/EMA orphan drug and particularly breakthrough/fast-track designation with news of a change to the trial protocol, or even a new trial protocol, when the next dose escalation is announced.