MRNA/MRK may seek accelerated approval for melanoma cancer vaccine based on phase-2 data; a phase-3 trial is expected to start in 3Q23 (which could serve as the "confirmatory" trial for an AA): https://finance.yahoo.com/news/1-cancer-vaccines-poised-unlock-011448754.html It is by no means clear that the phase-2 dataset is sufficient for an FDA accelerated approval, but MRNA likes to talk a big game.