AA ? Hi Noteable. I am a committed shareholder. New to this board, usually on ST. I do not think AA is in the cards pre-P3 on mPDAC for two reasons and that's the fact that this is a combination therapy so it's a bit harder to prove what is causing efficacy to the FDA, add to that the small trial size. If this were a monotherapy then this would have been done already. This is why the company has clearly communicated repeatedly that an adaptive P3 is needed. An adaptive P3 will have surrogate endpoints and frankly it shouldn't take too many patients to show that this works, whether by ctDNA or ORR/PFS at around 6 mos at the FDA's whim, and then at that point yes AA. It shouldn't be a full P3 to get there. It's doable even for little ONC maybe a 40-50mm raise total.
This is a pretty good article explaining:
https://ascopubs.org/doi/full/10.14694/EdBook_AM.2012.32.114
Re SCCA, that combo doesn't involve chemo. There's plenty of trials showing very limited efficacy for Atez, so a nonrandomized small sample size for an indication with no SoC there's at least a shot there for an early AA.
(https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.3508)