RE: Efficacy22 Sep 2025 12:33
MD Anderson are in charge of efficacy data. They own it. It is theirs to release when they wish. Vlads hands are tied.
MDA will want a big reveal at some point and it will definitely be sooner rather than later. ASH 2026 is too late imo. MDA have til October 29th to submit their late date. A late submissions permits are primarily driven by what has occurred since the main deadline. The recent P3 update including efficacy occurred post ASH submission deadline.
So is this significant event, added to p1 survived now 7 months and p2 now 4 months, all with clean safety profiles, enough? AI offers very encouraging opinion. Plus FDAs early approval of the peds trial after only 2 patient "safety" confirmed. To me all this offers compelling indications that it smashes the current standard of care out of the park and can improve the treatment of r/r AML across the Globe. And that Dr Short will want all the smoke.