2024 FDA track record for accepting/approving Phase 2 or 3 studies for NDA/BLA review that meet their primary endpoint has not been good. 3 examples are" 

Actinium. "FDA determined that the Phase 3 SIERRA trial is not adequate to support a BLA filing for Iomab-B despite its statistically significant primary endpoint"
https://ir.actiniumpharma.com/press-releases/detail/486/actinium-provides-regulatory-update-on-planned-bla-filing

Cellectar. "Due to recent communications with the U.S. Food and Drug Administration (FDA, or the Agency) regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131"
https://investor.cellectar.com/press-releases/detail/350/cellectar-biosciences-provides-strategic-update-on-clinical

Vanda Pharma. "Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review"
https://www.prnewswire.com/news-releases/vandas-letter-to-fda-commissioner-highlights-faulty-gastroparesis-nda-review-302346357.html

and the corresponding letter to the reviewing civil servant https://assets.vandapharma.com/pdfs/vanda-letter-to-dr-nikolov.pdf

And as Dr. Califf stated, "I think it's much like sports and to live with the decisions of referees...and worst calls of the game...and you live with it and go on,... if consistent bad decisions are made, then you need to look at the personnel and make a change."
https://youtu.be/zGrnzM51Jrs?si=lRr_C_j4CI8kPsPB&t=569

Except, living with a terminal condition like Acute Myeloid Leukemia is not like playing sports. 

As similarly stated in the article August 20, 2024 article, A Nuclear Approach: How Greed Delayed Patient Access to a Cancer Cure

"While greed in business is akin to winning and running up the score in sports, no one won when people were denied and delayed access to a cancer cure."