FWIW, based on
https://www.fda.gov/patients/fast-track-breakthrough-therapy..., the "Accelerated Approval Program" appears to be designed for cases where the clinical benefit hasn't been proven, but the effect of the drug on appropriate markers has been.
Here's a specific example from the link above:
>"Using surrogate or intermediate clinical endpoints can save valuable time in the drug approval process. For example, instead of having to wait to learn if a drug actually extends survival for cancer patients, the FDA may approve a drug based on evidence that the drug shrinks tumors, because tumor shrinkage is considered reasonably likely to predict a real clinical benefit. In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually predicts that patients will live longer. These studies are known as phase 4 confirmatory trials."
I think the shady bit is that this probably wasn't an appropriate use of that pathway, and that the FDA wasn't acting in good faith.