Aaron Mitchell (@TheWonkologist), MD, MPH, medical oncologist and health outcomes researcher at Memorial Sloan Kettering Cancer Center, comes on to discuss the shortcomings and pitfalls of the regulatory processes at the FDA, optimal trial endpoints that provide the strongest evidence for approval, whether the accelerated approval process is enforced as it is written, what power any advisory panel really has when it comes to FDA approvals, and so many more pain points today.