This is why there is a fast-track to accelerate break-through treatments, which dostarlimab utilized (but stalled thanks to covid): https://www.fda.gov/patient

This is why there is a fast-track to accelerate break-through treatments, which dostarlimab utilized (but stalled thanks to covid): https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review https://www.fda.gov/patients/learn-about-drug-and-device-app... But, yeah, the FDA is all over the place.