RE:RE:How does Accelerated Approval work The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are (then) required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.
A confirmatory trial could simply be following the cohort you have enrolled in your registration trial, Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the FDA, such that a company's Phase 1/2 cohort is simply reconsidered as the Phase 3 confirmatory trial to the Accelerated Approval product.