RE: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.
And the FDA's Accelerated Approval is based on the above, and further objective criteria of therapeutic durability/clinical benefit, evidence of sufficient patient enrollment into an FDA approved late-stage/confirmatory clinical trial, and proof of GMP manufacturing capability - and not necessarily on some obscure abborant exogenous influence, like some ever-present 'cats and dogs eating' DJT conspiracists have tried to suggest on this message board -
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.