RE: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 - which is criteria that ONCY has met or will meet with its PR that their extended Phase2b->Phase3->Confirmatory trial has started - which is expected later this year or early next.
By this time ONCY will have either announced a partner and/or a Big Pharma acquirer, who will then register for an Accelerated Approval and run the confirmatory trial on their own time-line.
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.