RE:FDA guides on how AA can be converted to full approval.Recent ONCY developments pursuant to the following March 2023 FDA guidance has moved the goal posts closer to ONCY's acquisition, given that Big Pharma is now more inclined to want to take a product from an accelerated approval through to a full approval to assure that the trial is appropriately designed and executed.
March 24, 2023 "While Congress recently passed legislation (IRA) that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval."
But the design of that trial must be precise as FDA says in today’s draft guidance that it must be “powered for the longer-term clinical endpoint with follow-up in the same trial to verify clinical benefit,” and should ensure that the accelerated nod doesn’t inadvertently introduce bias.
As far as logistics, the draft notes, “The trial sample size should be chosen so that it has adequate power to detect a clinically meaningful and statistically significant improvement in both the endpoints for accelerated approval (e.g., response rate) and verification of clinical benefit (e.g., PFS or OS).”
[ONCY is likely in talks with the FDA and Big Pharm potential acquirers on how to design 2 Phase 3 clinical trials to obtain both an accelerated aprroval AND a FULL approval - in both breast and pancreatic cancers]
https://endpts.com/fda-spells-out-how-cancer-drug-developers-can-use-one-trial-for-both-accelerated-and-full-approvals/