RE:FDA ready to review novel cancer vaccine Platform TechnologyIn late 2022, the FDA took steps to enable "platform" technologies in drug development to expedite approval of groundbreaking technologies like novel processing equipment, cell lines, scaffolding, and bioprocessing technologies.
In late 2023, ONCY took steps to scale-up is novel bioprocessing systems to address the need for the increased supply of pelareorep for the upcoming registration studies and Accelerated Approval in multiple Rare/Orphan designated cancers, in anticipation of the FDA's expedited reviews/approvals.