The meeting was held particularity to address topics central to definition of the applicable patient population and primary endpoint for the Phase 3 randomized controlled trial (RCT) of PV-10.
Provectus Pharma CEO Craig Dees said this meeting was extremely productive in defining the threshold the Agency will require for approval in oncology.
"Based on the recommendations of senior Agency officials during this meeting we plan to request a third end-of-Phase 2 meeting very soon to finalize our design since a much quicker iteration is now probable," Dees said.
"The input of the Agency will help us complete design of our study to meet current and likely future standards for approval."