Provectus Reports on Second End of Phase 2 Meeting with FDA to define Pathway to Licensure of PV-10 for metastatic melanoma
Craig Dees, Ph.D., CEO of Provectus said: “This meeting was extremely productive in defining the threshold of the agency requires for approval in oncology. Based on the recommendations of senior officials of the Agency at this meeting we propose to seek an end of phase 2 third meeting soon to finalize our project, because a much faster iteration is now probable. We expect this next meeting will provide the remaining bases to enable us to reach a consensus on a suitable model for the evaluation the special protocol (SPA). The goal of APS is the final result for the agency and society. “Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development stage oncology and dermatology biopharmaceutical company, held its second end of phase 2 meeting with the Food and Drug Administration (FDA). The meeting, held earlier this month, addressed several issues central to the definition of the patient population and in the applicable program’s primary endpoint of the Phase 3 pivotal trial (RCTs) of PV-10 for metastatic disease. Provectus seek a consensus on the design of the study to support approval of PV-10 for its melanoma indication.
Dr. Dees concluded: “We are also considering whether a second Phase 3 RCT, designed to meet regulatory requirements in Australia, it would be useful to accelerate the adoption of this important market. We are pleased that our capital resources afford flexibility to optimize our development plan to maximize the likelihood of approval in melanoma single major markets in the United States, Australia and the EU. “
