Provectus Reports on Second End-of-Phase 2 Meeting with U.S. FDA to Define Pathway to Licensure of PV-10 for Metastatic Melanoma
News Mar 15, 2011
Provectus is seeking consensus on design of the study to support licensure of PV-10 for its melanoma indication.
Craig Dees, Ph.D., CEO of Provectus 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. We expect this next meeting will provide the remaining groundwork to allow us to reach a consensus on a design suitable for Special Protocol Assessment (SPA). The SPA objective is the expected ultimate outcome for both the Agency and the Company. The input of the Agency will help us complete design of our study to meet current and likely future standards for approval.”
Dr. Dees concluded, “We are also assessing whether a second Phase 3 RCT, tailored to meet the regulatory requirements of Australia, would be helpful in accelerating approval in that important market. We are fortunate that our capital resources afford flexibility in optimizing our development plan to maximize likelihood of approval in the unique, major melanoma markets in the U.S., Australia and the EU.”
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