Provectus Pharmaceuticals Inc. Receives Guidance From FDA on Pathway to Approval for Phase 3 Trial of PV-10 For Metastatic Melanoma

KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has received guidance from the U.S. Food and Drug Administration ("FDA") to submit its Phase 3 protocol for review, either via standard review or a request for Special Protocol Assessment (“SPA”). This guidance was in response to Provectus’s request of a final end-of-Phase 2 meeting to achieve consensus on design of a planned pivotal Phase 3 randomized controlled trial ("RCT") of PV-10 for metastatic melanoma. The FDA indicated that an additional end-of-Phase 2 meeting with Provectus is not required.