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Replies to post #9291 on Provectus Biopharmaceuticals Inc (PVCT)
Mokyo Toe
12/06/17 9:00 PM
#9292 RE: Work Harder #9291
Pivotal melanoma Phase 3 trial of PV-10. Provectus' CTO Dr. Eric Wachter, PhD noted a 6-month delay: "I must unfortunately report that we are behind with regard to our initial schedule for reaching the interim and final analysis triggers for the study. I’m confident that we are implementing the proper study to support licensure of PV-10, but our present estimate that we are approximately six months behind schedule with regard to site start-up, patient recruitment and eventual data read-out." Prior guidance had been an estimated primary completion date (per ClinicalTrials.gov) of September 2017, and an interim assessment of safety and efficacy of June 2016 (halfway between an April 2015 study start date and the estimated completion date). Adding six months, purely on the basis of math, would push the interim and complete data read-outs to December 2016 and February 2018, respectively.