The FDA turned down Provectus BioPharmaceuticals' (PVCT) request to grant Breakthrough Therapy Designation (BTD) to its experimental skin cancer drug PV-10.
Of course. I told you this BTD rejection was going to happen last January. Being right about the obsolescence of PV-10 doesn't make me especially prescient, it just means I'm sane.
Here's the key line from the letter sent to Provectus by the FDA. Please, everyone, pay attention:
FDA previously communicated concerns regarding the development program and provided advice regarding the type of data that should be systematically collected to investigate the clinical benefit(s) of an intratumoral treatment of a subset of individual lesions in a systemic disease (malignant melanoma), as previously discussed at the April 8, 2010, March 7, 2011, and October 18, 2011, end-of-Phase 2 meetings and the December 16, 2013 General Guidance teleconference.
Understand? Provectus and the FDA have been meeting over the same PV-10 phase II data FOR FOUR YEARS! The FDA has already told Provectus repeatedly: If you want to compile the data necessary to file PV-10 for approval, please run a phase III study. But Provectus is incapable or unwilling to listen the FDA's advice. The company would rather issue misleading press releases and hoodwink ignorant retail investors into buying its stock -- and losing money.
Here's some advice for Provectus CEO Craig Dees: Do the phase III study FDA told you to run four years ago. Until then, shut up.
Oh, by the way, the FDA's letter rejecting the BTD request for PV-10 is dated May 16, 2014.