Provectus Biopharmaceuticals Inc. Reaffirms Its Commitment To Bringing PV-10 To Market Notwithstanding FDA Decision On Breakthrough Therapy Designation
5/27/2014 8:28:12 AM
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has received notification from the United States Food and Drug Administration that the data upon which the Company based its request for designation of PV-10 as a Breakthrough Therapy for the treatment of patients with locally advanced cutaneous melanoma was insufficient to demonstrate substantial improvement over existing therapies. As a result, the FDA has declined to designate PV-10 as a Breakthrough Therapy at this time. Further data may cause the Agency to revisit this decision at a later date. PV-10 is the Company’s novel investigational drug for solid tumors.
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