Provectus Biopharmaceuticals Inc (PVCT)

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Audit to Encompass Regulatory Documents for PH-10 and PV-10
KNOXVILLE, Tenn.--(BUSINESS WIRE)--October 14, 2014--

Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company ("Provectus"), announced today that it has retained INC Research, a leading, global Phase I to IV contract research organization, to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV-10.

The audit will be conducted in two phases, both of which are expected to be completed by early November 2014. In the first phase, INC Research Quality and Compliance Consulting will undertake a regulatory document inventory and evaluation of the contents of Provectus' information management system (the Smart Room). The results of this phase will generate a document request list, and the second phase of the audit will involve further evaluation of the requested documents. This will entail onsite verification of the regulatory documents and a final analysis of diligence issues identified in the audit.

The audit will not touch on assessing information and relevant documents specific to marketing applications, marketing and promotion activities, nor will it address nonclinical and clinical data supporting final reports.

Dr. Craig Dees, PhD, CEO of Provectus, said, "Provectus is pleased to be working with INC Research Quality and Compliance Consulting in conducting this audit. By retaining their services, we are endeavoring to ensure that the upcoming phase 3 trial for PV-10 as a treatment for melanoma as well as the future tests of both PV-10 for other indications and for PH-10 to treat dermatological diseases proceed with all possible speed. Making sure that all the paperwork is available and in good order will smooth out the process."

About INC Research

INC Research is a leading global contract research organization (CRO) providing the full range of Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industry. Leveraging the breadth of its service offerings and the depth of its therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market. INC Research was ranked "Top CRO to Work With" by sites worldwide in the 2013 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, NC, with operations across six continents and experience spanning more than 100 countries.