|[December 18, 2013]
Provectus Type C Meeting With FDA Oncology Division Held December 16, 2013
KNOXVILLE, Tenn. --(Business Wire)--
Provectus Pharmaceuticals, Inc. (OTCQB:PVCT) (http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company,
today announced that it held a Type C meeting with the FDA's Division of
Oncology Products 2 on December 16, 2013. The purpose of the meeting was
to determine which of the available paths that Provectus' novel oncology
drug PV-10 will take in pursuit of FDA approval and commercialization.
Under FDA rules, the agency should issue official minutes to the Company
within 30 days after such a meeting; in this case by January 15, 2014.
The minutes will clarify the available regulatory paths and, therefore,
allow the Company to better estimate a time-line to commercialization of
Chief Executive Officer Craig Dees, Ph.D., said, "This meeting with the
FDA is a significant step forward in establishing a pathway to initial
U.S. approval of PV-10 for the treatment of melanoma. There are
different possible routes to approval of PV-10 such as a breakthrough
therapy designation or accelerated approval and each of these has
different requirements and time lines. I appreciate that our
shareholders are eager to receive as much information as possible, and
while there is nothing more the Company can add until it has received
the official meeting minutes, we wanted to provide this interim update.
In addition, our discussions with several potential international
licensing partners are not affected in any way."
About Provectus Pharmaceuticals, Inc.
Provectus Pharmaceuticals specializes in developing oncology and
dermatology therapies. Its novel oncology drug PV-10 is designed to
selectively target and destroy cancer cells without harming surrounding
healthy tissue, significantly reducing potential for systemic side
effects. Its oncology focus is on melanoma, breast cancer and cancers of
the liver. The Company has received orphan drug designations from the
FDA for its melanoma and hepatocellular carcinoma indications. Its
dermatological drug PH-10 also targets abnormal or diseased cells, with
the current focus on psoriasis and atopic dermatitis. Provectus has
recently completed Phase 2 trials of PV-10 as a therapy for metastatic
melanoma, and of PH-10 as a topical treatment for atopic dermatitis and
psoriasis. Information about these and the Company's other clinical
trials can be found at the NIH registry, www.clinicaltrials.gov.
For additional information about Provectus please visit the Company's
website at www.pvct.com
or contact Porter, LeVay & Rose, Inc.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained
herein are subject to certain risks and uncertainties that could cause
actual results to differ materially from those reflected in the
forward-looking statements. Readers are cautioned not to place undue
reliance on these forward-looking statements, which reflect management's
analysis only as of the date hereof. The company undertakes no
obligation to publicly revise these forward-looking statements to
reflect events or circumstances that arise after the date thereof.
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