Provectus Biopharmaceuticals Inc (PVCT): NEW CTD 10/14/2014 INC Research P...

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Provectus Biopharmaceuticals Inc (PVCT)

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Tuesday, 10/14/2014 6:22:02 PM

Tuesday, October 14, 2014 6:22:02 PM

NEW CTD 10/14/2014

INC Research

Provectus issued a press release and made an associated SEC 8-K filing today related to establishing a contractual relationship with INC Research, a contract research organization ("CRO") to conduct an FDA due diligence audit of Provectus' regulatory documents for PH-10 and PV-10. This kind of audit, and the larger relationship with INC, would, among other things, (i) assist institutional review boards ("IRBs") and principal investigators at clinical trial sites to follow the protocol of the upcoming pivotal Phase 3 trial for unresectable locally advanced cutaneous melanoma "to the letter," (ii) prepare for a new drug application filing, and (iii) facilitate the due diligence process of a license and/or or M&A transaction. In addition, employing an organization like INC places a supportive, accountable and expandable resource framework around Eric, who is responsible for Provectus' clinical development program.

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