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Re: Arbo71 post# 1195

Wednesday, 01/15/2014 5:41:09 PM

Wednesday, January 15, 2014 5:41:09 PM

Post# of 9947
It sounds like PVCT provided some additional information to the FDA which may have resulted in that "30 day" response requirement being pushed out a bit. That last sentence is particularly interesting.

From the 8K...

"Reference is made to Item 7.01 of the Current Report on Form 8-K of Provectus Biopharmaceuticals, Inc. (formerly Provectus Pharmaceuticals, Inc.) (the “Company”) dated December 18, 2013 and filed with the Commission on December 18, 2013, which is incorporated herein by this reference, announcing that the Company held a Type C meeting with the FDA Division of Oncology Products 2 on December 16, 2013 to discuss the Company’s oncology drug, PV-10.

Subsequently, the Company took the opportunity to provide input into the documentation of meeting minute notes. It is the opinion of the Company that this may have delayed the process of receiving the final meeting minute notes. Therefore, the Company will communicate further guidance from the FDA once the meeting minute notes have been received, which is expected shortly.

It is also the Company's opinion that the delay has no bearing on the FDA's decision regarding the efficacy of PV-10 but is rather a matter of observing governmental processes. This delay also has no bearing on the Company's discussions and negotiations with parties outside the FDA's jurisdiction."

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