Provectus Pharmaceuticals Inc. Message Board

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Biotech / Medical : Provectus Pharmaceuticals Inc.

PVCT 0.0696

+1.6%

Nov 5 3:22 PM EST

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From: boomertree2	5/23/2014 5:19:53 PM
	Read Replies (2) of 13111

Get ready to be more pissed. The following link is to the FDA rejection letter: FDA's letter rejecting the BTD request for PV-10 is dated May 16, 2014. The letter is dated May 16 and Dees is reported in another blog site to have received it on May 21. Read the letter. It appears to be a reproach from the FDA that it gave continuous clear guidance to the company what it needed to provide in the BTD application, and the company failed to provide the information. The letter refers to FDA guidance as early as 2010, and as late as April 2014 after the BTD application was filed. The company either neglected to follow FDA guidance, or the data wasn't available because they failed to collect the data when the trial was conducted.....such as data on patient symptoms such as pain, bleeding, ulcerations, etc. At this point, a change of management may be the next step to regain market confidence in the future of the company.

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