Provectus Pharmaceuticals Inc. Message Board

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Biotech / Medical : Provectus Pharmaceuticals Inc.

PVCT 0.0640

0.0%

Nov 7 9:30 AM EST

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From: boomertree2	1/24/2014 12:42:16 PM
	Read Replies (3) of 13111

Press release disappointing. I expected an announcement of a clear path to FDA approval, which was clearly promised in the Company mid Dec Press Release. What we got was the Company submitting a request for breakthrough designation, and the FDA will act on the request within 60 days. More delays before any answers. Company must prepare data for BTD submission to FDA, and then we wait 60 more days for an FDA response. We already know from the missed 30 day scheduled posting of the type C meeting notes that the FDA promised deadlines aren't always met. Worst of all, there are no guaranties that the FDA will grant the BTD request. If they don't, then we are back to square one. If they do, that will be great, but we don't know what additional bridge studies will be part of the BTD designation. We were promised clarity from the publication of the type C meeting minutes, and we still don't have clarity. Clarity would have been the FDA granting BTD with abbreviated bridge study guidelines for a small patient population with short endpoints (tumor reduction or ablation). What we got was the filing of a BTD request, with an uncertain future as to acceptance or rejection of same. I feel mislead.

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