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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.0685-2.1%3:39 PM EST
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To: Mark Buczynski who wrote (12940)6/6/2014 5:34:51 AM
From: Stuki1 Recommendation

Recommended By
travisnye

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Thanks Mark and thanks Howard.

Indeed- the drug review is treated as if it is some kind of game rather than
a situation where real people are suffering and dying. PV 10 has a fairly long history of use with little
or no adverse side effects ever mentioned while inducing rather rare cr rates and bystander effects. That the FDA did not make things crystal clear that they wanted a formal pain study and some more right from the start
strikes me as some thing fishy. A pain study is not a difficult concept to convey so some thing does not sit right with me that the FDA did not make this clear from the start or that PVCT/Dees and company would think they could get around not doing such a study, it if it was made clear. But the latter scenario seems too foolish to me to be the case.

In all the use of PV 10 both in the USA and Australia there was no talk ever of
added pain or increased pain. If I remember correctly going back years ago in the Australian studies there was some mention of sensitivity to the sun that went away in a week or so and maybe some swelling at the place of injection- that was it. In the Moffit studies there was no mention of adverse side effects.

But if the FDA was really interested in suffering patients they could
easily have questioned the doctors running the tests about adverse side effects. Since there is no history of adverse side effects after many years of use some thing less than double blind tests could at least temporary suffice.
After all, if some adverse effects did arise with wide spread use after granting BTD designation then use could be stopped.

I find it troubling that ordinary people suffer and die unnecessarily, not to mention the anguish this causes their families and friends.

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