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Provectus Should Have FDA Approval For Phase III, Why Adam Feurestein Is Wrong.

|Includes:Provectus Biopharmaceuticals, Inc. (PVCT)

There has been a lot of hype around Provectus (NYSEMKT:PVCT). The recent price action has been nothing short of spectacular in the past few days and weeks. In my opinion there is heavy manipulation occurring. Regardless, the stock should do well in 2014. An FDA approval should be coming to push the PV-10 trials for melanoma into phase III. If not, then a crime will be committed by the FDA.

Some pundits have graciously explained why Provectus PV-10 will fail. One of those pundits is Adam Feurestein (NYSE:AF). I am going to critique his recent article published on 1/23/14, an article with perfect timing for the bear raid (although the recent bull push was ridiculous, I think 2.00-2.50$ share is a good place to enter into PVCT. My critique will explain why every single one of his points in his article, except a few, are just plain wrong or simply opinion with no factual grounding.

In regards to why the company officials suddenly being quite: no one knows. Anything said is simply opinion. End of story.

Adam claims that PV-10 is simply diluted Rose Bengal, a stain used by eye doctors. It can be bought by the gallon easily and cheaply... this is true. But he implies that Provectus purification of Rose Bengal does not make it different.

First, I have a degree in chemistry. AF has a degree in political science. Let's just get that out of the way. I actually work in purification of specialty chemicals, and used to work as a chemist (contractor) at one of the best pharma companies in the world working on the manufacturing process of small molecule drugs.

I can tell you that purification can make a world of difference in the application and functionality of a compound. I am not familiar with the PV-10 manufacturing procedure, so I am speaking in general (but so is AF). Impurities can hinder the products full potential, whether it's a pharmaceutical or a polymer used in solar panel cells. In pharmaceuticals, impurities can interfere with surrounding tissues and molecules like enzymes, hindering the body's ability to absorb or utilize the compound. Secondly, impurities can be dangerous and the risk for potential side effects is greater. These are facts. Don't let AF's implied statement stray you from facts. It is cheap, and the only risk I see is the black market taking some sales away. Sometimes purification can be very expensive. I deal with this on a daily basis. I literally make 100% pure material sometimes (as measured by gas chromatography technique, nothing is ever truly 100% pure).

He also writes that few, if any people cared about PV-10 in the medical community. Again AF, this is not a fact, your opinion. End of story. He also writes Provectus has never got a partner, implying that no one respects PV-10. AF again implies, but shows no proof, except that management made promises. Well, there is still a lot time for a partner.

Another point he makes is that it has taken management a lot of time to get (not there yet) to Phase III trials. He's right, this is true. I will give him that. What this implies could be many things, but this is a legit concern. One of only a few he makes. He is right everyone should question this, but at this point it is still speculation as to why. I am interested in facts.

He also talks about the competition in the melanoma landscape. I agree things are looking to improve in this market from a patients perspective. Many competitors are out there. But he mentions Bristol Myers Squibb Yervoy, a compound with a 10.9% response rate( This is poor. In addition, the side effects of Yervoy are much more severe, with people actually dying from it. You can read more about the side effects in the Yervoy packaging insert. Just search for it, the side effects can be very bad including recorded deaths.

Guess what? Provectus PV-10 has a 51% response rate, and a very mild side effect profile to date. Were there deaths in PV-10 from hepatic failure like in Yervoy? No. PV-10(Rose Bengal) for melanoma has shown, so far, to be very well tolerated.

AF also mentions that because of the advances in melanoma, the FDA won't let PV-10 go to phase III. Adam, are you serious? You're trying to imply the FDA won't let this go to phase III because other companies are developing their own drugs? Are you serious? Please. This is another opinion from AF, and in fact, one of the most illogical opinions I have ever heard of.

But not as illogical as his comparison to Vicals Allovectin-7. He claims that because they are similar the FDA will not approve PV-10. No, Adam, you are wrong again. Such poor logic. Vicals Allovectin did not get approved because the phase III trials showed it had an 11% response rate and a Hazard ratio of 1. This means it's not effective at all. That's why Vicals Allovectin didn't get approved. Provectus PV-10 has shown a 51% response rate in Phase II with mild side effects. There is no reason why it should not get moved up to phase III.

AF claims Merck will get its Lambrolizumab approved after only phase I results. I am assuming he means to phase II, because it's not clear, but so what? How does this affect Pv-10? I love how he uses imagery like "standing room crowds" when writing about Lambrolizumab. So what? Again, how does this affect a phase III trial for PV-10? It doesn't.

PV-10 should be moved up to phase III. The FDA has no good reason not to. AF did make the case that there could be a lack of patients out there considering how many phase I, II, III trials are out there. This I do agree with, but it's a moot point. It would be crime to not let PV-10 move to the phase III trials. PV-10 has earned it.

Adam Feurestein, I'm calling you out. Explain yourself and your motives.

I am Long Provectus.

Disclosure: I am long PVCT.

Stocks: PVCT