Provectus Biopharmaceuticals Inc (PVCT)

[vorlon1966]

I have been through all of this with Miller Energy stock.
Hit piece, heavy shorting and baseless lawsuits.
Their stock dropped like a brick and recovered.
Lawsuits eventually went away.
I am not concerned one bit.

Everyone is pissed at the low pps.....I understand.
Everyone wants to blame somebody....common reaction.

It is still my firm belief that the FDA was guiding them all along but at the final decision some at the FDA thought it unwise to approve without the PIB data because that sets a precedent of approval with waiver on PIB. I don't like that but I can see their point. Every Tom, Dick and Harry pharma would now be asking for the same waivers. Prior pharma BTD's would be pissed they had to go through all the steps.

I have been following the company for five or six years. I remember each and every time mgt met with the FDA trying to lock in a PIII trial design. I remember that the FDA kept changing what they were asking for and the problems of PVCT being asked to put a square peg through a round hole. Recist protocols and the statistical analysis that goes with it has an inherit problem. How do you measure progression in a lesion that ablates in a day? How do you measure pain when none exists? The equations cannot take a zero input. How do you do a true double arm-double blind study? There is no approved intralesional therapy as a true comparator....the drug is not a systemic drug when you are looking at ablation....there is no red injectible drug so the blind part of the study is meaningless. Everything about running a PIII with pv-10 is a compromise on protocols. And way back then the FDA would not move.

So for all of you who wish to complain that mgt is inept at running trials have no clue what you are talking about.

Moving forward...the PIII will be run...albeit a compromise on comparator protocols....something I expect they will workout with the FDA now that they have more interaction with them now. I am waiting to hear more details.

Money? There are enough warrants out there not converted yet to put two or three more quarters of cash in the bank. There is still the fabled China/India licensing deals in play which I now think it's finally at the end. I know its been over a year of this talk but I think the company is close to getting a MOU. If that happens then more than enough money should come in as upfront fees to run a few PIII studies in my opinion. If they close....and I say "IF"...then they will run their own studies in their own countries which will go faster than the one here. And "IF" that happens then you are going to see big income from sales.

Another forward thinking statement......historically small pharmas get gobbled up when the mid point study data is out. The company has enough money right now to get to that point.

These are my opinions based upon my DD. Everyone else do their own.

I plan on increasing my position as disposable income allows.
Why? Because now the PIII study will be able to treat all lesions as many times as it takes to make the tumor go away....and what do you think that data will look like?