Provectus Biopharmaceuticals Inc (PVCT)

[vorlon1966]

The answers I am about to give is the truth as I know it from being in conversations with mgt over the past five years.

I remember each and everyone of those FDA meetings about PIII trial designs. I remember when PVCT would have their meetings and comeback with word the FDA wanted something changed. I remember back then mgt saying that the FDA had a problem with this new type of drug and that the regular PIII trial design the FDA uses doesn't fit. I remember mgt saying it was a moving target to get them to nail down a design. I remember when they finally got some agreement made on the SPA/PIII (over two thousand page application) only to have them say the FDA said hold off and go the BTD route....It's new and shiny and fits your drug better. That December meeting I thought was the BTD meeting.....in a way it was. They went in with the MM indication just like what was in the PIII/SPA design. The FDA told them no....go for local regional control...an unmet indication. Go get the data in the subset group and see if it can pass on that. Now about that pain data......that was not required. If it was, then PVCT would have come out of that meeting and said short study to get pain and bleeding data. But during the BTD decision some at the FDA did not allow, obviously, the waiver the initial FDA group gave on that pain data.

Could they prove this? Yes and no.
The FDA does not allow recording of the meetings. You may only take notes. PVCT does have their notes but if they are released publically and the FDA gets embarrassed then you can kiss your application goodbye for the next five years.

Those that think the mgt is inept don't know the real story.
They did exactly what the FDA told them to do.