May 31, 2012

FDA Gives Guidance For Provectus To Move Forward With Phase 3 Clinical Trials of PV-10

The above headline comes from a PR Newswire piece that appears to have been produced in May by Provectus' PR/IR firm PLR. The audio can be heard here.

I did not see this until it got picked up by a Google filter of mine yesterday (the dateline of the piece was May 29). A friend of the blog said he saw this a couple of weeks ago, but I think he's wrong. It doesn't appear this "audio news release" was picked up in the same way as traditional PRs by financial or investment news websites and services.

May is Melanoma (Skin Cancer) Awareness Month. With a lead indication of metastatic melanoma, it makes sense for Provectus to put out a multi-media piece like this. Dr. Agarwala's quote is a good one. He seems almost downright giddy. Provectus, through this piece, is participating in the dialogue regarding melanoma awareness. Management wants PV-10 to be part of the solution and they're exercising their voice to do so.

Management's interaction with the FDA has been unusual in a good way. It would appear the back-and-forth between the parties is and has been very regular. This interaction is at odds with what others have experienced or suggest is usual.

It also would appear there are no more details regarding the trial design to be hammered out. None.

If that indeed is the case, then I can only assume FDA has agreed with Provectus on the SPA. That means management has their SPA.

Of course, until management has a formal communication from the FDA saying so, I could also view the situation quite practically as the FDA has not yet agreed with Provectus on the SPA.

I think management has their SPA. And as I recently posted, per management's guidance, it could (should) be formally announced in Q2 (best case) or Q3 (worst case).

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