Why? [Now] You Know Why.

Sometimes, it's what isn't said that may be as important or more so than what's said. Sometimes, it's not just how you say what you say, but how you say what you don't say.

We don't talk at all about serious adverse events ("SAEs") related to PV-10 trials and the compassionate use program ("CUP"). We rarely talk about AEs in general, aside from the mild to moderate ones experienced thus far in the trials and CUP.

Sometime between last year, sometime, and this year, sometime, Provectus arrived at an agreement with the FDA on a special protocol assessment ("SPA") for its pivotal metastatic melanoma ("MM") Phase 3 trial. How do I know? I don't. Do I know for sure? No. If one presumes or contends management is feckless or incompetent, then they're still working to convince the FDA that the local agent PV-10 has some sort of value, and wasting value cash in a pointless task. The SPA still is M.I.A.

I don't presume anything of the sort, even though there have been breadcrumbs of the SPA scattered among company communications and medical conference presentations, that tantalize us about parameters, timing, enrollment, etc. With each of these crumbs we thought the SPA and trial commencement are upon us, or within our grasp.

I think the breakthrough therapy designation ("BTD") arrived essentially in the middle of the process of management working towards the SPA with the Agency, "upsetting" the old SPA path and setting the company onto a new BTD one (whether in parallel, or as an extension). I'm guessing the supposed agreement was verbal in nature, proffered to Eric and his regulatory team, but set it aside in pursuit of an accelerated path to approval.

But, not everyone sang from the same hymn book. In hindsight, those "off key" notes were prescient.

It's not a bad thing the SPA up and vanished like a fart in the wind. It's the "good" option. It always has been. Interim Phase 3 results would provide Big Pharma with the traditional data they required to consider a worldwide license or acquisition of the company.

It might feel to some like we've been down this road before. High expectations: 2010. Accelerated approval. 2012. SPA. Today, nothing...yet.

Is this time different? Everyone seems to be singing from the same hymnal. Finally.

The current regulatory affairs narrative seems to have several facets to it:

• The company has filed its BTD application. Previously, there'd been, at times, an almost absurd did-they-file, did-they-not-file charade to the process.

• The company filed for BTD around October 1st, starting the/a so-called 60-day clock. Adding about 15 days because of the recent partial federal government shutdown (precisely, October 1-16), an expectation for communication from the FDA on this conceivably could come around or before mid-December. Since you never know about federal government mailrooms, and with business time inevitably slowing after Thanksgiving, it's conceivable Provectus, and thus we, don't hear until the end-of-December or January.

• The BTD process to date [sort of] works like this: Work with the FDA and their process, such as it is, get "pre-qualified," and you get BTD. 100% of the companies [purportedly] that worked with the Agency in such a fashion received the designation. Don't work with the FDA, don't follow their process, don't get pre-qualified, and you don't get BTD. 100% of the companies [purportedly] that did not work with the Agency in the required fashion did not receive the designation. Provectus worked with the FDA. So, they'll get BTD, right? BTD was the "better" option.

• They asked for a meeting with the FDA to discuss BTD, and how (how best?) to request accelerated approval ("AA") or outright approval ("OA") in this context. I don't believe management has any doubt, and if one of them has it's small or de minimis, that they've successfully demonstrated PV-10's clinical value proposition for MM Stage IIIb-IIIc patients refractory to prior treatments. AA/OA was the "best" option.

I said I wouldn't discuss the details of my call with Dr. Weber, but here's a small perspective of how he said what he said, and how he said what he didn't. I have no doubt he is very experienced talking to "outsiders" like me. Dr. Weber was generous with his time, and thoughtful in his answers. "Methought the professor dost protested too much."

The commercial validation narrative appears singular: Regional deals and the Big Pharma end-game follow regulatory clarity.

[Now] you know why.

Tipper: You know what? I can get a couple of my brother's loser ass friends to go over to Mason's apartment, knock on the door and when he opens it wham! They'll junk-punch him all up in his man business and he'll fall to the floor whaling and crying "why?" and then we'll say "you know why!" (What Happens In Vegas)