December 1, 2011

Words Have Meaning

I believe words are nothing more than vehicles for meaning. By writing this, I am referring to the company's press releases. In developing a relationship with the management team, I believe this is very much the case at Provectus: The words they write tell us things, meaningful things.

For example, the company clearly telegraphed, in my view, that they had a discernible or clear regulatory approval path in Australia. See here for the PR. The words that have meaning, to me, are:
  • "Use of interim data from the first half of Phase 3 study subjects, in conjunction with safety data collected in earlier studies of PV-10 for melanoma, was discussed to allow early evaluation for marketing approval for metastatic melanoma, and TGA agreed that these data should be sufficient for this review if the analysis confirmed efficacy."
Now, I don't know about you, but the PR's title of "Provectus Meets with the Therapeutic Goods Administration to Review Path for Approval of PV-10 in Australia" tells me there is an agreed upon path to approval. Read: Uncertainty lowered, and risk defined. You might say "bullpucky," and that is your right. But I will respond and say you're wrong. And therein is what makes a market: Two opposite views. If I'm right, you will buy at a [much] higher share price than the current 78 cents (last trade at 3:19 pm). If I'm wrong...but I'm not wrong, and the market will catch-up eventually.

This week's PR was entitled "Provectus Reports on Third End-of-Phase 2 Meeting with U.S. FDA to Define Pathway to Approval of PV-10 for Metastatic Melanoma." This tells me 

Recall two more situations in which words have meaning, which I previously have blogged on:
  • In this week's PR, "...melanoma, which is a rapidly evolving therapeutic area" means the FDA recognizes that the approvals of ipilimumab and vemurafenib address only part of the melanoma patient population and that other areas (i.e., the bulk of recurrent melanoma) still are unmet needs. There is much mainstream press on the "success" of ipilimumab and vemurafenib. Such success is superficial and fleeting. The FDA believes PV-10 has a much greater value proposition and much more applicability than these two compounds. Of course, there is a path to traverse.
  • If you recall the PR from the meetings management had with the TGA last year, the mention this week of a potential second MM phase 3 trial in Australia should be viewed, I believe, of the company simply saying that the Australians want to proceed now. The TGA wants this treatment made available to Australians as soon as possible. Of course, there is a path to traverse, again.
Industry insiders suggest SPA meetings with the FDA typically are conducted within 60 days after said meetings are requested of the agency (those same insiders also would suggest such meetings could occur as soon as 45 days after requesting them).

In Provectus' PR regarding the 2nd meeting, management wrote "...we plan to request a third end-of-Phase 2 meeting..." I asked management how long it took, for whatever reason, to request the 3rd meeting: approximately 60 days. I imagine one requests a meeting after one gets the meeting minutes back from the agency. That takes several weeks. so:
  • An early March meeting...
  • + 15-20 days to receive the minutes...
  • + 60 days to request a meeting...
  • + 60 days to get the meeting after one requests it...
  • = A July meeting.
Commissioner Hamburg's internal e-mail about the reorganization was sent on July 13th. Given an October 18th 3rd meeting, the reorganization, as I previously blogged, cost Provectus about 3 months.

In the company's PR regarding the 3rd meeting, management wrote "... we have requested a fourth end-of-Phase 2 meeting..." When did they request the meeting? How soon before the issuance of the press release, since I assume they requested the 4th meeting after they received the minutes from the 3rd meeting. Let's assume the minutes arrived anywhere from a few weeks before the PR to just before it, or mid- to- late-November.
  • Mid- to late-November when a meeting was requested...
  • + 60 days to get the meeting...
  • + Adjustments for the Christmas holiday season and New Years (say, a couple of weeks)...
  • = A February 2012 meeting at the latest, and perhaps as early as mid-January (based on the 45-day comment above).

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