im·mi·nent

im·mi·nent
adjective
1. likely to occur at any moment
2. about to happen, occur, or take place very soon

Words have meaning.

A friend of this blog and large investor called me early this morning. We discussed OMP's research note. In particular, we wondered, together, why OMP would use the word "imminent," or a derivative of it frequently and where it did. "Imminent" has a distinctly different meaning for timeframe than Dr. Jen's comments, for example, of 1Q12 or 1H12.

The author(s) of the note likely made use of this verbiage because of their discussions with Provectus. While OMP could have mis-stated managements comments, guidance or expectations, this research piece has a different flavor to it:

• "Now in final stages of their discussions with the FDA, company management could announce a phase III program imminently. Because melanoma is a cancer type where drug development has been historically tricky, pharma interest maybe high with suitors lurking around to assess the complexity and feasibility of an FDA endorsed phase III design before pulling the trigger to in-license PV-10 or acquire PVCT." -- This is a very agressive call on the MM Phase 3 trial design decision by OMP, compared to Maxim's Dr. Jen. That said, it does imply having an impact, time-wise, on an in-license or acquisition (note: I don't believe there will be any qualms regarding the complexity or feasibility of an eventual Phase 3 trial, given the information available on the contemplated design).

• "In parallel, PVCT is negotiating with multiple companies to out-license their early stage phase I drug PH-10 (Rose Bengal 0.01%) for psoriasis and atopic dermatitis (AD). This is a more imminent but a smaller royalty deal, but since the dermatology marketplace has a backlog of ~10MM under-served patients in the US alone even a small percentage royalty may imply significant revenues for PVCT." -- More imminent [than an in-license of PV-10 or acquisition of Provectus] (n.b. comparative)? A dermatology deal has long been thought of as happening before an oncology deal, either a mini- or complete one. While the announcement of an FDA-endorsed Phase 3 trial starts the beginning of the end-game, prospective licensees need to see the long-awaited psoriasis Phase 2 c data, which likely begins once management releases the efficacy results via a PR.

• "With a cash position of $14.4MM and three large pivotal trials in the design stage (MM, phase 2/3 in HCC versus sorafenib and psoriasis), it seems logical that PVCT will require additional capital imminently, yet management insists that they are well capitalized thru YE2013." -- The company surely will require capital imminently for these three pivotal trials if they start them imminently. At the same time, they can readily and imminently access capital (through the LOE and/or shelf filings) if the strategy and rationale of doing so for one or more of the three trials is justified, vis a vis both imminent and long-term valuation. Did I use "imminent" enough?!