Maxim Group's Dr. Yale Jen issued an equity research update on the company today. He anticipates Provectus would gain the SPA from the FDA in mid- to 3Q 2012, with the pivotal trial start afterwards (3Q12). Without the need for a 4th EOP2 meeting, this outcome was a positive surprise.
I think Dr. Jen is being very conservative in his time line for Provectus gaining the SPA.
Let assume the company submits the final protocol, for the sake of argument but illustrative of "as soon as possible," on Monday, January 23rd. 45 days from then (thus, assuming no further iteration with the FDA) is March 8th (I think). More generally speaking, early- to mid-March, or late-Q1. This is not mid-2012 or Q3. My early expectation is one to one-and-a-half calendar quarters (3-4 months, at least) sooner than Jen. It doesn't matter if my time line slips (it is bounded by Jen's); however, it helps for preparation not to be surprised if management secures the designation sooner than the crowd expects it (like Provectus not requiring a 4th EOP2 meeting).
A late-Q1 official receipt of the SPA also potentially pushes up the start of the pivotal MM P3 trial. Jen estimates a Q3 start. I project Q2, at the earliest.