I don't know when OWCP will announce anything, but suspect that year end results will be provided in an annual report by the end of March. Will we get anything before, your guess is as good as mine. The company said nothing, then suddenly we had patent approval, they say nothing, but things keep happening.
I suspect the next thing to happen may be the initiation of the Phase 2 Trial in psoriasis, and they may, or may not tell us about it. I do believe after a decision is made to go into the blinded portion of the trial they'll tell us so. Remember the first part of the trial is intended to determine the best does to use in the blinded trial, and in that they see the results, I'm hoping we will as well.
There are people who create doubt because things like Phase 1 trial results are not presented for peer review, check other companies, I believe you'll find that's the case with nearly all of them. The fact that safety is established in Phase 1 is clear because Phase 2 is being initiated. In our case, the Phase 1 was done in healthy people, so no indication of efficacy was possible, the cream is safe, no peer review required.
I suspect that if the work the company has done were being done here in the U.S. the cost would probably be ten times or more than what's been spent, or is needed to complete Phase 2's. It's not impossible to gain approval in Phase 2, at least for a limited number of countries. I suspect the U.S. would insist on a Phase 3 with at least some trial sites being here in the U.S., the cost will be far higher, and they'll probably need a partner before they can do it unless they do have approvals in at least a few countries generating the funds necessary to do it.
Much the same will be true for the sublingual tablet, etc. IMHO they don't proceed until patent approval is established.
Gary
