Moxa,
Let's not go overboard on what's been claimed, the efficacy testing with the cream was not done in clinical trials, it was preclinical done with actual psoriasis on animals, or in a lab, but not with people that have psoriasis. The scheduled Phase 2 which will be done with patients with skin diseases, is scheduled for third quarter as I remember the schedule from their most recent presentation.
The trial which I'm surprised no one's speaking about is the one for fibromyalgia. According to the presentation this trial began last quarter, and will go Phase 2 in the second quarter. In that we've seen nothing about the trial other than it's with the tablet, which I presume is our sublingual tablet, I would assume it's established as a Phase 1/2 so when they say Phase 2 they're speaking of an approved progression in the same trial. If anyone has seen or heard any more information about this trial, I'd sure like to hear about it. Perhaps this will be the key to what the company is presenting at the Wall Street Conference. I believe this is the first use of the sublingual tablet in patients with a disease.
The psoriasis cream is to complete it's Phase 1 this quarter, but it's being done in healthy patients, first clinical trial with skin diseases is the Phase 2 I've referred to above. Note, I've said skin diseases, not psoriasis, because I don't know that other skin diseases will be added to the trial. Once again, investors haven't been shown the protocol for the trial which is being established with an IRB at this time I believe.
Something which may be possible out of all the Phase 2 trials that are being done with commercial grade material is and approval by someone. I can't say it's possible for the U.S. as I don't believe the trial is even in our clinical trials database, but I believe that in Israel, or other nations monitoring the trial, anything is possible if the approving authority is satisfied by what's presented to them.
I believe that a drug that was approved in Israel would probably be accepted in a Pivotal Trial here in the U.S. probably Phase 3, but possibly Phase 2, the primary difference being the size of the trial.
So much the company is doing is a mystery. More information is presented in their latest presentation than anything they've said in ages, and the timeline is more revealing than anything else in the presentation IMHO.
Gary
