The part 2 of Phase 1 is still being done with hea
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Posted On: 10/24/2018 12:44:48 PM
The part 2 of Phase 1 is still being done with healthy people, I think it could provide a small boost, but what we really need is efficacy in anything, psoriasis, fibromyalgia, etc. I don't believe that safety is a serious concern, and I wish the regulators would have permitted people with diseases to try the products in Phase 1. That wasn't the case in psoriasis, but at this point we don't know about all the other planned trials.
Sadly, I'll once again indicate that we could know, all the company would need to do is put the trials in the clinical trials database. It's clear they could do it, they did it for the psoriasis cream trial, but never modified it so what's there is completely wrong.
Phase 1 Trials are normally dose escalation trials, this is the first I've seen with two parts, most just keep escalating until MTD is determined, or at least until they've determined that higher doses are becoming less effective without actually having adverse effects. I cannot say how much of this was established by Israeli authorities, or the IRB, or if the company themselves designed the trial this way.
Phase 2 is certainly a trial that will be looking at efficacy, I frankly hope it's run unblinded so from the beginning they can discuss how the trial is going, but I suspect it will be blinded and we'll hear nothing officially until some predetermined number of patients have been dosed for some period of time.
Gary
Sadly, I'll once again indicate that we could know, all the company would need to do is put the trials in the clinical trials database. It's clear they could do it, they did it for the psoriasis cream trial, but never modified it so what's there is completely wrong.
Phase 1 Trials are normally dose escalation trials, this is the first I've seen with two parts, most just keep escalating until MTD is determined, or at least until they've determined that higher doses are becoming less effective without actually having adverse effects. I cannot say how much of this was established by Israeli authorities, or the IRB, or if the company themselves designed the trial this way.
Phase 2 is certainly a trial that will be looking at efficacy, I frankly hope it's run unblinded so from the beginning they can discuss how the trial is going, but I suspect it will be blinded and we'll hear nothing officially until some predetermined number of patients have been dosed for some period of time.
Gary
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