Something I mentioned on the other board that shou
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Posted On: 02/14/2018 9:09:40 PM
Something I mentioned on the other board that should be considered here. If the fibromyalgia trial began on schedule in the fourth quarter of last year, and if it's not a blinded trial, the company should be able to discuss results to date.
Of course we know nothing about the structure of that trial, that could certainly be revealed at the conference, whether it's blinded or not, but if it's not, and if it's being done with patients that have the disease, we could have substantial evidence of efficacy, as well as safety by now.
I'm not a big believer in Phase 1 Trials that are blinded, or that have a control group. Such trials may be needed in late stage trials, but why in Phase 1 where you're trying to determine safety, the most effective dose, and hope to see efficacy. I really see no value and would only do it that way if the regulators insisted that it must be.
Gary
Of course we know nothing about the structure of that trial, that could certainly be revealed at the conference, whether it's blinded or not, but if it's not, and if it's being done with patients that have the disease, we could have substantial evidence of efficacy, as well as safety by now.
I'm not a big believer in Phase 1 Trials that are blinded, or that have a control group. Such trials may be needed in late stage trials, but why in Phase 1 where you're trying to determine safety, the most effective dose, and hope to see efficacy. I really see no value and would only do it that way if the regulators insisted that it must be.
Gary
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