I was well aware of that trial, the question is, why can't they do the same thing with current trials and put them in the clinical trials database. If they did, their trials would have much greater credibility.
The Phase 1 Trial escalated in healthy patients and determined it was safe, now they'll be doing somewhat the same thing with people who have psoriasis. It's a shame the first trial couldn't have been done with psoriasis patients, then we wouldn't need the first part of the trial you referenced earlier. The good news is that if they go to the blinded trial, it will be an admission that efficacy was seen as they escalated. Hopefully they can report that at the point where they initiate the blinded trial. Another real possibility is that the blinded trial is adequate to gain approval, or at least be expanded to do so. The FDA has been more open to such trials, but I believe they'd also be forced to expand the number of trial sites, and hopefully include one or more in the U.S.
Gary
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