Friday, March 16, 2018 6:43:57 PM
I frankly don't believe the company was at all concerned with safety. An investor who visited the company in Israel had been permitted to try a little of the cream, no telling how many others were. The requirement to do the trial with healthy people was probably required by authorities in Israel, but perhaps the U.S. FDA was asked as well. Personally I believe the authorities add a great deal of cost and time for such trials, other companies are selling cream with cannabis in it, but probably not as high a content, but my point is authorities know this, what would the harm have been if they used patients with psoriasis or other skin diseases in the Phase 1 trial and then have a Phase 2 portion where added patients were dosed at what was determined to be the most effective dosing level. Had that been done, the next step could have been a Pivotal Trial if the outcome was sufficient to warrant it.
Gary
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