Monday, March 27, 2017 9:33:48 PM
Their is another trial that has FDA concurrence, it's only for safety and is being run with healthy patients to validate the fact that their are no safety concerns. I believe it should be concluded in the second quarter.
It's my belief that the FDA insisted on this trial before they'd permit the cream to be sold in the U.S. as a cosmetic. Clearly the efficacy trial should also have demonstrated safety, but the FDA IMHO wanted to show that they had a hand in this, so they demanded the additional safety trials.
I'm frankly taking others words on the fact that Israeli efficacy trials are accepted in much of the world. I'm unclear whether in Israel and elsewhere the cream will be sold as a cosmetic, or a drug. Time will tell.
Gary
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