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Tuesday, March 13, 2018 9:12:19 AM
"The agency requested further evidence that the product does not cause sensitization in humans. While we respectfully disagree that further evidence should be necessary, we are working with the agency to address their outstanding comments, and we have determined that the most expeditious path involves providing additional data."
If anyone happened to listen to the call Norchi discussed the fact that the molecules from AC% peptide are to large to be absorbed and this was proven in the animal models, hence the short trial on humans just to prove this to the FDA's satisfaction.
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