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11/18/19 5:31 PM

#252141 RE: Sir Pumpernickel #252125

Sir Pumpernickel,

Based on comments from Linda they want buy in from all regulators with regard to the SAP. As far as approval, which happens later instead of simultaneously, they would by economic necessity move forward with any first approval but that first approval generally starts with FDA. Nothing is absolutely set in stone but history is on the side of this scenario as more likely than not. Best wishes.