$AGRX Remember: Agile PI was 5.83 total based on FDA’s interpretation but 5 as a reference point, had no basis by which to be extrapolated as the data pool excluded Obese women historically until such time that Agile performed the first “real” world clinical trial to include obese woman - SECURE Agile study 23 list 4.8 as the total which became a moment of confusion and worry for some bulls but the PI was disputed and debated at the Adcom and the FDA listened to reason. “You can’t compare Agile’s PI to CHC pills PI that did not include obese woman in the study.” Not apples to apples, and this was the theme. Agile is now the leading contraceptive company who, IMO will enter into post marketing studies with the FDA, in order to improve upon the outdated guidance given by the FDA regarding efficacy and effectiveness of contraceptives for woman of all “sizes and ethnicities.” Bullish
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