$AGRX Please listen to the first 2 1/2 minutes of the last section of the Adcom webcast: collaboration.fda.gov/pr381... The FDA rep clearly states they cannot "require effectiveness." All this panic over the 5.8 requirement is crazy when it appears to be more of a guideline, and testimony seriously questioned the validity of that number in 2019 anyway. She later states if there is a contraindication in terms of safety, that is handled with a "POST-MARKET" study. I don't how many ways they have to explain to the bears that this product has met the requirements for FDA approval!!
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