Human factors is just a study on the ability for people to understand the labels and instructions, application of product etc. this passed with flying colours. Additionally, BOT consulted with FDA on this beforehand so likely just did what the FDA said with regards to labels and instructions. At this point it’s just a cross check tick box activity for the FDA. A potential 2 month review of the resubmission has not been mentioned before which leads me to believe we’ll see an approval and launch in March 24. Just in time for those sweaty summer days. Merry Christmas y’all
Ann: Botanix Resubmission of NDA for Sofdra Completed, page-44
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