Timeframe is mid 2024.. so not a quick in and out fix..
But in the quantum of the application the jury is out and the Science is positive and approved..
Botanix will meet with FDA and undertake the minor activities and plans to resubmit the NDA by early
Q1 CY2024, with a target approval of mid-CY2024
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- Ann: FDA Letter Requires Patient Instruction Update
Ann: FDA Letter Requires Patient Instruction Update, page-68
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