For me it sounds they weren't in discussions at all, because surely this would have been addressed in the last 6 months of supposed discussions.
Resubmission of 3 to 6 months. Wow, the wheels of bureaucracy do turn slow.
Wont be able to attend the zoom as I'm away on holidays, so I hope we get some answers and gets posted online quickly afterwards so I can watch.
Ann: FDA Letter Requires Patient Instruction Update, page-38
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