Definitely more information flow during this resubmission period compared to the first 6 months.
Yep heart skipped a beat and it's like oh, not quite there yet, but if they've met so close to the decision date, how can they not have an agreed path forward?
Just over a week to go, nothing else we can do now. Here we go BOTers
Ann: Final Sofdra Labelling Discussions with FDA, page-5
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