with this early discussions it helps them be more confident with the process.
once all prep work is done.
submit and FDA review: 90 work days to review and make decision. (clock stops when they request more info)
If FDA request more information you could see an additional 3 - 6 months.
as they are engaging FDA early I would say it will be closer to 90 work days.
Ann: Cleo Commences US Regulatory Process with FDA, page-18
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