They are hinting with the wording that they've done enough pre submission work to get a quicker response. That's how I read it anyway. I've posted previously that around 56% get a response within the 150 days. The average is 300 days but some have had a 90 day turnaround. It's out of paincheks hands now. Lots to look forward to with Scotland Wales and England approaching a decision. Hopefully end of March FDA decision. GLTAH that stuck around.
Ann: PCK submits application for Adult App FDA De Novo clearance, page-6
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