Topic: Panel Meeting Steps

Order Description Please prepare a slide deck showing the steps required to put together a panel meeting with timing. The timing should show how many months are required for each step. Please also show the overall timing needed from the start to finish. The start line is the time the PMA submission was sent to the FDA for review. The finish line has two items: (i) panel meeting and voting completion; and, (ii) expecting PMA approval date. For timing purposes, please assume the start is Jan 1, 2016 for PMA submission to FDA.