Well, the panel will cast a vote, and "It was a negative vote by this committee in 2013 that lead to the FDA requesting a further study".
So safe to say if it gets knocked back at the meeting, that will be your 'final' decision. Might not necessarily be the same case in the event of approval, hence the risk skewed to the downside.
Ann: Quarterly Shareholder Update - March 2019, page-7
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