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Re: None

Wednesday, 11/18/2015 9:32:15 AM

Wednesday, November 18, 2015 9:32:15 AM

Post# of 16885
Panel

Since the whole FDA review process is a mystery to me, I've been trying to educate myself. The put out a pretty good power point summary: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM218757.pdf

Since this is priority review and we are in Month 3, the FDA is required to decide in November whether a panel will be necessary and then communicate that to Braeburn. So if we haven't heard anything by the first week of December, I assume no panel.

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