Amarin Corp Plc (AMRN)

[Atom0aks]

Do you have an example of an AdCom that occurred after a PDUFA action date? My research has only shown extensions (see Xeris Pharmaceuticals, Acorda, and Sage Therapeutics), which is inline with FDA goals outlined here (https://www.fda.gov/media/99140/download). Keep in mind, the document may only outline goals and may not be SOP. I will concede, however, that an AdCom this late in the cycle is contrary to said goals of convening AC meetings 6 weeks prior to the PDUFA goal date for priority reviews.