Amarin Corp Plc (AMRN)

[MedResCollab]

HDGabor,

One more comment, couldn’t resist—the parenthetical only applies to when a sponsor of an application designated Standard Review is notified (in/as part of the Filing Communication). It does mean, as you infer, that the Filing Communication is sent on day 60 to sponsors of an application granted Priority Review.

It is your reading of guidance, without experience, and is incorrect.

Don’t take our word for it—ask someone on a review team at FDA if the Filing Communication letter (aka “day-74 letter”) is sent to applicants on day 60 for P apps and day 74 for S apps, and see what they say.

Good luck to you.