Replies to post #18101 on Amarin Corp Plc (AMRN)

[speedrunner]

Yes but it clearly states that the director must provide written documentation to the sponsor so that they can then request a meeting. My one concern is that whether FDA should have notified the company before the panel meeting or it can occur after the panel meeting. It would seem very unfair to spring this at the panel meeting so that the company is unprepared as it was in this case. IMO, it should have been done before the panel meeting. It may be possible that FDA can notify AMRN prior to the PDUFA date and then have a type A meeting with AMRN- this seems unfair as FDA panel was allowed to ruled on something that was not agreed to in SPA.