Amarin Corp Plc (AMRN)

[MedResCollab]

Extension of PDUFA date?

There is another, related, possibility as to what is behind the silence on an AC meeting from FDA. They may be contemplating requesting, or have already requested, additional information from the sponsor, and would consider the submission of such information as a major amendment to the sNDA, thereby extending the PDUFA date. Such an extension is most commonly 3 months, though it could be longer in some instances.