Amarin Corp Plc (AMRN)

[sts66]

Three months is the maximum extension that's allowed under current guidelines

FDA has repeatedly shown they can and will ignore guidelines (they're not legally binding) when it comes to AMRN. They'll delay as long as they damn well please and AMRN has no legal recourse. And I don't believe FDA can issue a CRL because the AGENCY has internal problems, i.e. organizing and staffing an AC - CRLs are issued for drug apps that are not approvable in their current state, and requires the whole sNDA process to start over again once the deficiencies are addressed.