Replies to post #172232 on Amarin Corp Plc (AMRN)

[HDGabor]

c-

Meanwhile the latest IRP does not contain anything about approval, the latest available info (IRP 2018/12) is:

Assuming ordinary FDA review clock (too early to request acceleration); late’19 approval estimate

It is possible if the submission will be before the end of February. We will see: it is fall within "late in Q1" category or not.

We do not have an exact timing, just

As a result, submission of the sNDA is not anticipated until late in Q1 2019.

Furthermore, all of it about the PDUFA date only … FDA could act before or after the deadline.

Best,
G