Amarin Corp Plc (AMRN)

[HDGabor]

Agree w u, that script is important, but reinstatment is also (my view: if the SPA will be reinstated by any level, the DMEP has to approve the ANCHOR - they do not have a choice)

The last PR was on 21 Jan (87 days ago). Based on the appeal process 27 days for Amarin's new appeal submission and FDA's answer. (27 = 87 - 30 (to inform AMRN about action) - 30 (give an answer after the action completed).

Unfortunatelly we don't know whan AMRN submitted the appeal to ODE-II, but let assume 7 days was enough for them.

It is also hard the estimate the time for FDA's action but if we assume that 30 days should be enough for any of them we "have to" see (within the next 10-14 days)
a.) decision
b.) explain the reasons for the delay
(btw: AMRN already had to received the interim response from FDA)

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM343101.pdf