Amarin Corp Plc (AMRN)

[HDGabor]

Based on FDA guidance ( http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM343101.pdf ) and if AMARIN submited the appeal to ODE-II before end of January (I guess yes) it will not a "simple" denial and FDA sent a response to AMARIN (grant a Type A meeting or interim response or explain the reasons for the delay).

Type A meeting: decision on the appeal within 60 calendar days from receipt of the appeal.

interim response: decision on the appeal within 60 + 15-21 (?) calendar days from receipt of the appeal. 15-21 days are necessary for
- additional clarifying information from the sponsor or
- meeting with the sponsor or
- limited discussion with one or more members of an advisory committee or internal or external experts or
- advisory committee review

delay: who knows, but they have to discuss it with AMARIN

Based on the exact submission date and the content of interim response the FDA should render a decision on the appeal between March 22/31 and April 14/22.

Any thought?