Replies to post #4035 on Amarin Corp Plc (AMRN)

[Biobillionair]

Bravo
Let me make it crystal clear I have no guess as to when "the" decision will be made. We can see that over the past 3 months the FDA has posted numerous MAPP documents that relate to difficult decisions being made to best match historical decisions while also providing wiggle room for exceptions.

MAPP documents have an effective date, all that are posted now are effective at the date of posting.

Here's the link: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm

If both the generic guidelines for Icosapent Ethyl and Omega 3 Ethyl Esters used the same vocabulary my opinion would be the FDA is leaning towards rejecting 5 yr exclusivity. Clearly this is NOT what the USP and FDA have done in both the BE documents and MAPP 5021.1. This Manual of Policies and Procedures on pg. 9 changes the guidelines related to "an active moiety so that it will no longer include "esters"..." We all have to look at the facts and draw our own conclusions.

Hope this helps...