Amarin Corp Plc (AMRN)

[Biobillionair]

Good thought but...the FDA only mandates label changes for the below reasons I believe. Including Anchor is a marketing angle not a safety of efficasy issue.

The three reporting categories for changes to an approved application are defined in § 601.12: 1) those changes that have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product, which require submission of a supplement and approval by FDA prior to distribution of the product made using the change; 2) changes that have a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectivenessoftheproduct,whichrequiresubmissionofasupplementtoFDAatleast 30dayspriorto distribution of the product made using the change; and 3) changes that have minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product, which are to be described by the applicant in an annual report.

http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM170166.pdf

This particular guidance is for "biological", haven't found the small chemical but I'm sure it similar.

This is really starting to take shape in my opinion.