Amarin Corp Plc (AMRN)

[Biobillionair]

Amarin has Not accepted a deal. The FDA has accepted the sNDA from 9-19-2013...this is prior to the Ad Com. We have no idea what this sNDA is. Amarin agreed to the 11-12 label change, 8.3...and that's it.

Vascepa's label HAS to be updated by December 9th, with the Acceptance of the 9-19 sNDA...those changes where enclosed in the 11-25 letter.

11-25-2013 FDA letter:

Amarin Pharma, Inc.
Attention: Peggy Berry
VP, Regulatory Affairs and Clinical Quality 1430 Route 206, Suite 200
Bedminster, NJ 07921

Dear Ms. Berry:
Please refer to your Supplemental New Drug Application (sNDA) dated and received September 19, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Vascepa (icosapent ethyl) Capsules.

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[This 9-19 supplemental approval" is the main topic of reference, the other dates and sNDA 9 label change (8.3) is just history. The new label 11-25....contains ONLY the changes Amarin accepted in the 11-4 communication from the FDA, and nothing in the 9-19 sNDA.]
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We acknowledge receipt of your email dated November 12, 2013, stating your agreement to the labeling revisions that we communicated to you by email on November 4, 2013.

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[We don't no what else the FDA requested, but Amarin ONLY agreed to change 8.3 and communicated it on 11-12 and posted those changes 11-25]
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This “Prior Approval” supplemental new drug application provides for the following revisions to the package insert, in response to our letter dated July 15, 2013:

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[FDA's pretending Oct 16th never happened, Instead skipped to communications prior to Ad Com.]
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“8.3 Nursing Mothers
Studies withomega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this excretion is unknown; caution should be exercised when Vascepa is administered to a nursing mother. An animal study in lactating rats given oral gavage 14C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.”

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[The above is the only change Amarin agreed to from the 11-4 communication. Changes from the 11-25 letter are still to be made and to refer to the 9-19-2013 sNDA.]
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APPROVAL & LABELING
We have completed our review of this supplemental application. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.

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[Certainly the FDA is not clear what they've approved, but at the beginning of the letter, "Please refer to your Supplemental New Drug Application (sNDA) dated and received September 19, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Vascepa (icosapent ethyl) Capsules", this supplemental approval refers to the sNDA from 9-19-2013]
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Content of Labeling:
-structured product labeling (SLP) & (CBE)
-Also within 14 days, amend all pending supplemental applications that includes labeling changes for this NDA, including CBE supplements for which FDA has not yet issued an action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this supplemental application, as well as annual reportable changes and annotate each change. To facilitate review of your submission, provide a highlighted or marked- up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy should provide appropriate annotations, including supplement number(s) and annual report date(s).

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[more changes within 14 days of this letter dated 11-25]
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PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory comments, (2) the proposed materials in draft or mock-up form with annotated references, and (3) the package insert(s) to:
Food and Drug Administration
Center for Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP) 5901-B Ammendale Road
Beltsville, MD 20705-1266
You must submit final promotional materials and package insert(s), accompanied by a Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html; instructions are provided on page 2 of the form. For more information about submission of promotional materials to the Office of Prescription Drug Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for

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[content labeling and promotional labeling doesn't make sense for just 8.3 change]
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I know this is HARD to follow and IMPOSSIBLE to believe, but the FDA just approved sNDA 5,6,7, or 8 whichever is the correct 9-19-2013 number. Only Amarin and the FDA know what the heck that is? Regardless, we should find out within the 14 day window. Check the label site daily. Nothing will ever justify the FDA's reckless mismanagement, and most investors will never recover their financial losses...