Amarin Corp Plc (AMRN)

[Biobillionair]

FYI, I believe the FDA has reviewed the Anchor indication. If you read the Medical Review by Dr. Chowdhury the redacted b4 statements all fit.

Also review the last paragraph on pg 10 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
"The applicant was told prior to this NDA submission that data from Anchor trial would not be mentioned in the Vascepa labeling until, at a minimum, 50% enrollment of a cardiovascular outcomes trial was reached."

Anchor application accepted PR was 4-23, minus 4days with SEC reporting.
This coincides with the FDA 4-19 change, which I assumed was BASF approval.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist

I believe Anchor gets added to the label whenever Amarin wants to make the change. (Negotiate)

Read the document.
"This application also contained a study report, but not the dataset, for the ANCHOR trial. This trial was not considered pivotal to the efficacy claims of Vascepa for this NDA. The ANCHOR trial investigated patients with TG between 200 mg/dL and 499 mg/dL despite statin therapy. The applicant was told prior to this NDA submission that data from the ANCHOR trial would not be mentioned in the Vascepa labeling until, at a minimum, 50% enrollment of a cardiovascular outcomes trial was reached."

-Anchor gets added to the label any day
-sNDA official approval to follow at or before PDUFA

Can't believe I missed this paragraph;)

Williams