Amarin Corp Plc (AMRN)

[HDGabor]

S-

"The regulation does provide for an exception under limited circumstances" refers to a (final) approval (date).

"Some requirements that may remain after the FDA sends such a letter are ministerial and do not affect the finality of that approval. In those circumstances—including when the manufacturer will have to finalize a label to reflect DEA scheduling—the FDA does not need to consider further any aspect of the NDA and so it treats its “approval” as final."

- FDA did not include any requirement in the approval letter
- exclusivity determination (NME / NCE / no det.) does not effect the approval and / or label

Date of approval means the date on the letter from FDA stating that the new drug application is approved, whether or not final printed labeling or other materials must yet be submitted as long as approval of such labeling or materials is not expressly required. "Date of approval" refers only to a final approval and not to a tentative approval that may become effective at a later date.

FDA issued a final approval on July 26, 2012.

"Determination of whether this application qualifies for 3 or 5 years of exclusivity was not finalized by the goal date. The final decision will be made post-approval" post-approval = after approval -> V was approved. The start date of the exclusivity is the date of the aproval and isn't the date of the determination.

I think a lot of respected posters covered / check all aspect (btw: it is not a complex issue) and no realistic, legal scenario exist other than: NCE - 7/26/2012 - 7/25/2017

Best,
G