Amarin Corp Plc (AMRN)

[OldYeller187]

Vascepa marketing applications for US and EU

Just fired this off to IR. IR response is below original e-mail.

Dear Elisabeth,

I had a question I was hoping you could provide some insight into, regarding Vascepa marketing applications in US and EU.

I know much of the focus is on the US sNDA, but has Amarin considered doing simultaneous marketing applications (i.e within weeks of one another) to both FDA and EMA?

This is common practice for many sponsors, as much of the EU MAA dossier can be re-purposed or "cloned" from the US dossier, which lowers the operational burden. The US dossier tends to be more rigorous to build, as FDA requires full case report forms (CRFs) and datasets, whereas EMA does not require this for MAA.

It would be great to hear if Amarin is considering this as part of their regulatory strategy. Many thanks for any color you can provide in regards to this.

Regards,
Eric

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Hi Eric- You clearly know much about this process.



We are determining now if we want to start the European process with a partner, or file first then partner. There is not much other information I can provide at the moment.



Thank you for sharing your knowledge.



Elisabeth