Amarin Corp Plc (AMRN)

[HDGabor]

BB-

Not exactly.

successful submission of a clinical trial application with respect to the MARINE indication for Vascepa to the Chinese regulatory authority in March 2016

Yes, so in China Eddingpharm with our support has completed all the filings needed to make request of China FDA as defined in the regulatory path going forward. We and they are anxious to get response from China FDA. One of the reasons we went with Eddingpharm was their record and experience relative to working products through the regulatory approval process in China. That being said, it's still maybe a bit of time before we hear back from China FDA. There are backlogs at China FDA which have been publicized that they're trying to shorten but nonetheless those backlogs exist.
Once we do hear back from China FDA, it's anticipated that we'll have to fund it by Eddingpharm, conduct some study in China, probably study somewhat analogous to what we did with the MARINE and ANCHOR studies here in the U.S. which as a reminder, were studies that from start to finish were about a year in duration. We don’t have those answers yet from China FDA. When we do have greater clarity there, we'll let folks know. That being said, all the information is in and we're -- we think China FDA has what they need to get back. it's just a matter of waiting.

- it sounds like: it will be MARINE only
- most likely scenario: conduct some study in China ... if we / Amarin will be lucky, CFDA won't require it - since it is about lipid lowering - and will approve MARINE (... and (???) ANCHOR)

Best,
G