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OldYeller187

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OldYeller187

Re: circuitcity post# 168004

Wednesday, 12/19/2018 5:55:20 PM

Wednesday, December 19, 2018 5:55:20 PM

Post# of 448124
US and EU are closely harmonized in terms of their requirements, so no additional study is needed in EU. China is different though. In addition to R-IT, Amarin needs a China specific study to show the drug is safe and effective in Chinese population. I assume this is the study that began in Jan 2018.

After that study concludes, Amarin will submit both R-IT and China specific study in their China NDA for V.
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