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Re: None

Saturday, 01/11/2014 11:57:20 AM

Saturday, January 11, 2014 11:57:20 AM

Post# of 430686
THERE IS ONE OTHER POSSIBILITY. There could be an in-between alternative between re-instating the ANCHOR SPA as is and re-instating the ANCHOR SPA w/change requiring ANCHOR submittal with full REDUCE-IT results...and that is, the FDA may ask Amarin to supply POSITIVE interim analysis results from REDUCE-IT along with the ANCHOR submittal and then the FDA may be willing to approve the ANCHOR indication. This is much better than having to wait until 2016 AND it sort of helps the FDA walk a fine line between what the Adcom did and not totally ditching the ANCHOR NDA.

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