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Re: stangish post# 7065

Friday, 05/24/2013 3:58:48 PM

Friday, May 24, 2013 3:58:48 PM

Post# of 426474
Amarin was ask for an expensive outcomes study, It's called REDUCE-IT. It was designed under SPA also. The FDA may get a chance to review the current status of REDUCE-IT and probably the reason they wanted REDUCE-IT 50% enrolled before Anchor sNDA. Early data should point to success when reviewing the JELIS timing.
In fact, the FDA may have reviewed REDUCE-IT data prior to the acceptance of the sNDA for Anchor.
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