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Re: rafunrafun post# 37736

Sunday, 11/02/2014 7:44:08 PM

Sunday, November 02, 2014 7:44:08 PM

Post# of 430692
Technically everything is still possible:
- ANCHOR approval
- CRL with recommended action:
a.) modified indication and / or
b.) ANCHOR data on label or
c.) accelerated sNDA submission
- CRL w/o short-term solution (complete R-IT)

Meanwhile, no deadline for the sNDA I do not think that FDA will wait till R-IT result. I think (hope) they will act within the next 6 months.

Until FDA's action AMRN has to playing nice.
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