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Re: Greymatter1 post# 18153

Saturday, 10/19/2013 10:39:50 AM

Saturday, October 19, 2013 10:39:50 AM

Post# of 426531
Well said!

We can ask for a new sNDA without that language or ask for a modified approval before the 20th...

Or we can get the rejection on the 20th then submit an appeal.

Not sure what processes are available yet Joe Z did say on the CC that Amarin would be spending a lot of time at the FDA between now and the 20th.
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