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Re: johnking29 post# 24808

Saturday, 01/25/2014 12:04:54 PM

Saturday, January 25, 2014 12:04:54 PM

Post# of 426268
You would have thought that AMRN, with all their experienced people and their lawyers and those familiar with the FDA process would have known better.

[i]"I asked why the Anchor application mentioned CVE's when Anchor was ONLY an extension of Marine (which has an exception to CVE's and is one of the reasons why the FDA approved them the 1st time!)

He said you normally list the ultimate intent in your application when you file a sNDA.

Had Amarin ONLY asked for an extension of Vascepa for the 199 to 500 class with the application noting that the Anchor label will carry the very same exceptions as Marine, we probably would not be talking about this now..."

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