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Biobillionair

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Biobillionair

Re: rafunrafun post# 195438

Thursday, 06/06/2019 11:28:16 AM

Thursday, June 06, 2019 11:28:16 AM

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RAF- To be honest I’m impressed the FDA has taken Amarin’s NCE issue to Congress this year in 2020 omnibus. The FDA still has Vascepa classified as Type 5 New Formulation or New Manufacturer...Not a type 1 New Chemical Entity...I have a theory FDA grants/changes Type 5 to Type 1 with approval of Vascepa R-I label.

Yes a makeup call on NCE perhaps restarting NCE clock in September 9-2019.

BB

Amarin is just as confused as me with Type 5 “submission classification”...

If you're not good at being yourself, then maybe that's being yourself!

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