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Re: None

Sunday, 10/06/2019 10:08:29 AM

Sunday, October 06, 2019 10:08:29 AM

Post# of 426469
Re: Hikma interest in R-I sNDA and timing of Ad Com

It is very disturbing to see Hikma interests in wording of Vascepa R-I labeling and the shortly after the production of sNDA table of content and redacted proposed labeling the FDA schedules a late cycle Ad Com.

Prior to Amarin taking the FDA to court for NCE, documents arose showing generic meddling in decisions to withhold NCE from Vascepa. This was included in the FDA “Exclusivity Committee” notes.

I feel Amarin stakeholders may have a developing case against Hikma regarding original PDUFA date of 9-28-2019. The proof is likely contained in Hikma FDA communications regarding the generic production of Vascepa, I am considering a FOIA request but also feel like stakeholders should do this through representation.

Any interest?

Our best bet on a law firm is King & Spalding...North recommended them to me years ago.

Interested parties can respond to me.

Thanks
BB

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