Amarin Corp Plc (AMRN)

[Biobillionair]

Draft email to Janet Woodcock:

Janet-
It has recently come to my attention the generic drug industry, specifically Hikma Pharmaceutical USA Inc., may have been involved in communications with FDA that directly led to the FDA’s scheduling and communications of the 8-8-2019 Advisory Committee and sNDA delay for Vascepa. Are you aware of this?

The generic drug scheme SHOULD NOT delay a safe and effective cardiovascular medication.

If this has occurred I need you to immediately remedy the PDUFA delay; Vascepa needs a cardiovascular label that matches current standards of care to maximize cardiovascular event reductions in the US population.

Please respond back to me regarding this matter by October 14th, 2019. I am drafting a specific complaint to HHS OIG regarding this matter. This will be my only complaint to HHS OIG regarding Amarin/Vascepa/FDA.

Best Regards,

Jason

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Thanks

BB