Amarin Corp Plc (AMRN)

[DeepBreath]

Email From CDER

Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER), regarding PCSK9 drugs.

We greatly appreciate you taking the time to share your opinions with us. Your comments and concerns regarding PCSK9 drugs have been forwarded to the appropriate group within the Agency for further consideration.

Best regards,

KDe
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

MY REPLY:
To whom it may concern,


My comments and concern do not only apply to the PCSK9 drugs and I am offended that it has been dismissed as such. Please reread the email and understand that this involves how the FDA is interpreting "new science" that is affecting the decision and recission of the SPA for Amarin's Anchor Indication. The studies involved (Accord-Lipid, Aim-High and HPS2-Thrive) should not allow the FDA to extrapolate outcomes without an apples to apples comparison. I look forward to an honest and open discussion with the FDA regarding this issue.