Amarin Corp Plc (AMRN)

[HDGabor]

Kiwi,

The type of the SPA doesn't matter.

Did ANCHOR study establish a drug’s effectiveness by "substantial evidence"?
Did it demonstrate that pharmacological reduction of TG with V, in patients with elevated TG levels at LDL goal on statin therapy, significantly reduces residual cardiovascular risk?

The answer is: no. Substantial scientific issue not available to determining the efficacy of V.

Meanwhile FDA has been flexible within the limits imposed by the congressional scheme, broadly interpreting the statutory requirements to the extent possible (With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes), it does not mean they HAVE TO BE flexible. Furthermore they don’t require more than the law: The effectiveness requirement for drug approval was added to the Federal Food, Drug, and Cosmetic Act (the Act or the FDC Act) in 1962, which included a provision requiring manufacturers of drug products to establish a drug’s effectiveness by "substantial evidence".

To avoid any doubt: Effectiveness means reduces residual cardiovascular risk (not pharmacological reduction of TG).

FDA did not rule out that Vascepa isn't effective, they are requesting "substantial evidence", proof of cardiovascular risk reduction effect.