Amarin Corp Plc (AMRN)

[HDGabor]

z-

at the least the FDA should write an an Amicus brief

FDA does not have any task / work with patents other than record in the OB (if submitted / requested by the patent owner) and consider during ANDA approval.

the FDA, itself, was unbelieving that the Marine study could show that EPA could lower trigs in patients with over 500mgms/dcl WITHOUT increasing LDL(and thereby lower the incidence of cardiovascular events)

??? FDA did not question the MARINE result … EPA could lower trigs in patients with over 500mgms/dcl WITHOUT increasing LDL. Incidence of cardiovascular events (among patients with over 500mgms/dcl) was not a factor, it was about TG reduction only … the primary (and one and only) reason of a treatment.

At the Anchor Adcom the FDA all but directed the panelists to say they did not believe this either.

ANCHOR (and R-IT) was (were) about the incidence of cardiovascular events (among patients with TG between 150/200-499mgms/dcl) and the FDA - correctly - did not believe that lipid modification is enough - as a scientific proof - for decrease of CV events.

LDL-C change and CV events "does not" matter for TG > 500 … everything - if TG reduction was observed - were approved, despite negative effects (e.g. LDL-C increase in case of Lovaza).

Best,
G