Amarin Corp Plc (AMRN)

[amarininvestor]

See below, this is extracted from the Amicus Curiae letter.

Wouldn't that mean that FDA must approve anchor. In other words, they need to expand label of vascepa as a drug that lowers triglycerides and that is safe for patients in the very high triglycerides (>500 mg/dL; or MARINE) to also include high triglycerides (200-500 mg/dl; ANCHOR). And it would be to the doctors to prescribe vascepa each time they feel they have to lower triglicerides, whether it is for pancreatitis (strong science behind it) or cardiovascular diseases (not completely proven but many doctors thinking that there are enough evidence to give such a safe drug to patients). Am I understanding this correctly?





"Although FDA determines the overall safety and efficacy of a drug as part of the drug approval
process, the Agency does not determine all the uses for which a drug may be safe and effective.
Thus, even if FDA had the authority, the Agency is in no position to overrule the medical
judgment of a healthcare professional regarding the benefits of a drug in treating his or her
patients. The prescribing physician is in the best position to understand the patient’s medical
history, condition, and potential responsiveness to a prescription drug."