Replies to post #16354 on Amarin Corp Plc (AMRN)

[KCSVEN]

REDUCE IT is mentioned but considering having reduce it underway was part of the agreement and the main focus is efficacy and nothing related to safety it is pretty straight forward. FDA has said underway is enough, panel should agree with no safety issues mentioned it will be OK to approve.

Expect near unanimous approval on this

Agenda is up also

[exwannabe]

Let the debate begin:

Several cardiovascular outcome trials of non-statin lipid-modulating therapy, such as those referenced by the Division in 2008, have since completed. ACCORD-Lipid, AIM-HIGH, and HPS2-THRIVE, which were designed to target residual cardiovascular risk by improving lipid parameters other than LDL-C (e.g., HDL-C and/or TG) in patients optimally treated with statin therapy, failed to demonstrate unequivocally additional cardiovascular benefit from non-statin lipid-modulating drugs. Severalhypotheses could be put forward regarding the failures of these large, carefully designed trials todemonstrate benefit on their primary endpoints, but the evidence to date certainly challenges the hypothesis that adding lipid-modulating therapies to patients optimally treated with statins will reduce residual cardiovascular risk. Although it can be argued that lipid and/or lipoprotein parameters can be used to define subpopulations of statin-treated patients who would be expected to benefit from various non-statin lipid-modulating agents, contemporary trials have not yet prospectively tested this hypothesis. Members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)are asked to consider the results of the ANCHOR trial in the context of the available science when recommending whether to approve the proposed treatment indication for 4 grams AMR101 daily to be co-administered with statin therapy for the treatment of patients with mixed dyslipidemia and coronary heart disease (CHD) or its risk equivalent.

[ziploc_1]

Answers to both questions...one word JELLIS

[sts66]

discuss your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population.

I do NOT like that question, and apparently neither does the market - reason for the crash IMO. They're essentially asking the panel to guess how REDUCE-IT will turn out using results from ANCHOR trial, which was NOT powered to measure reduced CV risk!