Amarin Corp Plc (AMRN)

[slowmover]

"People on other boards are asking why we as investors were all told that was what Anchor app indication was for yet somewhere it changed to that plus treating people on Stains who have a higher risk in CVE's."

john indication is actually correct as stated in fda and amarin briefing document.



fda bd 3.2.1. Objectives
Primary objective: ANCHOR’s primary objective was to determine the efficacy of AMR101 2g
daily and 4g daily, compared to placebo, in lowering fasting TG levels in patients at high risk for
cardiovascular disease and with fasting TG levels = 200 mg/dL and <500 mg/dL, despite
treatment to LDL-C to =40 mg/dL and =115 mg/dL on statin therapy

amarin bd page 51
On 6 July 2009, Amarin reached agreement with the FDA on a Special Protocol Assessment for the ANCHOR protocol (add-on to statin therapy), including the following additional key design elements:
• The primary endpoint would be the placebo-adjusted percent change in TG from baseline to Week 12.
• The study would enroll patients at high risk for CV disease
• LDL-C at randomization must be between > 40 to <100 mg/dL
• Statin dose must be stable for at least 4 weeks before randomization and must remain constant throughout the 12 week study
• Key secondary endpoints were identified to control for Type 1 error.
The IND was amended to begin the SPA-agreed ANCHOR study.
Although the NDA contained all of the data for ANCHOR, as previously indicated, the FDA did not review the efficacy data at that time.



the problem is not in the proposed indication.
imo the problem is fda themselves is predicting that vascepa
won't show benefit in reducing cvd and cvd risk using few studies
which don't work the same as vascepa although they ie. accord aim-high also reduce triglycerides.