The law firm of Wohl & Fruchter LLP is investigating possible violations of federal securities laws by officers and directors of Amarin Corporation plc (Amarin) (NASDAQ: AMRN).
On October 11, 2013, the Food & Drug Administration (FDA) released its briefing documents for the scheduled October 16, 2013 advisory committee review of Amarin’s application seeking expanded approval for the use of its fish oil-based drug, Vascepa, in the treatment of adult patients with high triglycerides with mixed dyslipidemia.
The FDA briefing documents raised questions about the mineral oil placebo used in the ANCHOR clinical trial intended to support the expanded approval, thereby potentially negatively impacting the control group data, and suggesting that “the treatment effects observed with [Vascepa] may be overestimated.”
The FDA briefing documents also suggested it may be prudent to await the results of the REDUCE-IT trial being conducted by Amarin to evaluate the effectiveness of Vascepa in reducing cardiovascular events (which will only be completed in approximately six years) before approving expansion of the treatment indication for Vascepa.
On the above news, AMRN shares declined over 20%.
Wohl & Fruchter’s investigation concerns whether Amarin management misled investors concerning, among other things, potential flaws in the design of the ANCHOR clinical trial, and the potential relevance of data from the ongoing REDUCE-IT trial to approval of the expanded indication for Vascepa.
Persons with relevant information, and AMRN shareholders with questions about this investigation, are invited to contact the attorney below, or our Firm by calling 866.833.6245.
Additional information, including a copy of the FDA briefing documents referenced above, is available on our website at:
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