In a Jan. 21 story about the expanded use of Amarin's drug Vascepa, The Associated Press reported erroneously that the company believed a committee of FDA advisers would have found in its favor if a special protocol had been in place. The company believes that the advisers would have found in its favor if they had been asked to consider a special protocol assessment that was in place at the time. A corrected version of the story is below: Ahead of the Bell: Amarin shares take another fall Amarin's stock plunges after drugmaker announces another Vascepa approval-related setback Shares of Amarin tumbled nearly 30 percent before markets opened Tuesday after another setback in its quest to gain approval for the wider use a fish-oil based pill, its only product. Federal regulators have refused to alter their stance on the design of research related to that broader use, the company said. Shares of the Irish specialty drugmaker started getting pummeled last fall after a panel of Food and Drug Administration advisers voted against recommending a broader use of the pill, Vascepa, which is designed to lower triglycerides, a type of fat in the bloodstream. Vascepa was approved in 2012 for patients with unusually high triglyceride levels. Amarin also wants to market the drug for patients with high triglyceride levels and heart disease who are already taking a statin drug to help control their cholesterol. In October, a majority of panelists said that while Vascepa significantly lowers fat levels, it is unclear whether that actually translates into fewer heart attacks. The panel said the FDA should delay a decision on expanded use until Amarin completes a study of patient heart attack rates. Amarin has said that it believes those advisers would have recommended the broader use if they had been asked to consider a special protocol assessment that was in place at the time. That's an agreement between the company and the agency over the design of research. Regulators rescinded the agreement a couple weeks after the committee's decision, and the drugmaker had asked the Food and Drug Administration to reinstate the agreement. On Tuesday, Amarin said a division within the FDA does not plan to reinstate the agreement. The drugmaker plans to appeal that decision and said it does not expect the FDA to decide on the expanded use while the appeal is pending. Shares of Amarin Corp. slid 67 cents to $1.60 , just over an hour before markets opened.
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