Mumbai, India -- (SBWIRE) -- 10/18/2013 -- The Advisory Committee (AdCom) to the U.S. FDA mentioned that triglyceride-lowering drug Vascepa should not be approved for use in a broader patient population until results from an additional study have been analyzed. So, the AdCom meet results have been very disappointing for Amarin as it voted against the approval of the drug by a margin of 9 to 2. So, Amarin still needs to continue working hard to win the uphill battle for its proposed Vascepa ANCHOR indication.
The FDA is scheduled to make its decision on whether to approve the ANCHOR supplemental sNDA by December 20, 2013; that's the PDUFA date, company’s goal date for the application. Though FDA is not bound to follow the recommendations of its advisory committee, they typically consider it in their review.
CEO Joseph S. Zakrzewski mentioned at a conference call following the AdCom meet that they have enough cash to last well into the future, and that they need to have a complete look at the company from top to bottom to determine what the best course of action will be, and they are exploring all the possible options to make the cash last even longer. But industry analysts expect that the company will need to raise additional capital to fund the operations.
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