The Advisory Committee voted against recommending ANCHOR approval by a margin of nine to two. Joseph S. Zakrzewski, CEO said, ‘It's frustrating to have a number of panel members express that the company did everything that’s been asked of it for negotiating SPAs yet still not receive a positive vote for approval’.
The company conducted a successful MARINE study, a successful ANCHOR study, successfully enrolled the REDUCE-IT trial to over 6,000 patients and has a product that everyone ultimately agreed was safe. The company still continues to believe that a fair read of all the available data including available outcome studies reflect positively on Vascepa, the ANCHOR indication and the anticipated results of the upcoming REDUCE-IT study.
http://stks.co/pXC0
The company conducted a successful MARINE study, a successful ANCHOR study, successfully enrolled the REDUCE-IT trial to over 6,000 patients and has a product that everyone ultimately agreed was safe. The company still continues to believe that a fair read of all the available data including available outcome studies reflect positively on Vascepa, the ANCHOR indication and the anticipated results of the upcoming REDUCE-IT study.
http://stks.co/pXC0