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Fly News Breaks for August 13, 2019
NVO, AMRN
Aug 13, 2019 | 10:20 EDT
Roth Capital analyst Yasmeen Rahimi noted that the FDA's upcoming Advisory Committee reviewing the sNDA for Amarin's (AMRN) Vascepa will include ten voting and one non-voting committee members, including five endocrinologists, three cardiologists, a biostatistician, a pharmacoepidemiologist, a consumer representative and a non-voting nephrologist. Given that the American Diabetes Association has included Vascepa for CV risk reduction in its recommended treatment guidelines, and the panel has a majority of endocrinologists, she believes that "the committee is primed for a positive reception of Vascepa," Rahimi tells investors. Additionally, the AdCom Chairperson, Dr. Kenneth Burman, previously voted in favor of Novo Nordisk's (NVO) insulin degludec and insulin degludec/aspart when chairing a prior AdCom. Rahimi reads this as a strong sign that he is receptive to new therapies and as a positive for Vascepa's review, she said. The analyst keeps a Buy rating on Amarin shares with a price target of $31.