According to Canaccord Genuity life sciences analyst Ritu Baral, AMRN FDA approval of cholesterol drug AMR101 is likely today. She told investors: “We expect three-year exclusivity will be granted to AMR101 under Hatch- Waxman’s ‘new clinical investigation’ clause. We think there is a good chance FDA may rule AMR101 is a new chemical entity, giving five-year exclusivity.” She added, “While the Hatch-Waxman statute (see main provisions of the bill) appears to present a black-and-white case against NCE status for AMR101, we note that FDA interpretation of the statute in the context of real- world clinical development, especially the development of naturally derived products that were approved with relatively poor characterization, leaves significant room for an alternate outcome.”
