Amarin Corp (NASDAQ: AMRN) released first quarter 2012 financial results and held a conference call on May 8, 2012. It is often hard to distinguish the signal from the noise when it comes to chatter about AMRN on Twitter and other venues, so we will try to objectively update where things stand as the July […]
AMRN – Will AMR101 receive New Chemical Entity (NCE) Status from the FDA?
Why does this question of New Chemical Entity (NCE) status matter? Simply put, if AMR101 is designated as a New Chemical Entity (NCE) by the FDA, the product receives five years of market exclusivity after approval in the United States, regardless of the patent situation (sometimes referred to as Hatch-Waxman exclusivity). During this time the FDA will […]
