Apparently aware that these issues will be discussed at the oral hearings, the FDA gets them out there right away. These include the rescission of the SPA, the safety profile of Vascepa and the commitment of Amarin to complete REDUCE-IT. There is no mention of the NCE There are no detailed or convincing explanations (at least IMO) of their actions on any of these matters except to say that their mission is to prevent misleading and untruthful information from being disseminated . Most of the rest is just boilerplate.
News 
Market Data 
Discover 
AI
