Amarin Corp Plc (AMRN)

[Benny7459]

IR's thoughts on futility:


"In our view, futility analyses are often inserted by companies that have less confidence in a clinical trial result and/or when there are significant safety concerns with the therapy being studied. Futility analysis can lead to pre-mature study stoppage in studies were events increase over time and where the completion of the study could be successful if the study is allowed to complete as the added time provides time for curves to separate. Given what we know about the safety profile of Vascepa and give our desire to capture a robust trial results, neither we nor FDA recommended adding a formal futility analysis to the interim looks in REDUCE-IT."


Thanks!
Benny