THE GUARANTEED REASON WE GET NCE...AFTER ALOT OF RESEARCH
Drugmaker's comments make more sense to me. Vascepa is an exception that FDA is making. I do agree that it's in line with the strategic goal of NCE even though it may or may not meet the verbatim definition of NCE. But NCE definition is just a mean to the end. It's the end that is more important - encourage/protect innovation and clinical data.