Jasbg, this obviously would be a huge step for Amarin. However, since they have essentially had those patients removed from observation for 4+ years, would it stand to reason that this study would (could) only be used for internal purposes?
In other words, it could not be of any value to the FDA, since there was a 4 year lapse in control. Not to say the study itself would not be of value - it could certainly help Amarin make decisions on potential formal studies to run. But would the FDA realistically rely on analysis of a cohort that was out of their hands for 4 years?
And I don't know the answer. I am really just curious. I have often wondered if they could have gone back to the REDUCE-It patients that are still on Vascepa to do further analysis of their medical records since the trial ended.
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