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Re: Mr1979 post# 352533

Saturday, 08/28/2021 12:34:29 PM

Saturday, August 28, 2021 12:34:29 PM

Post# of 426586
Mr1979. I would be very surprised if the FDA granted EUA status based on a trial that did not include some US patients … no matter how good the results were .

If PREPARE -IT succeeds hopefully we would have the Kaiser US patient MITIGATE trial to confirm ASAP .

It’s a huge plus that Vascepa is already FDA approved with extensive safety data so if P-IT succeeds Amarin should be able to widely publish the results and MD’s could prescribe off label

I expect them to “ mine “ the data for subgroups who may benefit the most … eg older patients with comorbidity’s

Kiwi
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