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Re: None

Tuesday, 02/12/2019 9:33:51 AM

Tuesday, February 12, 2019 9:33:51 AM

Post# of 429025
Just sent to JT:

Hi John-

Just in case you haven’t seen the warning letters the FDA has recently sent, here’s a link: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630564.htm

Specifically relevant to Amarin and Vascepa quote:

On the webpage titled, “Omega 3 Benefits Stroke – Fish Oil Supplement May Help”:
Fish oil supplements have been shown to have anti-inflammatory effects in diseases such as cancer, asthma, rheumatoid arthritis, osteoporosis, dry eye disease, age-related macular degeneration, coronary heart disease and sepsis.”
“The use of fish oil supplements as a protective factor against stroke and other neurological diseases such as Alzheimer’s has been suggested.”


Hopefully we see the Federal Circuit Court FINALLY publish their ITC opinion, but the above should be reassuring from a legal stance the sNDA for REDUCE-IT won’t be used and abused by the supplement industry.

I look forward to watching you bring this home, and great job with the recent execution of raising cash and hiring sales. If the FDA doesn’t grant an accelerated approval I will obviously lose my shit, but there’s no blaming Amarin, you’ve put up a great fight.

Keep up the good work and please send a thank you to your leadership team.

Best Regards,

Jason



I have no information regarding when an sNDA will be filed, but it's one symbolic message if Amarin deliveries it Thursday 2-14-2019.

BB

I do not pump Amarin stock. I am not an Amarin cheerleader. If I see something I don't like I make it known. Patients come first, always!!!

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