Replies to post #224084 on Amarin Corp Plc (AMRN)

[Whalatane]

Atom ..well I think you have that wrong .

Amarin will not ask for a primary prevention label ---except for that subgroup of primary prevention patients that are diabetic etc .and were included in R-IT .

R-IT did not include a vast number of non diabetic primary prevention patients ...so Amarin has no data to base a claim for that label .

In reality ...once approved ...many primary prevention patients on statins with family history and TG's still above 135 mg/dl ...will get scripts for all the reasons JL has explained

JMO
Kiwi

[Biobillionair]

Atom-

theres no R-IT data on non diabetic primary prevention patients to support a label inclusion

Has anyone ever heard of JELIS study? Amarin does have a collaboration agreement with MOCHIDA and JELIS was a primary indication population.

Per 10-Q: Page 43 top https://investor.amarincorp.com/node/18261/html

consideration of REDUCE-IT results in the context of other clinical studies

R-I confirms EPA:AA ratios “similar to” JELIS...per Dr. Briton here:

https://www.regulations.gov/document?D=FDA-2019-N-3936-0098

2. REDUCE-IT data are corroborated by JELIS data:
a. using an essentially identical agent (pure EPA ethyl ester)
b. in a similar population (high ASCVD risk)
c. with similar achieved plasma EPA levels
d. with a similar %RRR

Everyone should expect that AMARIN wants JELIS on R-I labeling and a primary care prevention indication.



BB

[rafunrafun]

A -

And let's not forget the 19% RRR in Hard MACE in that same primary prevention (diabetic w/ risk factor) population.

Any comment on the above quote by Avi?