Amarin Corp Plc (AMRN)

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From JP Morgan transcript at https://seekingalpha.com/article/4662245-amarin-corporation-plc-amrn-42nd-annual-jpmorgan-healthcare-conference-transcript

“Lastly, we are very encouraged by our rest of world progress, particularly China, where we've launched the very high triglyceride indication and we have had -- the China FDA accepted our filing for cardiovascular risk reduction.”

I understood this to mean the filing was received, perhaps met compliance checks: “we got your filing”… and not yet evaluated let alone approved.

Later Holt said:
“When we think about rest of world, there are millions of patients that we have the opportunity to access with our important partners globally. As one example, in China, we have just now launched the very high triglyceride indication in China and we have had the, as I mentioned, the larger cardiovascular risk reduction indication accepted by the China FDA with a clinical trial waiver, which is a very important milestone for the business via our partners, Eddingpharm.”

I don’t think he was choosing words carefully to mislead but unfortunate if read as stated that the “CRR indication” was accepted as it’s clearly just the filing from everything else that has been publicly disclosed. I would like to hear more about the details/meaning & confirmation of “clinical trial waiver”... how is it waived before filing is processed and approved? I know very little about the Chinese drug approval process.

Here is the Eddingpharm press release:

NMPA Accepts Marketing Application for VASCEPA® (icosapent ethyl) Cardiovascular Risk Reduction (CVRR) Indication
https://www.eddingpharm.com/EN/newsDetail/1141
SHANGHAI, CHINA, November 14, 2023 - EDDING announced that the new indication marketing application for the innovative cardiovascular drug VASCEPA® (icosapent ethyl) has been officially accepted by the National Medical Products Administration (NMPA).This indication would allow for VASCEPA® to be used in combination with statins for adult patients with elevated and high triglycerides (TG)and established cardiovascular disease or diabetes mellitus with =2 other cardiovascular disease risk factors, combined with hypertriglyceridemia, to prevent and reduce the risk of cardiovascular events (including cardiovascular death, myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization).
“"We are very pleased that the application for the CVRR Indication of VASCEPA® was accepted by the NMPA”, said Jing Zhai, Vice President of Business Department, EDDING.”
“For the currently submitted indication, VASCEPA® can provide a new and strong evidence-based treatment option to reduce residual cardiovascular risk in statin treated patients with elevated and high TG levels in clinical practice. We will hope that in the future, VASCEPA® could help to reduce ASCVD risk and events in patients, contributing to the comprehensive management and prevention of cardiovascular diseases in China."
“On behalf of the Amarin we team, we congratulate our partners at EDDING for this critical step in their efforts to secure the CVRR indication for VASCEPA® as a potential expanded indication for patients in China," said Steven Ketchum, Ph.D., President, Research & Development and Chief Scientific Officer, Amarin.
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