Replies to post #441142 on Amarin Corp Plc (AMRN)

[Tatsumaki]

It doenst "suggest" anything. It plainly states if a drug or indication is developed and approved overseas, China deducts the time from that overseas approval from the exclusivity window in China. If you want exclusivity in China, develop the drug in China for 6 years, or run studies in China for a new indication for 3 (like Mochida is doing with Sumitomo... running trials in China...).

but suppose a competitor could develop a generic using data from US generics rather than Amarin directly.

Generics dont generate data on their drugs/indications. They copy existing approved formulations/indications and use the trials the developer ran to first approve the drug.

[Tatsumaki]

Edding committed to deal before newer Chinese regulatory environment eroded value? Still not sure there is a CVRR competitor and hence still seeking NRDL.

The Chinese version of the Orange Book and the recent 6/3 updates are new. Prior to that, if memory serves, the protection of overseas drugs in China were basically non existent. I posted them a few years ago... something like 18 months max. So saying these changes "eroded value", well, there was no or minimal exclusivity in Vascepa's case to begin with. For new drugs that aren't 40 years old before going to China, it's a regulatory improvement if China actually defends the exclusivity and uses their patent linking.

Nevermind the fact that Edding fumbled around for years in the agreement before actually doing anything...