Replies to post #263078 on Amarin Corp Plc (AMRN)

[Whalatane]

Rose ...the FDA is not relevant here IMHO ....except as related to generics ANDA filing and approval
They have approved the Marine and R-IT indication ...thats it .

It doesn't matter wether Vascepa is brand or generic to them does it ? Thats not their mandate

Regarding Cowen ...when decision first came out they valued either Co plus CVR or EU at $10 ...now down to $8 .
I'm surprised they are valuing AMRN that low frankly .

Kiwi

[moonotaur]

How does the FDA know that a generic would have the same benefits as the real thing?

Given the extensive refinement process that Vascepa goes through and given an MOA is not yet clearly known, how can the FDA determine the generics will be the same? I would petition the FDA require an outcomes study before approval...