thank you sir for your many insightful posts, and with no disrespect, why would the ceo joe Bruno, retract the companies mission, in their efforts toward reducing cve's, when their studies have proved that amr1010 and ALLLLLLLLL are so many studies supporting their endpoints.
Johnking johnking, you never cease to amaze me. You know as well as anyone that the FDA approved Vascepa for TG >500 because TG's at that level is KNOWN i.e. proven to cause acute pancreatitis (HTGP), period! The problem is that TG's in the 200-499 range is not known for a fact that it is tied with CVD or anything else for that matter.
You would have thought that AMRN, with all their experienced people and their lawyers and those familiar with the FDA process would have known better.
[i]"I asked why the Anchor application mentioned CVE's when Anchor was ONLY an extension of Marine (which has an exception to CVE's and is one of the reasons why the FDA approved them the 1st time!)
He said you normally list the ultimate intent in your application when you file a sNDA.
Had Amarin ONLY asked for an extension of Vascepa for the 199 to 500 class with the application noting that the Anchor label will carry the very same exceptions as Marine, we probably would not be talking about this now..."
Appreciate the info now I understand a lot more about why Amrn can not just go for 200-499 TG class. Again thanks, you did an excellent job explaining things!
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