Replies to post #423129 on Amarin Corp Plc (AMRN)

[rosemountbomber]

And, if it was significantly different then I imagine a whole set of hoops to jump thru will be required by FDA

[Whalatane]

Ram et al. First any new version of Vascepa has to be bio equivalent to existing . FDA will want a short trial to make sure the new formulation has the same / similar side effects as original ...especially re Afib.
Second ...smaller, less pills for same clinical benefit is a huge marketing benefit ...especially if priced competitively with the existing .
Third. Pill burden is real . Many patients are required to take up to a dozen pills per day ...especially CKD patients that need to control serum phosphorus as well as their lipid profile.
All of this ( new formulation , competing against generics , pill size and number etc ) is playing out right now with UNCY and their drug OLC . Their final trial is underway ..results due late June 24 .
Suggest you look at that Ihub board for a road map if you think AMRN is likely to do down the " new formulation to compete against generics " road in the US .
JMO
Kiwi