Amarin Corp Plc (AMRN)

[jlucer53]

VASCEPA 2.0 and regulatory requirement for CVD LABEL

can someone with regulatory know how please advise. Vascepa 2.0 is a drug delivery system play (self emulsifying) 1x and without needing to eat a fatty meal correct?

Seeing how its the same molecule couldn't they get the CVD label as well without the outcomes trial? this isnt a new concept much like extended release to extended the franchise of a drug. Im sure this was going to be used nearing 2028/29 but it can be put into play within a year or two assuming the on going trial is almost done correct?

Can someone find an issue with this strategy? I dont see why it wouldnt work outside of waiting for the on going trial to complete but we should be able to apply for the CVD label right after correct? I cant find the trial online and i dont remember exactly when its completion date was set for.

Im not a regulatory expert but companies use drug delivery systems to extend branded life all the time ie extended release etc etc. Why cant we? Thoughts ?