Replies to post #391674 on Amarin Corp Plc (AMRN)

[Number sleven]

Zip, To me the question of why gv doesn't increase serum EPA levels is somewhat irrelevant. If gv isn't producing identical biological effects, I don't understand how it can be considered an A/B generic version. Especially since the Method for CVD prevention is unknown.
Sleven,

[north40000]

ziploc, Hikma et al have been proceeding, IMO, under the bare assumption that the bio equivalence data furnished to the FDA proves the EPA molecule Vascepa in the respective capsules of Amarin and other generics was, and is/remains, identical with respect to another, not investigated variable—residence TIME in the capsule. Did FDA ever have stability data of the generic molecule(s) from its own studies, or furnished to it by generics or Amarin, with respect to months or years of time? Dr. Taub et al in San Diego may have their own clinical data from their treated patients that shows V produces EPA serum levels higher than gV.

Vascepa capsules have a shelf life of 4.5 years. I have not been able to determine whether shelf life of the generics’ molecules is the same or is actually different— 2 or 2.5 years is a value I have seen from others here.