Amarin Corp Plc (AMRN)

[IgnoranceIsBliss]

Hamoa, Jelis was not a flawed trial, it was designed for what it was designed for.

AMRN has consistently touted JELIS as a strong indicator that Vascepa would show CV benefit after long-term use.

But JELIS was a trial for high-cholesterol Japanese patients. Average trigs in the trial was around 150. All were on statins. Trig and other biomarker reductions were not endpoints of the study -- it was all on CV events. Trig levels in the trial fell 9% on the EPA arm and 4% on the control arm. This is a fact AMRN has often cited when explaining that trig reduction doesn't explain what Vascepa is doing.

JELIS showed CV reduction, and was not helpful to someone who was trying to show that EPA would reduce trigs substantially while not raising LDL-C or ApoB. (To the best of my knowledge they didn't measure ApoB in this trial, and LDL-C went down on both arms, I believe.)

This is why JELIS isn't cited as one of the key prior art elements for the defendants.

The reason the defendants wanted all the back and forth with the FDA is that they were fishing for arguments BECAUSE THE ONES THEY HAD SUCKED.

AMRN's reluctance stemmed from the fact that "obvious" doesn't mean "obvious to the inventor". It means obvious to an ordinary skilled person in the area. Nothing of this sort was obvious to such a person. The defendants know it. And when the judge tells them to GFT on the motion to exclude REDUCE-IT, then they KNOW they are f'ed for good.