Replies to post #115673 on Amarin Corp Plc (AMRN)

[iwfal]

I agree the bleeds data is disputable. Again, my point isn't that I know bleeds will be an issue in the Vascepa ph3. My point is that it is dangerous to dismiss it as a risk - it shows up in both Jelis and in the randomized trials that Vascepa submitted for approval. Per FDA's Vascepa Medical Review:

In the Hypertriglyceridemia, Placebo-Controlled dataset, there were 3.4% bleedingrelated TEAEs in patients on Vascepa compared to 1.9% of patients on Placebo. The percentage of bleeding-related TEAEs was similar for patients on Vascepa (2.5%) as compared to Placebo (2.5%) in the CNS Placebo-Controlled Integrated Dataset.

BTW - another potential risk is HbA1c. That said, the biggest risk is the potential for meaningful trend against Vascepa in overall death.