Amarin Corp Plc (AMRN)

[Whalatane]

RMB. doubt if any BP is interested until this raging debate ( Medscape article copied and pasted )....is settled . And we will need RESPECT EPA at least for that

Bhatt: New Data Do Not Change the Debate

"We did a large, well-powered randomized trial, and this paper shouldn't change anything in how that trial should be interpreted," Bhatt told theheart.org | Medscape Cardiology.
He claims the new biomarkers evaluated in the study are correlated with LDL and CRP, data which have already been reported and analyzed, so have limited relevance.
"It's not really independent biomarker information; this is what we would expect to see when we see small increases in LDL and CRP. So, I don't think this new information fundamentally changes the debate," he said.
Bhatt also pointed out that the study highlights relative increases rather than absolute increases in the biomarkers, making it seem more alarming than is actually the case.
"The paper makes it seem like that there are large increases in these other biomarkers, but the values reported are relative increases and the absolute increases were actually rather small. In many cases, the changes reported are less than the lower limit of quantification of the assay used," he noted.
He added: "Even if one is unable to get around the placebo issue in the REDUCE-IT trial, there will always be the JELIS trial — a randomized trial with no placebo showing a 19% relative risk reduction. While the biomarker data may be interesting, what really matters in the end is clinical events. And significant reductions in two independent trials should be enough."
Bhatt says the REDUCE-IT steering committee does not believe another trial is needed. "Maybe a different population would be good — such as primary prevention, patients without elevated triglycerides — but just repeating REDUCE- IT with a different placebo would be a waste of resources," he commented.

But Nissen refuted Bhatt's claims.
"These biomarkers are not in the same pathways as LDL and CRP, and these are not small increases. In the CANTOS trial, a monoclonal antibody against interleukin-1ß beta showed a significant benefit. The increase in interleukin-1ß now reported in REDUCE-IT is exactly the opposite of CANTOS," he pointed out.
"The FDA did not know about these additional biomarkers when it reviewed the data on LDL and CRP. Now we have new information. It needs to be looked at again," Nissen added.

Kiwi