Adam F. wirtes: "Moreover, I'd say odds that FDA approves an expansion of Vascepa label into the "Anchor" population of high triglyceride patients just went down. I could see FDA wanting to see positive data from the outcomes study as pre-approval requirement following the failure of the Merck Tredaptive study."
Am I stupid or what? Amarin conducted the Phase III Trials under a SPA and we all lnow what the endpoints were and how they were met. So please explain me why the approval of the ANCHOR indication should be a problem? The first endpoint is not "reduction of cardiovascular events"?
It's not. There is speculation that FDA should only approve new cholesterol lowering drugs if they prove to have a benefit in cardiac events.
1) This is a small percentage of people suggesting this
2)The FDA has not made any comment to lead to this
3) Vascepa has ZERO negative studies in regards to cardiac events so no reason to believe VASCEPA would have zero effect on cardiac events, only evidence out there suggests it DOES have a positive effect
4)Is a positive to Vascepa if FDA gets more stringent because vs. any possible competitor AMRN is the ONLY drug that has some evidence to reduce cardiac events
5) Jeffries said Niacin study positive for VASCEPA , they make sense
6)AF is a hack writer looking for web page hits, his opinion is wrong as much as it is right, he is no better than a coin flip, he is just trying to entertain. Bashing gets way more response than constant praise.
Pay no attention to his comments because they are senseless!! He has an agenda against Amarin and all he is interested in is driving the share price down at all costs. His comments in this article prove that out. Just a joke!!
The four year study with Niacin and a Statin was thought to show improvement in cardiovascular event because everyone thought the lowering of triglycerides was what would improve CV event but it did not.
In the same way that study may meet an endpoint that may not really do anything to improve CV event so it is a waste of money. So, they will have to wait until 2016 for a study to show Vascepa actually do anything to lesson CV events. It may lower triglycerides, but may not do anything about Cardiovascular events.