Replies to post #34952 on Amarin Corp Plc (AMRN)

[zumantu]

JL , you raise an important point.

I think the rescinded SPA has to be challenged to help ensure the Reduce It SAP is adhered to

[HDGabor]

JL,

The definition of "significant" in terms of either safety or efficacy, required to violate the contract

The SPA is very specific. This must be new scientific evidence. There is no new scientific evidence regarding Vascepa or its API.

It is the main difference between us (and it is a big error in the SPA). The SPA does not contain anything about what is necessary for the determination. It’s about the determination itself.

"A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun."

"The FDA has revaluated the situation and has adopted a more conservative approach than previous applied for biomarker based approvals targeted towards cardiovascular risk reduction." (from CC transcript)

Agree w u, the determination is wrong, but they have a legal background to determine.

R-IT results come in positive and the FDA still does not allow the labeling change. How you ask could they do that..Well look back at the AdComm. The FDA could manufacture more excuses...bleeding problems, the placebo. How can you trust them?

As the “the magnitude of the changes in several lipid and lipoprotein parameters, as well as biomarkers of inflammation, between baseline and Week 12 in the placebo group are rather atypical for lipid-lowering trials.” it was not special. ANCHOR was about lipid-changes and short-term (12 weeks), meanwhile R-IT about hard outcome and long-term study. To ignore the R-IT result the placebo group has to show abnormal, high event rate (btw: in this case the study will be stopped earlier due to safety reason) changes in several lipid and lipoprotein parameters (if any as it is long-term) will not be enough.