Amarin Corp Plc (AMRN)

[HDGabor]

K-

You react to the topic that wasn't in my post ...

But, the Co, guidance was both:

Given the high thresholds of overwhelming efficacy and safety typically required to be achieved prior to an independent DMC recommending an early stop to a large long-term cardiovascular outcomes trial like REDUCE-IT, management continues to believe that it is most likely that the REDUCE-IT study will run to its completion.

If not stopped early and the study is continued to completion, which is the base-case scenario, we expect study completion in 2017 with presentation and publication of results in 2018.

the interim result's projected to be reviewed by the independent Data Monitoring Committee in 2016 lead to stopping the study early based upon overwhelming efficacy, which is possible, even if not the most likely, scenario.

if the results are comparable to JELIS the committee could elect to stop the study earlier due to overwhelming efficacy, potentially leading to an opportunity to seek approval for expanded indication for Vascepa earlier than expected, if REDUCE-IT is as successful as we believe that it's positioned to be, the opportunity is much larger than typical Phase III results. ... So we are again blinded to the results of the REDUCE-IT study but it's certainly possible that we could get surprised with a very nice Delta here when that interim look does occur

If the REDUCE-IT study is not stopped early in 2016, this should not be a surprise to anyone and should in no way be interpreted to suggest that this study is not positioned for success.

They guided not to expect (based on previous, large long-term cardiovascular outcomes trial, which were done by different type of drug) but did not rule out the possibility (based on JELIS trial, that was "similar").

When any sponsor of double-blinded study said / guaranteed an early stop with 100% certainty before interim analysis?

Best,
G