Amarin Corp Plc (AMRN)

[Pyrrhonian]

Good point, but we still don’t know the details. If there was some issue still with the placebo possibly being non-inert, they couldn’t at that point change it, or else that would negatively impact data. It was fully enrolled even.

FDA remains blinded to data, including lipids, so as not to bias decisions they may need to make before the study is over.

We just don’t know what stipulations exist in the SPA unless we can see it. The fact that AMRN listed it in their risk section tells me it’s still an issue:

The FDA... directed the DMC for REDUCE-IT to periodically review unblinded lipid data to monitor for signals that the placebo might not be inert. After each such quarterly unblinded safety analysis and review meeting to date, the DMC has recommended to continue the REDUCE-IT study as planned. Each of these ongoing DMC recommendations has been shared with FDA. Amarin and FDA remain blinded to such study data. Despite the currently positive disposition of this matter, it illustrates that concerns such as this may arise in the future that could affect our...regulatory review...