Amarin Corp Plc (AMRN)

[AVII77]

There are tons of additional gems buried in the results that will be revealed over time as they continue the analysis.

Yep.

In fact, I see they added some last minute exploratory endpoints as late as August.





I also noticed they had a pre-sNDA meeting last March.

The purpose of this Statistical Analysis Plan (SAP) Addendum is to describe and document additional pre-specified statistical analyses and specifications beyond those that were prespecified in the approved SAP version dated 08 July 2016, which will be included in the final analysis and reporting of clinical data collected during the conduct of Protocol AMR-01-01-0019. As discussed and agreed with the Food and Drug Administration (FDA) in relation to a pre-sNDA meeting on 07 March 2018, this SAP Addendum has been developed and will be finalized and submitted to the AMR101 investigational new drug application prior to database lock and unblinding. Importantly, the additional efficacy endpoints and analyses outlined below in this SAP Addendum are exploratory in nature and will not be included in the formal SAP testing scheme. Results from the exploratory analyses described herein will be included in the AMR-01-01-0019 clinical study report (CSR).

I need to find someone who can take paint off a boat .......



finally, I thought you might be interested in the decision tree for interim stopping. Couldn't rotate it correctly. But seeing as this was a topic of much discussion over the last few years I thought I would share it here.