Amarin Corp Plc (AMRN)

[TCI1]

The Brave trial was designed and commenced before the new FDA guidelines on approving preclinical AD drugs were published. Regardless of what the purpose of the trial is, if the new guidelines allow for approval based off specific biomarkers then Amarin are eligible to submit, and subject to statistical significance, safety & other relevant requirements, be reviewed for approval. This is the reverse of what happened with Anchor when the FDA changed their guidelines after signing an SPA with Amarin that biomarkers would no longer be acceptable to approve reduction in MACE events.

Also - p values are a scientific benchmark for assurance on the probability as to the accuracy of the results. Whether N is 131 or 2,000, what matters is the p value when using biomarkers as the outcome. So IF the p value is statistically significant in Brave, doing another larger trial would be largely pointless, otherwise why have p values if you don’t rely on them.