Amarin Corp Plc (AMRN)

[CaptBeer]

My letter to Dr. Steve Ketchum:
5/12/2023
[e-mail]
For the attention of Dr. Steve Ketchum; CSO

Hello Dr. Ketchum,

As you know, Inflammation is currently in the spotlight for a host of human conditions from cardiovascular to neurological. The role and importance of EPA in regard to the former is becoming increasingly relevant, and in regard to the latter, may be a game changer for the VASCEPA® molecule. I recently came across a pre-print article entitled:

“Efficacy and acceptability of anti-inflammatory eicosapentaenoic acid for cognitive function in Alzheimer’s dementia”
https://doi.org/10.1016/j.bbi.2023.04.017

The objective of this frequentist-model based network meta-analysis (NMA) was to evaluate the potential advantages of omega-3 PUFAs and currently FDA-approved medications for AD on overall cognitive function in AD individuals. The primary outcomes were: (1) changes in cognitive function, and (2) acceptability, which refers to all-cause discontinuation. Additionally, secondary outcomes included quality of life, behavioral disturbances and safety/tolerability, which was assessed through the frequency of any reported adverse event.


Please take a look at the results of this study which suggests that the efficacy of high dose, high EPA/DHA ratio treatments are orders of magnitude above current AD treatments and current OMG-3FA formulations. I believe that this evidence coupled with positive results from the upcoming BRAVE-EPA study could be sufficient to warrant an new NDA. In light of decades of slow progress towards AD treatments I see the FDA becoming more accommodative towards the EPA safe solution.

What say you?