Amarin Corp Plc (AMRN)

[Laurent Maldague]

I can't help shake the feeling that Denner was timing his August purchases to the AHA late breakers and MITIGATE.

Back in January, this was what KM said about Germany:
" But at the same time, we found at least one precedent where there was a rejection, and the company came back with different data, like real-world evidence to demonstrate the value, and it succeeded. So, because we have this precedent we plan to pursue a similar approach."

MITIGATE is the closest thing to RWE for icosapent ethyl since the outcomes are 100% obtained by EHR. Check out this 2022 article that directly references MITIGATE
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9112643/
"Pragmatic RCTs can help to reveal the ‘real-world’ effectiveness of therapeutic interventions and elucidate barriers to their implementation."

FDA's definition of Real World Data:
Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status.
https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence


I don't think you can simply not disclose a clinical trial's results. FDA requires submission of results to clinicaltrails.gov within a year of the trial completion date.
https://classic.clinicaltrials.gov/ct2/manage-recs/fdaaa If Ambrosy doesn't intend to publish in a journal/present at a conference, the easiest way to be compliant would be to upload results back in July when he updated the entry in clinicaltrials.gov. My best guess is that he submitted to AHA latebreakers, but the presentation didn't make the cut in the appropriate category. Can't blame them, since the bar is probably a lot higher this time (PREPARE-IT2 and RESPECT were already latebreakers in the previous two years, so they'll probably prioritize others this time around).

Regarding what the results actually are for MITIGATE, I would guess probably inconclusive on the Covid endpoints, but significant reductions in some of the CVD endpoints (revasc/hospitalization for unstable angina). A big bonus to Germany would be what the LDL levels were as well (the lower the better since they complained REDUCE-IT LDL levels were not low enough.)

Anyways, IF Ambrosy/Amarin actually have the data, shouldn't be the end of the world not making the cut for AHA late breaker. Yes the presentation publicity is nice, but they really just need to get the results published in a reputable journal and soon.