Jasbg, I feel the same way. The prospect of Amarin developing additional next-generation IP is tantalizing for sure. My hope was diminished after reading the 10k competition section where Amarin lists Afimmune as one of them. Upon the release of TLD, the board took a survey as to what a BO valuation would be by early 2021. I believe the avg mean was around $65. It's safe to say, none of us considered even the remote possibility, that an alternative drug, let alone one in the same category, could possess a superior capability. Having said that, IMO, the landscape is different today than it was then. As we near 2021, BP's are considering what acquisition prospects would deliver the most bang for the buck. How does the existence or perceived existence of competition effect BP's calculus, when or if, they're considering a BO of Amarin?
Nonetheless, it gives further comfort to see that Epeleuton is focused on NASH as well as additional Pulmonary ailments, not CVD! It's only hypothesis-generating for "possible" benefits for CVD, but that's not where they're focused. Keep in mind, that Epeleuton is required to conduct additional phase studies for the indications under study. What does that mean, obviously, if Afimmune is going to spend time for whatever amount of months/years to prove effective for these indications, in effect, it puts them "years" away from even beginning to conduct an outcomes trial for CVD. Keep in mind:
Amarin was "required to enroll a huge International population, which required a set number of events to occur. That enrollment process doesn't occur in short order. Also, the way EPA works, therapeutic effects aren't seen until 9 months and beyond. IMO, Afimmune made a smart tactical decision to take a path that hasn't been taken. Imagine running a Reduce-it like study, and in the end, the outcomes are not stat sig, or perhaps not enough to justify a higher cost to the patient, or it may not provide any advantage. Now that's BIG RISK. So instead, Afimmune is pursuing a substantial market share in these other indications.
In support of my better outlook for today's landscape, I am further comforted by this quote from Amarin's 10K from page 15 under competition:
Quote:
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our understanding that the FDA is not prepared to approve any therapy for the treatment of cardiovascular risk based on biomarker modification without
outcomes study data, with the potential exception of therapies which lower LDL-cholesterol. In particular, it is our understanding that the FDA is not prepared
to approve any therapy based primarily on data demonstrating the lowering of triglyceride levels. In our view, this position from the FDA did not change based
on the REDUCE-IT study particularly in light of significant independence of the positive benefit demonstrated in the REDUCE-IT study from triglyceride
levels and benefit from the REDUCE-IT study supporting that the positive effects of Vascepa are unique to Vascepa and extend beyond triglyceride reduction.
If the FDA were to change this position, it could potentially have a negative impact on us by making it easier for other products to achieve a cardiovascular
risk reduction indication without the need in advance to conduct a long and expensive cardiovascular outcomes study.
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