![]() Or they might want to take on the fact that dietary supplement Omega-3's have repeatedly not worked, and want to emphasize that. I would say because we're talking about the first therapy in a patient population that's measured in the millions - potentially tens of millions of patient, and because there are some theses out there at, at least I could hypothetically come up with that the FDA might want to look at like such as emphasizing that the REDUCE-IT result is not a validation of triglyceride lowering, but rather what we studied is a patient population we elevated triglycerides and showed the multifactorial affect of Vascepa lowered cardiovascular risk, which we would agree with. Some people would say, well, why would there be an AdCom. They've not told us whether they are considering one, whether they're not considering one, or maybe.Īs a reminder, the sNDA that we filed with them was filed on late March, PDUFA date is September 28th, mid-cycle review is the 28th of this month, and while it is not without precedent for companies to be notified by FDA of an AdCom yea or nay before this, there is plenty of examples of companies being notified beyond this point in the review cycle, so Amarin continues to prepare for the potential AdCom. For those of you who have followed us for a while, we'll start with one comment which will be really the only update that I'll be providing here, which is the response to the question that I hear first from most investors today, the question of have we received any word from FDA with respect to a AdCom, and the answer to that is, no. Anybody considering investing in the company should review all risk factors and described in our SEC filings before investing. I will be making forward-looking statements in conjunction with this presentation. As an adage I tend to like the one over here, if you follow the data it leads to good things, and particularly when you're working with excellent people, but I am here to talk about Amarin. We look forward to hearing about all that, and thank you so much for being here. John has been at Amarin for almost 10 years, and CEO for the past five years, and I guess the old adage, patience is a virtue, couldn't be more fitting, considering the great results he got in the fall from the long-awaited REDUCE-IT outcomes study for your key product Vascepa, so congrats on that. President and CEO of Amarin, who'll give a presentation for about 15-20 minutes, I think, and then we'll follow-up with some Q&A. ( NASDAQ: AMRN) 2019 BMO Prescription For Success Healthcare Conference J11:20 AM ET
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