Thero's response to Michael Yee's question:
Michael Yee
Wanted to follow-up on your commentary on the European process. If I go back, maybe a year or so ago, when all the U.S. FDA filing and the review was going on, you said you had a lot of European interest and I thought you said, maybe it was a dozen books or so. But maybe just remind us about the type of interest that is out there in Europe, because I get the sense that a lot of big companies these days are maybe less interested in cardiovascular and much more just oncology. So maybe just frame how much interest is there by big pharma and frame what happens in the third quarter? If you look at these things and you accept one of them or you are going to announce in the third quarter that you're hiring your own sales force and if it's the latter is expenses for launching the sales force in Europe in the guidance? Thanks so much.
John Thero
So with regard to interest in VASCEPA by big pharma, there is interest in VASCEPA by big pharma globally and right now we're focusing on Europe, Europe certainly no exception to that. We've had multiple companies doing diligence and I'm not going to get into numbers of companies and it really talks about terms, but this is a multi-billion dollar opportunity for a differentiated product. And there's companies that might say they're not into cardiovascular, but they're into metabolic or they're into diabetes, and generally they're into growth. And so we're seeing interest as to whether those companies will put forth terms that we feel would be appropriate, given the size of the opportunity and the stage of where its act of simply de-risk from a clinical perspective and largely de-risk from a regulatory perspective, we will see. The decision that you're asking me about in Q3, yes, framing in Q3, so hopefully we’d be in a position to decide are we going direct or are we partnering and if partnering hopefully to announce the terms of that are, and if we're going direct of way to outline some guidance as to what that means in terms of what would undoubtedly be update of a bit of a sequenced launch with emphasis on some of the larger countries first, in mid to small countries later and whether we would do some of those smaller countries directly or potentially with partners -- would be potentially flushed out at that point in time. And at this juncture, while we’ve withdrawn on our overall guidance for the year, including our previous quantification of operating expenses and talked about our -- the prior spending guidance volumes being too high relative to expenses is a pull back on the U.S. DTC, for example, that earlier your spending guidance, included some money for Europe, but did not include money for a significant launch in Europe.
That being said with approval for Europe, that would likely be somewhere near the end of this year. The launch in Europe would most likely be for a next year event rather than a year event. So possible for this year, but you get too close to the holidays and things and it's often just better to wait further for the New Year, that would all be -- hopefully be built out when we make a decision. Again, at this point in time, we're just trying to let shareholders and all the parties know that we're evaluating and our aim is to do what is in the best interest of shareholders on a long-term basis from a holistic perspective.
