TIGER'S TAKE: On our watch list/trading list. We see this as a good longer-term health care play that provides some short-term trading opportunities. $AMRNAmarin rises as CEO sees FDA panel as opportunity to showcase resultsCEO John Thero says drug will cost patients with insurance coverage about $3 per day Shares of Amarin (AMRN) are on the rise after the company's CEO John Thero told Bloomberg in an interview that he sees the upcoming FDA panel as a "great forum" to talk about Vascepa. The advisory committee has been tentatively scheduled for November, in connection with its review of the pending supplemental new drug application for expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study. AMARIN EXPECTS APPROVAL BEFORE YEAR-END: In an interview, Amarin CEO John Thero told Bloomberg that a successful panel could lead to FDA approval and expand the number of patients Vascepa can be prescribed to before the end of 2019. "We have a drug that we think is safe and effective, and is approved today for a niche but an important indication. […] We are looking forward to promote this to a much broader audience and we see an opportunity with the upcoming AdCom to give a broader profile of this drug, and hopefully get an approval before the end of the year," the executive said. Thero also highlighted that an advisory committee is "pretty common" given the market opportunity. "For indications that are first of their kind, particularly for indications where the opportunity is very large, it's pretty common for the FDA to have an advisory committee. […] We were anticipating having an advisory committee meeting in August and we were ready for that, and now they’re having it in November. It will be an opportunity to showcase the results." The CEO also noted that the company has started to hire and train additional sales representatives ahead of an expected "robust" launch. Questioned about pricing, Thero said that, "From a pricing perspective, patients who have insurance coverage can get this drug for about $3 a day." ADVISORY COMMITTEE MEETING: Earlier this month, Amarin announced that it received notice from the FDA that the agency plans to hold an advisory committee meeting, tentatively scheduled for November 14, in connection with its review of the pending supplemental new drug application for expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study. Accordingly, the company said it does not expect the FDA to take action on the supplemental new drug application by the previously announced September 28 PDUFA goal date. It said, "In light of the tentative AdCom date, Amarin anticipates that the PDUFA date will be extended, assuming a typical three-month extension, to a date in late December 2019. If so, this anticipated revised PDUFA date timing would offset three of the four months that were expected to be gained from FDA's earlier determination to conduct a priority review of the REDUCE-IT sNDA. Prior to such determination, Amarin had expected a PDUFA goal date in January 2020, based on a standard 10-month review. Amarin plans to update the investment community after appropriately definitive information is available related to a new PDUFA date." PRICE ACTION: In afternoon trading, shares of Amarin have gained about 3.3% to $15.05.Source: (thefly.com) $AMRN, Amarin Corporation plc / H1 Disclosure: I may trade in the ticker symbols mentioned, both long or short. My articles represent my personal opinion and analysis and should not be taken as investment advice. Readers should do their own research before making decisions to buy or sell securities. Trading and investing include risks, including loss of principal. If you liked this article, please click the LIKE (thumbs up) button. Feel free to leave any comments, question, or opinions. (Sign-up if you haven't already done so). Follow us/bookmark us and check back occasionally for additional articles or comments on our page... Wild Tiger Trading - start/main page.