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  • Amarin: How The Co-Promotion Agreement With Kowa Affects Required Sales Targets [View article]
    Hi Elephant, good article. One precision: the fees that Amarin will have to pay to Kowa are based "on a percentage of Vascepa gross margins that increases during the Agreement's term". Actual annualised gross margin is $25M. So, Amarin will have to pay a little less that what you have calculated. For your example for 2018, if Amarin had sold 2,000,000 TRx which gives a gross margin of $192.5M, with Kowa, they need to sell 24.5% more TRx and not 28% like you have calculated it.
    Biwatch
    Apr 1, 2014. 03:00 AM | Likes Like |Link to Comment
  • Amarin: Today's Market Is Underestimating The Probable Success Of REDUCE-IT [View article]
    The SPA has been amended in May 2013 to modify qualifying TG to 200 to <500 mg/dL. Before this amendment, 4500 to 5000 had already been enrolled with a median TG of around 200 mg/dL (from the slides of the Adcom, AMRN mentions 2 numbers but not with precise dates: they write median TG is 202 mg/dL but they also write that the median TG is 230 mg/dL since amendment). It means that 2250 to 2500 patients will have TG <200 mg/dL. Will the group 150 to 200 be separated, I don't know. But suppose that we would have 2400 pts with TG<200 and 5600 with TG>200 and the RRR of CV events would respectively be 10% and 20%. The RRR for the total population would then be 17%.

    Biwatch
    Dec 17, 2013. 03:07 AM | 2 Likes Like |Link to Comment
  • Pozen Investors Get Cash, Wait For FDA Update [View article]
    Hi Jason,

    First, thank you for your analyses which are always valuable.
    I like POZN because I think the management really works to add value for the shareholders.
    But, I am a little afraid about the approval of PA.
    In fact, the FDA seemed to have request a teleconference to discuss the existing clinical pharmacology data on PA8140.
    My problem is that in August 2012, the FDA had said to Pozen that they did not agree that bioequivalence of PA32540 to enteric-coated (EC) aspirin 325 mg was demonstrated and in a type A meeting, they suggested to POZN that a bridge could be made with PA8140.
    Now, should they have problems with PA8140, what would happen?

    For info:
    On 8/1/12, POZN said "Following its preliminary assessment of the bioequivalence study data (115 study), the FDA informed the Company that, based on the information available, it did not agree that bioequivalence of PA32540 to enteric-coated (EC) aspirin 325 mg was demonstrated in such study..."
    After this, POZN had a type A meeting with the FDA and POZN came back with info on 8/23/12: "The FDA confirmed that, although the Agency believes bioequivalence of PA32540 to enteric-coated Ecotrin® 325 mg, the Reference Listed Drug (RLD), was not strictly established in Study 115 according to the predetermined criteria, the results from Study 115, together with additional information that will be submitted in the NDA, constitutes sufficient data to support the establishment of a bridge to Ecotrin® 325 mg under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. The FDA will make a final determination during the NDA review...The FDA also indicated that a similar strategy to bridge to the RLD under Section 505(b)(2), inclusive of a new, single pharmacokinetic study, could be utilized for a low dose version of PA32540 (currently, PA8140). "
    Nov 25, 2013. 08:53 AM | Likes Like |Link to Comment
  • Optimistic on Titan - Initiating Coverage With Outperform [View article]
    Hi Jason. Another excellent report. The molecule (Buprenorphine) is really wonderful. I understand the advantages of the 6 month dosing of Probuphine but I still wonder if an addict won't prefer to take a drug every day. At least for a first period of a few weeks to a few months.
    Concerning the use of Probuphine for chronic pain, it could be a nice competitor for Butrans (= 7 days patch). But there again, I wonder if I would not prefer a daily drug. It's more flexible and allows to titrate up and down.
    Jun 3, 2011. 06:19 AM | Likes Like |Link to Comment
  • Avanir Pharmaceuticals: Compelling Short Sale Opportunity [View article]
    You say you are patient but times plays against bears. Repo rate (= interest rate that brokers ask to keep a short position) is around 60%. At this level, if you hold your position for 1 year, it will cost you $4,5*60% = $2,70 per share! You shorted @ $4,20 but what is the amount of interest you have already paid?
    Jun 1, 2011. 03:58 PM | Likes Like |Link to Comment
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