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Amarin Corporation plc Message Board

studythosestocks 1 post  |  Last Activity: Aug 23, 2014 9:00 PM Member since: Sep 29, 2010
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  • studythosestocks by studythosestocks Aug 23, 2014 9:00 PM Flag

    Commentary on Sunesis and thoughts on Phase III study
    Probable percent of life expectancy increase with the Qinprezo and Cytarabine combination. Things we know:
    Interim analysis ended in the promising zone. Even though management does not know exactly where the interim results fell since double blinded to them, they do know what the parameters were that they and the FDA agreed on going into the Valor Trial. What management continues to say is that they do not know EXACTLY or PRECISELY where the results fell in the promising zone. They do know however what that zone is. They just have refused to give the general public information on what this promising zone agreement with the FDA is. I personally have it falling in the 26-28% range as most likely but not below this range. One of the reasons I believe it could be in this range is that after the interim analysis, management did not increase the study from 450 to 675, they increased the study from 450 to 711. When questions were asked about this, it was basically blown off with minimal comments from management. The bottom line given is that they always had this as an option at the interim unblinding. However, until the unblinding, it was never mentioned that I remember. Also, it is not easily accessible to see that the study went from 675 patients to 711. This isn’t necessarily a bad thing but is strongly suggestive that this is another opportunity to raise statistical power if the promising range is closer to the 25% range than the 30% range. Either way, it is an excellent strategy by management to make sure that we have a p value at .05 or lower.
    What is considered positive results? This is up for debate. I have followed this company for many years and have tried to listen to each investor conference. I also have tried to do a fair amount of research on what the medical community determines “significant”. Although 40% would be a grand slam, this is not going to happen IMO. Although 30% or greater seems to be the “standard” acceptance from the medical community, I have also heard Adam comment as well as several well respected oncologist who believe anything at 25% or higher with statistical backing is significant. When you think about going from 4 ½ months or 5 months with cytarabine or going to 6 to 7 months with the combo therapy may not seem like much but someone fighting for their life the extra month to two months may be the difference of successfully receiving a bone marrow transfusion or not. The saving grace with Qinprezo is that the 30 day and 60 day all cause mortality rate is comparable to cytarabine by itself. 30% will be excellent, 25% doable, below 25% may be a hard sell. We may have some issues with managed care if in the 25-30% range however. I honestly am not qualified and have not worked up the scenarios in this area yet.

    Is patent protection and FDA approval secure? We have excellent patents in place and also have a fast track designation also to help protect us. Only concern is with Comp of Matter but we have enough other patents which should make it extremely unlikely for someone to successfully take generic Vosaroxin to market. We’ve botched a few things in Australia as far as patents go but we still may have a favorable ruling from the courts in this area. I have not researched it but “heard” that we also are in good shape in South Korea. Take this strictly as rumor since I have done nothing to prove this up. I don’t anticipate problems with FDA approval but the FDA has their own agenda. If they ask for an Advisory Committee then it will be a bit of a red flag but not a death sentence for sure. I don’t think Sunesis has burned any bridges to get on their side. European approval in the bag also.
    Value of Sunesis with approval of Qinprezo? Everyone will have their own value for the company. My studies show that we probably are closer to peaking around $400MM in US and $200MM for Euro for peak sales for Qinprezo ONLY for Relapsed/refractory cases is $600MM. This does not figure any future revenue for combo decitabine/qinprezo for frontline AML or any MDS capital. Figuring a company at 2-4X peak sales and that we will have 75 MM shares with all options and warrants exercised would give us a wall street price of $16-32 SP and this is conservative IMO. This would be our worth after FDA approval and estimated sales figures justify this possible peak sales. I’m not going to guess how the markets react with positive data release but I think we go over at least $15 with shorts covering. Possibly considerably higher.
    Release of Data? Maurice IMO is right on the money. Follow that thread and all the details are there. I don’t see a need to rehash their valid points. Back in the early part of this year at one of the investment conferences, Dan was asked when he felt that data would be roled out. The person interviewing and Dan basically said that a perfect scenario would be to role out results at ASH where they are in their own city on their own turf with great results. According to Eric, it takes “several weeks” to scrub the final data. EOM. Back to my thoughts, The data should be processed and submitted to the DSMB by end of August/early September at the latest.
    If approved, where do the pitfalls lie? Mostly IMO with the cost to ramp up their own sales team and whether managed care will jump on board to pay the prices that Sunesis believes that they can get for Qinprezo. Unfortunately, the young lady on the last conference call brought up some very legitimate concerns. I do believe that Sunesis has an excellent management team however but it will be an uphill fight IMO to get the pricing they believe that they will get. Also, a buyout of the company will be difficult with the “poison pill” structure that Sunesis has in place.
    Just as a side note, I have been an investor in Sunesis for an extended period of time. My goal was to accumulate an X amount of shares by March of this year but because of an FDA decision concerning a cardiovascular drug which was put on hold that I owned, I unfortunately never could reach my goal or even coming close. I also own a handful of Jan 17 2015 options. I have neither written this to “pump” the stock or to falsify where I believe the company is currently. I simply have written this to give my honest viewpoints of the company. It is unlikely that I will be financially able to add considerably to my position before unblinding but I certainly will not be selling one share I own until after unblinding. Hope this helps anyone looking into this company. Please do not take offense if I don’t respond to any comments. Unfortunately life right now is a little nuts. GLTA.

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