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Pirateescapee

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  • Chelsea: FDA Panel Meeting And Trading Strategies [View article]
    16-1 in favor. It will be exceedingly difficult for the FDA to issue a CRL twice with two positive panel votes without looking utterly stupid. However, that never seems to bother them.
    Jan 14, 2014. 05:21 PM | Likes Like |Link to Comment
  • Chelsea: FDA Panel Meeting And Trading Strategies [View article]
    There is a sustained response. If there weren't there wouldn't be a plethora of patients asking the FDA to approve. Quantifying subjective endpoints (dizziness questionnaire) statistically among a population of elderly infirmed patients creates problems in this regard. This has been discussed with the FDA and they have acknowledged the inherent problems associated with this approach.

    If you go from spending your life in a wheel chair to being ambulatory in the first week, incremental changes after that become more difficult to articulate as time goes on. Even with this problem, if you combine all the studies done, the stat trend is towards stat sig. The 401 study has been powered differently with the above problem in mind, i.e large population and much longer timeline.
    Jan 1, 2014. 05:26 PM | 1 Like Like |Link to Comment
  • Chelsea: FDA Panel Meeting And Trading Strategies [View article]
    Briefing documents are rarely written as an endorsement of any drug or therapy. They are written in order to ask the hard questions. The first set of briefing documents plainly stated that the reviewer did not recommend approval (at that time). The issues of concern were both safety and efficacy. Chelsea and the FDA have had a tremendous amount of interaction and exchange since then. It is clear that the FDAs stance has changed since then for the better. I would expect a tough review but one that has softened a bit with a better understanding of the issues. Chelsea will be better prepared this time around and will have a lot more data to use. Again, Adcoms are a matter of benefit vs risk. As a whole, I believe the scales tip in Chelsea's favor. There are no slam dunks in biotech and Chelsea is not guaranteed a positive panel or approval. I do however think they are armed and prepared to represent themselves well and that the FDA is willing providing they are able.
    Dec 31, 2013. 10:50 AM | 5 Likes Like |Link to Comment
  • Chelsea: FDA Panel Meeting And Trading Strategies [View article]
    Actually if you take the totality of the data from all the trials in meta analysis, the durability of efficacy is trending positively. In addition the dizziness score/endpoint is inherently subjective and difficult to quantify past week one, where the majority of benefit is "felt". Finally, many of the patients/questionnaire respondents are elderly and sick and have problems with the dizziness score questionnaire. The FDA understands this and has acknowledged this in meetings with Chelsea. Hardline statistics do not tell the complete and important story. Patient testimony does. It swayed the first panel under much more difficult review circumstances. Many of the questions surrounding the first review have now been answered. This review will go smoother. The latest study is now powered and designed with the above in mind.
    Dec 31, 2013. 10:10 AM | Likes Like |Link to Comment
  • FDA Reviewing Panel Comments In 9-2 Vote [View instapost]
    Not sure who you spoke to. My only hope is that it isn't the same individual that had been on a panel and predicted a slam dunk for Vascepa and that the affair would be over by noon.............

    I'm not writing this to be contentious, its simply that the amount of people who have been wrong about Amarin could fill stadiums and I'd fill one of those seats.
    Oct 22, 2013. 02:10 PM | 6 Likes Like |Link to Comment
  • AMRN: Does The FDA Need To Be Investigated  [View instapost]
    Ralphy - Quick question. What sort of dialogue is going on between doctors in your circle concerning the Amarin/FDA situation and Vascepa in general ? I guess I'm trying to gauge whether or not there will be any effective or substantial support to reverse this situation from doctors/medical professionals.
    Oct 21, 2013. 08:35 PM | 1 Like Like |Link to Comment
  • Adcom 2-9 Against Label Expansion [View instapost]
    Good luck with that. The reviewer is but one person within the FDA but it is FDA itself which seems to want keep Amarin out of the mix. Either this is specific to Amarin or the FDA is shifting policy,... period.

    If it is the former than we have a real problem with outside influence and a corrupt process. If it is the latter then the FDA is very short sighted and it is possible with enough stink that some sort of compromise can be reached in the interest of drug research and development and plain common sense and fairness.

    Regardless, getting into a protracted legal battle or behind the scenes pissing match isn't likely to go in Amarin's favor. Its more of a case of appealing to peoples common sense and decency, highlighting the unintended consequences of the FDA stance etc. You can't do that if you're stepping on toes.

    In the meantime, Amarin can't be in a perpetual "quiet period" with its shareholders.
    Oct 17, 2013. 03:16 PM | 4 Likes Like |Link to Comment
  • Adcom 2-9 Against Label Expansion [View instapost]
    Steve - The big question is how do we get there from here? I'm thinking a partnership but I'm not sure whether that ship has sailed or not. Your thoughts?
    Oct 17, 2013. 01:06 PM | 1 Like Like |Link to Comment
  • Adcom 2-9 Against Label Expansion [View instapost]
    Sure as hell screwed AMRN! AMRN committed themselves to a very lengthy and expensive outcomes study and took on debt to hold up their end of the bargain. In addition, any and all decisions for commercialization were predicated upon that agreement with the FDA. That is what makes me feel that the FDA is compromised. That knew that changing the playing field would give AMRN one way out.

    Unless this is resolved, the FDA has set a precedent that casts a real shadow over the world of biotech. Asking companies to spend millions on Phase 1,2,and 3 trials and then forcing them to complete outcomes studies before having a chance to market their drugs will put a real chilling effect into play. It is counterproductive and untenable for both companies and investors trying to bring new therapies to market. This approach also fails millions of patients that would benefit from these therapies.

    If we are to hope for real cures for CVD, this was not the way to do it.
    Oct 17, 2013. 12:14 PM | 3 Likes Like |Link to Comment
  • Adcom 2-9 Against Label Expansion [View instapost]
    Ringbellplease - Lots of pain and frustration to go around here. Alot of people got hurt. Some very badly. Myself included. I'll make it as I always do but alot of hopes and dreams evaporated in what appears to me to be a very unfair decision. I have no one to blame but myself.

    I believe in the science and that ultimately AMRN will be vindicated. The real question now is how does AMRN get from here to there. I sincerely hope that Steve and others with meaningful input continue to voice their opinions and share their knowledge. Good luck to you.
    Oct 17, 2013. 11:56 AM | 3 Likes Like |Link to Comment
  • Adcom 2-9 Against Label Expansion [View instapost]
    Yes Steve was wrong but so were all the analysts, institutional investors and retail investors who were bullish on AMRN. Collectively,that represents a whole lot of very educated and smart people.

    Piling on now is a classless thing to do. Give it a rest. Nobody who has invested in equities is immune from getting it wrong. The deciding factor in this case was a governmental agency who moved the goal posts, for no viable reason. It appears to me that the fix was in.

    Amarin needs to partner. Now.
    Oct 17, 2013. 11:07 AM | 6 Likes Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    Guess we'll have to wait and see, lol. Given the bad rap Amarin has continually received for NOT communicating with shareholders, it is funny to see that the simple scheduling of a CC has everyone looking for hidden meaning. Despite access to the Adcom proceedings there will no doubt be much the company has to say and lots of questions from analysts and investors alike.
    Oct 9, 2013. 11:49 AM | 2 Likes Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    Amarin ought to move on this study. Fresh in the news
    "Massive DNA study points to new heart drug targets and a key role for triglycerides"
    http://bit.ly/17QWqNh
    and
    "New study gets to heart of triglycerides’ role in coronary disease"
    http://bit.ly/17QWooy

    So who led the study? Sekar Kathiresan.
    Kathiresan is the current Director of Preventive Cardiology at the Massachusetts General Hospital (MGH) Heart Center and an Associate Professor of Medicine at Harvard Medical School. He received his B.A. in history summa cum laude from the University of Pennsylvania in 1992 and received his M.D. from Harvard Medical School in 1997. Kathiresan completed his clinical training in internal medicine and cardiology at MGH. He served as Chief Resident in Internal Medicine at MGH in 2002-2003

    I know I know..........you thought maybe Adam Feurstein led the study, but you were wrong.
    Oct 8, 2013. 03:30 AM | 1 Like Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    Cystic Fibrosis potential patient population in the US = 30,000
    ANCHOR potential population 36,000,000

    Average lifespan of a cystic fibrosis patient 37.4 years.

    I can see why the FDA might waive a panel in this situation.
    Oct 4, 2013. 01:27 PM | 3 Likes Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    The real question to be answered here is why does the market believe the panel will say no? I have my own theories, such as
    1. A lack of wide spread understanding of the difference between Vascepa and fish oil.
    2. A lack of knowledge as respects what Vascepa does in concert with lowering trigs, i.e lowering inflammation biomarkers etc.

    I think the panel meeting will shed light on these issues and clear up alot of things.

    How about you? What do you think?
    Sep 30, 2013. 06:59 PM | 2 Likes Like |Link to Comment
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109 Comments
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