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  • Amarin's Constellation Of Possibilities Defy The Fall Of Night [View article]
    Scrying Biotech,

    Please check out this citation linking Dr. William Hiatt to Astrazeneca...

    Dr. Hiatt is very very enthusiastic about this drug..a competitor..Why was there no conflict of interest disclosed at the AdComm?

    ":>) JL
    Apr 17, 2015. 08:23 AM | 2 Likes Like |Link to Comment
  • Amarin's Constellation Of Possibilities Defy The Fall Of Night [View article]
    Scrying Biotech...

    You might to increase your insight into Dr. William Hiatt by reading the article he authored in the NEJM

    In this article, he actually includes his own ridiculous comments on Vascepa's potential to cause bleeding and diabetes. Since he is the author, these comments come off as something everyone at the AdComm acknowledged. Truth was the comments were easily repudiated. If you actually went back and viewed the morning session of the AdComm you would see this.

    I am disappointed you have not posted something on your reread of the AdComm. Disappointment is frequent condition if you are pulling for Vascepa. We need strong objective writers like you to delve further than the superficial. The truth is there and needs the light of day, not the darkness. Light always prevails over darkness.

    ":>) JL
    Apr 17, 2015. 08:11 AM | 1 Like Like |Link to Comment
  • Amarin's Constellation Of Possibilities Defy The Fall Of Night [View article]
    A note on your addendum on Dr. Hiatt.

    You might wish to go to the earlier portions of the AdComm to see Hiatt in action. Hiatt is a "One Eyed Jack" and earlier we see the other side of his face as he is attacking ANCHOR by deliberately misconstruing the safety data regarding both the statistics on "bleeding", and diabetes. These two parameters had already been declared a non issue by the FDA, but Hiatt threw in enough mud to clog the sink. The effect on the passive and for the most part, uninformed, other AdComm panellists was to heighten their concern over safety. This was an obvious hatchet job as his points were ridiculous to those fluid in statistics and diabetes.

    Later in a scene reminiscent of Hamlet reading Lewis Carrol's poem "the Walrus and the Carpenter"...He professes his concern about the integrity and consistency of the FDA...

    Later he wrote a snuff article for the NEJM on Vascepa..

    Hiatt is a paid stooge, hit man for the cartel.

    ":>) JL
    Apr 14, 2015. 04:19 PM | Likes Like |Link to Comment
  • Amarin's Constellation Of Possibilities Defy The Fall Of Night [View article]
    Scrying biotech...

    Wonderful article ....dead on...Lengthy, appropriately so, because the subject is complex in a Byzantine way and explanations are needed. Coincidentally, earlier today I posted on the AMRN Ihub board the question of whether in eighties the government decided to go after the wrong drug cartels. Perhaps we need to exhume Kefauver and call for congressional investigations of the FDA's relationships with BP. There are lives in the balance.
    AMRN certainly has the representation to go against anything the FDA is going to go to court with. C&B, Amarin's lawyers were rated the number one litigation firm in the nation by Lawyer Magazine in 2014. Like to see how the FDA dreams up a defense against the SPA hatchet job by "science" not seen since the time of pope Urban VI in the fourteenth century..

    Do not agree with the ending as you propose. High efficacy is not going away, and the FDA or their handlers are not going to stand in the path of a tornado..Science always prevails, the reign of Urban VI did come to an end. Eventually all the foul odors seep up out of the ground.

    ":>) JL
    Apr 13, 2015. 05:32 PM | 1 Like Like |Link to Comment
  • Amarin: The Silence Of The Lamb [View article]

    Agree and have opined earlier that dropping the FDA appeals makes no sense unless something substantial is being offered by thr FDA. Thero's explanation of why they dropped the FDA appeals process makes no sense. He said communication from FDA higherups indicated they were not going to change their minds. The reason for pursuing the FDA appeals process was not some misguided hope the FDA was going to change its mind. Once the appeal at division level was denied, there was close to zero chance the opinion was going to change, because the opinion was coming from above.

    The reason for pursuing the FDA appeals was the necessity of completing the FDA process to qualify for the federal claims court requirement which was to exhaust all remedies before seeking federal relief.

    Pursuing the FDA process would not be a big deal. Forfeiting the federal option is a very big deal. If they gave this up without something substantial from the FDA, then they qualify as fools by the full definition.

    IMO Amarin best chance for relief would be the courts. I have been very disappointed by the FDA decision regarding the SPA, but from my reading and observing I am more inclined to drop my opinion of the FDA acting out of pure evil, to a more banal notion that the FDA and their "experts" are simply ignorant and indolent of the true facts relating to heart disease. Not at all the experts they should be. A medical community which is likewise either due to information overload, or lethargy, is unlikely to come to Amarin's defense. The best chance is in federal court, where the judge can and must review the facts that led to the SPA and the facts used to break the SPA. I would not like to be on the FDA's side in this case.

    ":>) JL
    Dec 2, 2014. 01:53 PM | 1 Like Like |Link to Comment
  • Amarin: The Silence Of The Lamb [View article]
    I posted, (on AMRN iHub) after the amazing declaration that Amarin was not planning to continue the appeals process, that this could be the result of some sort of offer from the FDA. My reasoning was somewhat different from SB's.

    The reason Thero gave for dropping the appeal was they had communications from the higherups in the FDA that they were not planning on changing their mind about the SPA. Well that is no reason at all. The purpose of pursuing the appeals FDA process was not to get the FDA to change its mind. After the appeal at division level was turned down, the rest of the FDA's actions were predictable since there was a zero chance the FDA high command had not approved the denial. The reason for pursuing the FDA appeal to completion was to enable the company to file in federal claims court. So by giving up the appeal they are forfeiting (at least for now) a bite in federal court.

    The cost of continuing the FDA appeal is negligible, and the forfeiting the federal option is a very big if they are not getting something from the FDA, then the meet the true definition of fools.

    Pursuing this further (sorry)..I do think this is plausible. IMO the FDA's case is weakest in federal court. I do qualify as a disappointed shareholder and feel the FDA made a terrible decision in the Amarin SPA, but all my reading and observing has lead me to the conclusion that the FDA's actions may not simply be "evil in action", more likely they are the mundane actions of people, FDA personnel and clinical doctors, some professors of cardiology, who are not really the experts they claim to be, who lack the depth and reach of knowledge to understand that CVD my involve more than elevated LDL-C.

    In a federal court there will be a judge and he will have to consider all the scientific and clinical evidence that went into the making and breaking of the SPA..I know that if I was sitting in the FDA's position, I would not be comfortable with this..

    ":>) JL
    Dec 2, 2014. 12:12 PM | 4 Likes Like |Link to Comment
  • Amarin: REDUCE-IT And Debt Analysis Confirm That The Current Share Price Is An Opportunity [View article]
    "Any result achieved months earlier than expected is probably bad news..."

    That seems to be general consensus, but I feel differently. The people who monitor the trial will be on the look out for lower than expected event rates for the entire R-IT enrollment. This is very likely if the rate reduction in the V arm is above 40% which I am convinced it will be by mid 2015, the trial will stopped then for safety concern in the placebo group.

    I will expand on this on the Ihub board later this weekend.

    ":>) JL
    Oct 11, 2014. 09:46 AM | Likes Like |Link to Comment
  • Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar? [View article]

    "Will the doctors ........based on freedom of speech?"...ans:..can a fat hog see his azz on a foggy day?"

    This article raises fifty shades of grey. First off if the company opts for the federal court option; the question is whether to attack the SPA rescission or the first amendment issue. The SPA agreement embodies the requirement that in case of a default on the part of the FDA the sponsor Amarin must appeal unsuccessfully to 5 separate progressive FDA levels before it can seek remedies in the courts. If Amarin fails to do that the federal court will return Amarin to FDA and Amarin may be restricted in using some of the material it used in the court presentation.

    At present Amarin is at late level 3, and could go before the court in six to nine months. This might be a better strategy than first amendment. Amarin could lose first amendment, because the FDA might argue medicine and authority which can be twisted, and obfuscated. In this type of situation the court is more likely to give leeway to the FDA whose job it is to protect the public. The FDA needs to make the situation confusing enough that the company can not prove that the FDA is simply "doing its job". The court is going to need strong evidence before depriving the FDA of its function.

    The SPA argument puts the FDA on much less solid ground. The SPA is nothing more than a contract between two parties. The federal court understands contracts. Ruling against the FDA here will be no big deal. The SPA agreement is a de facto quid pro quo agreement that the sponsor Amarin will design and carry out an expensive FDA approved clinical outcome trial. Upon about 50% enrolment in the trial, the trial will be considered "substantially underway" at which point the FDA will give the sponsor a valuable franchise to sell drugs to the mixed dyslipidemia cohort (estimated 35 mil)...

    As long as Amarin performs, the only way the FDA can legally end the agreement is if a substantial issue arises concerning either the safety or efficacy of the drug is identified after commencement of the trial. Substantial in this case would be considered something significant enough that both parties would agree the continuation of the trial would be senseless. This here is not the case. It is clear that the FDA "changed horses in the middle of the stream". The FDA has acted poorly in this case, by delaying in informing Amarin of its change of heart until close to midnight. The FDa's arguments are pathetic and do not reflect FDA procedure, method or logic...The FDA lawyer have to know at this point that there is little chance of winning this in court. I believe the FDA will in the not two distant future announce they are reinstating the SPA agreement...Going to court is much too dangerous for the FDA

    ":>) JL
    Jul 21, 2014. 11:15 PM | 7 Likes Like |Link to Comment
  • Stagnant Sales An Ominous Sign For Amarin [View article]

    "No real longs (meaning those has had shares since a couple years ago) will consider any possibility of its revival." What are you talking about, there are many of us from over three years ago who still are very optimistic about AMRN...

    Who are you by the way ?...Never heard of you..

    ":>) JL
    Jun 12, 2014. 11:50 AM | 3 Likes Like |Link to Comment
  • Stagnant Sales An Ominous Sign For Amarin [View article]
    Nice jab job Big A.

    So you figure KOWA after a couple of days on the job is a bust. Makes perfect sense to me..

    ":>) JL
    Jun 12, 2014. 11:46 AM | 7 Likes Like |Link to Comment
  • While Amarin Continues To Go Rancid, Neptune Will Soar [View article]
    Krill Oil...

    I invested in NEPT in 2011. Krill oil from the study in The Journal of Alternative Medicine seemed almost too good to be true. Even thought Krill Oil contained EPA and DHA in approximately the same ratio and percentage as fish oil. Krill Oils omega-3s seemed to be much more effective at lowering trigs, non HDL-C, and yes even LDL-C although all other EPA, DHA mixes actually raised LDL-C..

    So I did a little investigating and decided to check the lipid results against the Friedewald Equation. The Friedewald equation is an clinical formula which has been proven in a clinical study involving 29,000 patients at the Brigham in Boston to very accurately describe the relationship of blood lipids including total-C, HDL-C LDL-C and trigs under 500mg...Guess what? The results of NEPT's study did not conform to the Friedewald equation..Furthermore all the resulting errors in the study result were in favor of the idea that Krill Oil was in some way superior to fish oil..Conclusion..the trial results were fudged.

    Krill oil is just expensive fish oil. Let them run a real trial supervised and monitored by the FDA.

    Go buy NEPT if you want to..Not the way..Krill oil is about the most likely of all the oils to go rancid..You should read up on how hard it is to process.

    ":>) JL
    Jan 15, 2014. 02:25 PM | Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    Dear Jane,

    Thnx for the response..I am familiar with the continuum that exists in blood lipids, that VLDL contains LDL-C and the LDL carries trigs and there is conversion of VLDL into LDL and so on. I also am familiar with the CVD risk factors and understand why LDL-P is a better risk predictor than LDL-C.

    These lipid facts are interesting, but IMHO must take a back seat to inflammatory issues. I am convinced that most people could live long and prosper with terrible lipids, including LDL-Cs, trigs, remnants, CMRs, the works, provided their systemic inflammatory levels are low enough. Also if your inflammatory levels are high enough, you are probably at at high risk even if your lipids are normal..CVD is an inflammatory condition effecting the arterial system. Lipids probably do serve as agents which aggravate the situation. Trigs, because of their relationship to diet actually increase inflammation.

    I understand the FDA is not looking at it from my point of view. I also understand your point of view on the FDA's attitude toward ethics and the law. It's sad but I have to agree. In this case I can not agree with you on the SPA's final disposition. Events currently playing out are going to put a lot of pressure on the FDA and an SPA agreement does not provide the FDA the wide latitude it is given to decide routine labeling. If the FDA is bold enough to stonewall this farce, the matter will soon be before a federal magistrate. There is some current information regarding FDA insider trading (bad enough), but also inappropriate communication between a hedge fund and FDA officials. The FDA is clearly under the scope at present..Lets see how this plays out..

    Good luck... ":>) JL
    Jan 5, 2014. 10:14 AM | Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    Dear Jane,

    I confess I did a little background check on your earlier posts on SA.
    Since you seemed to be interested in the level of medical or other forms of education, I am a graduate of MIT (ChemE) and from Harvard Med...

    Learn the science first? You seem to be confused by what you are writing. Let me try to summarize. You mention one problem with trig evaluation, is lipid measurements show dependencies and relationships, the most famous is the Friedewald Equation. Trigs tend to show a predictable inverse relationship with HDL, (FYI APO is not inversely related to trig levels, because VLDL (the trig carrier) contains APO). Your point about the relationship of trigs to HDL, is that since HDL is an inverse CVD risk factor, then if trig lowering raises HDL, then the improvement in CVD risk attributed to increased levels of HDL must be subtracted from the trig lowering, because it is not independent of the HDL rise. This is correct.

    The association of trigs and T2DM is duly noted. There is a chicken or the egg argument, but do not throw the baby out with the bathwater. Insulin resistance (IR) is the calling card of T2DM and it is well know today that IR is a product of elevated systemic inflammation, and not vice versa. One of things being uncovered by research on control of inflammation is the importance of diet in setting systemic inflammatory levels.The factors that raise blood trig levels also raise inflammation. So elevated trigs are not likely to be caused by an epiphenomenon of IR. In fact the situation is reversed.

    Yes hydrolysis of VLDV does lead to increase of atherosclerotic inducing remnant particles. Another reason to lower your trigs.
    In regards to the case controlled studies. They showed that pts with elevated trigs were 3x more likely to show the small dense low-density LDL particles which are known to increase CVD risk more proportionately than LDL-C. The comment being, "Overall data from case-controlled studies have supported triglyceride level as an independent risk factor.!!!
    The last pargraph is simply a rewarmed version of the first paragraph that states the well known fact that lipid measurements are related to each other.This is not say that from an etiological standpoint that trigs might not be the most important of the group. At best there is some uncertainty about the role of all the lipid components.

    I believe it is you who are confused. These citations do not tar trigs. The terms of the FDA's SPA agreement do not state that Amarin must present a case where uncertainty over the results of REDUCE-IT do not exist. If there was no uncertainty, then why run the trials? The FDA to legally  rescind the the SPA, must present a substantial new scientific issue which would call into question the safety or efficacy of the drug. There is no doubt if such an issue existed, it would have to be of such significance that both parties would agree that the REDUCE-IT trial was a waste of time and money, because the drug was too dangerous, or could not possibly work. This is not the case here the FDA or the medical community has not suggested the company drop the trial The substantial issue is not just because Mary Park's aunt Irma does not believe trig lowering is unimportant, or for that matter a bunch of stooges lined up by the FDA to give the answer they want.

    ":>) JL
    Jan 4, 2014. 01:34 PM | 5 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]

    Question, is texasbucks your real name?

    The site allows both the authors and we posters the option of privacy. The doctor who posted the article is a nationally recognised medical authority. Perhaps his message would gain credibility if he posted under his own name, something that SA encourages, but academics frowns upon any foray outside of peer journals.

    Your advice on lifestyle is accurate, but does not jive with reality. People understand they should eat less, and exercise more, but saying and doing are different things..Check out the rise in T2DM and should, you will be picking up the bill for it. In this case the FDA is not approving a drug that will make doctors richer..Most likely not approving this drug is going to help some doctor's wallet. FYI, the fruits of BP do not drop on most MDs.

    You sound young, and sound like you did not lose too much here..Why the interest? Win a couple of bucks going the other way..Don't worry your number will come up if you hang around biotechs, then you're going to find out if you are really the tough guy you think you are..

    ":>) JL (not my real name)
    Nov 19, 2013. 10:53 AM | 19 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]

    Actually mineral oil was being administered in the 2 gm EPA group, it was 4 pills for everybody, --the 2gm group got two 1gm EPAs and two placebos. So if the mineral oil was causing the LDL-C rise then you would expect say a 1% rise from the EPA and 4.5% rise from the mineral oil, or about a 5.5% rise in th 2gm EPA group. So you might want to rethink things..

    That said, I could not agree more with you when you say LDL-C is vastly over rated as a risk marker..The fact the FDA and its henchmen were all towing the the LDL-C line shows us how far the statin business has perverted this agency..If there is an investigation it should start with the statins..

    The real issue and rationale for EPA is the fact that atherosclerosis is not a lipid disorder, but a chronic inflammatory disease of the arteries..EPA's therapeutic benefits reside in its ability to counter the effects of our diet which is too high in omega-6s and fast acting carbs (sugars)..The best evidence is contained in the large population studies measuring population CV risk vs EPA/AA ratios..

    You sound like a smart guy...Why don't you bone up on this information...EPA could do a lot for the USA we could use a guy like you..

    Disclosure...I am physician who is a part time adviser to research scientists working at Harvard Med/Dental School on novel methods of controlling inflammation..I am also in private practice in the Boston area..and am long AMRN.
    Nov 19, 2013. 08:54 AM | 15 Likes Like |Link to Comment