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butters301

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  • FDA To Amarin: 'I Said Good Day, Sir!' [View article]
    Mr. QTR, can you please explain to me why their own regulations do not apply to Anchor and courtesy not given to Amarin? Anchor by design, is not supposed to prove CVD prevention. It is what it is, a better version of TG lowering drug compared to all others already approved. This is a section from the New Yorker regarding FDA recent approval on a pain drug despite a negative adcom recommendation:

    "...a company that wants to market a new drug must test it and submit evidence to the FDA that the product is as safe and effective as another drug in the same class that has already been approved. Also, the drug's health benefits are supposed to outweigh known risks. And the company must show that there is no new "signal" that the drug presents a health risk above and beyond the general problems endemic to its entire drug class. In other words, to be approved, a drug does not have to be better than drugs that have been approved in the past. It just can't be worse. If the drug fails to meet these qualifications, the FDA can take regulatory actions, for instance- requiring more tests or better labeling- or it can simply decide not to approve the application. But what if the new drug has a problem that is known to exist throughout the entire drug class? In that case, the FDA cannot simply refuse to approve the new drug."
    Jan 21, 2014. 04:36 PM | 1 Like Like |Link to Comment
  • Amarin's Anchor Gamble Sends Stock Up 20% On 'No News' News [View article]
    Mr. QTR, first of all, Anchor is not a gamble. Omega-3 benefits have strong scientific supports. The FDA is the fishy one starting with NCE non-decision for over a year. Secondly, one should question why Amarin stock has been dropping on every good news since approval.
    If you really use your brain and want to help people, you would see the undeniable benefits of Vascepa and what it can do to help millions of Americans suffering from CVD, whether you're aware of its progression or not. If you don't reduce your risk factors, it may be a time bomb waiting to go off someday. It is our #1 killer and the use of statins alone has not shown to reduce that number.
    The new 2013 AHA guidelines never mentioned anything about TG levels being insignificant. As a healthcare provider, and many of us, will continue to promote omega-3 and recognize all risk factors contributing to CVD including high TG levels and atherosclerosis until it's officially removed from our textbooks or PDR (if that's the new FDA position). Please look under Lipitor indications and usage and its target patient population. That is what Reduce-it is all about. The AHA did not say ignore the lipid profile or lowering TG is meaningless (Anchor). It suggests we evaluate and approach treatment by assessing overall risks and the use of statins PLUS any necessary measures to diffuse your time bomb. It's about prevention, not speculation.
    Dec 21, 2013. 03:51 PM | 3 Likes Like |Link to Comment
  • Amarin's Anchor Gamble Sends Stock Up 20% On 'No News' News [View article]
    I agree david with everything you described. The entire scientific community recognizes the benefits of omega-3, with or without proof of CVD prevention until Reduce-it completion. The FDA needs to answer to the American people why we cannot have access to such a safe and effective drug in a population with unmet need. After all, isn't that why we implemented Obamacare to promote comprehensive healthcare, insurance coverage for drugs and treatment, and most importantly, preventive care to reduce high medical costs.
    Dec 21, 2013. 02:29 PM | Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    I would not consider myself a scientist but as a clinician my education and knowledge came from the same source which taught me the benefits of omega-3 for heart health and its treatment/prevention but suddenly decided their hypothesis has been wrong? Have you read a heart-shaped label on a can of tuna? Is it wrong to continue to deceive the public with omega-3 benefits in foods such as milk, eggs, and fish while they consider it without benefits? I would not present complicated trial results to my patients but if our FDA has changed its view, I believe this requires a major public announcement which I believe will never happen. That's politics. The FDA is flip-flopping its position with reasons beyond my comprehension. There's no right or wrong at this point as Reduce-it hasn't been completed yet. But I have the obligation to my patients when I do not agree with our FDA's preference of "hard drugs" and citing irrelevant failed trials to discredit Vascepa benefits.
    Nov 24, 2013. 08:41 PM | Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    In my opinion, Amarin should consider the EMA and other countries but that's a question for the management as GIA was never their first choice. I believe different agencies operate under different guidelines, medical philosophy, public health measures, and political pressures (believe it or not). The EMA did not accept Qsymia and Belviq withdrew voluntarily but our FDA approved both. Due to cultural differences in diet and lifestyle, obesity, DMII, and heart disease are our nation's top public health concerns. It is why I believe the FDA decided these benefits outweighed risks in our existing culture, regardless of serious side effects. Similarly, the AHA expanded the indication for statin therapy by removing cholesterol benchmarks so we can approach treatment differently with the hope to keep it under control. However, it is counterproductive to double the target population by reenforcing statins alone when it did not prove to drastically reduce CVD morbidity or mortality as such disease progression is multi-factorial. It is my opinion that the FDA should give Vascepa equal consideration as an add-on therapy recommended by the AHA (2-4g omega-3 daily consumption in diet modification). I do not know anyone who can actually consume that much fish (risk of heavy metal contamination) or nuts everyday to benefit much from it, especially it is only EPA that makes the difference.
    Nov 24, 2013. 05:28 PM | 1 Like Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    Clinician Scientist, thank you for your analysis and a well-written article. I would just like to share that Vascepa is not a new concept. Epadel (used in JELIS) has been approved in Japan for many years to treat arteriosclerosis obliterates and hyperlipidemia under Cardiovascular Drug. It is deemed safe and effective. Recently, Epadel T is launched as an OTC version to treat "lifestyle related diseases" and indicated for “the treatment of triglyceride levels that are in the borderline region (150mg/dL to 300mg/dL), identified through health check-ups and other means.” Japan offers one of the world's best socialized medicine with a high standard of patient care. Their approved drugs are covered by the government, yet they still want to expand the use of EPA. We just took a major set-back by our FDA when they questioned the validity of EPA. It truly makes one wonder if we are really that far behind in medicine and science or what is the exact agenda behind FDA's decision to hold back Vascepa.
    Nov 21, 2013. 06:16 PM | 1 Like Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    It is irrelevant what you think of me as an Amarin shareholder. The opinion of my patients and their well-beings are what is important. If you'd even spent one day studying basic sciences, you would not be gloating and under-estimating omega-3 as the big pharmaceuticals would love to have you believe.
    Nov 19, 2013. 08:12 PM | 3 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    Mr. Adam F, I believe from what I've learned about you, you do not have a scientific background, public health understanding, or even any interest in Amarin other than your 50/50 prediction. CVD/CHD prevention and treatment are highly debatable already within the AHA/ACC community. Ultimately it comes down to how do we save lives given all the politics at play. If one out of three adults in America dies from heart disease and stroke, chances are it could be the person standing to your left, or your right, or yourself. If your doctor happened to prescribe statin to you, I'm curious to know if you'd be willing to take statin knowing all its long term side effects or would you be screaming for Vascepa at that point. Some of us are invested in Amarin because we believe in its potential and for a greater cause. It's not a drug that works 50/50 as you're desperately trying to destroy.
    http://bit.ly/17JOOcA
    Nov 19, 2013. 05:56 PM | 4 Likes Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    I hope you find these helpful as well. TG 200-499 mg/dL requires treatment (see Step 9) by NIH guideline. http://1.usa.gov/HPc1nC
    And also please look under Figure 9-2 Dyslipidemia where omega-3 therapy is listed in patients TG 200-499 mg/dL. http://1.usa.gov/HPc0jz
    Nov 10, 2013. 10:10 PM | Likes Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    Thank you sts66 for the clarification. The primary mission as a clinician is "do no harm" to patients. Just a reminder to our FDA. The American Heart Association clearly provided treatment guideline and recommendation to both clinicians and the public that lowering cholesterol and triglycerides are equally important in the prevention of CVD with supportive studies. Vascepa in my opinion, has the best safety profile in high triglyceride reduction. In essence, this factor alone makes it the drug of choice as it causes "the least harm" to patients as CVD is a chronic and progressive condition which requires not only intensive lifestyle and diet modifications but "prolonged exposure" to its treating drug.
    Nov 10, 2013. 10:16 AM | 1 Like Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    Thank you Steve for sharing your insights as always. As a healthcare practitioner, I'd like to share this page from the American Heart Association. Total cholesterol score is calculated by adding HDL + LDL + 20% triglyceride level. I cannot support our FDA's new position that lowering triglyceride does not help prevent CVD. http://bit.ly/1hnEdO2
    Nov 7, 2013. 05:31 PM | 1 Like Like |Link to Comment
  • AMRN: Does The FDA Need To Be Investigated  [View instapost]
    Thank you for your analysis. Insightful. As a healthcare provider, consumer, and an investor in Amarin (because I truly believe in their best-in-class product for a greater cause), I would like to add that if those panel experts have decided to change our conventional understanding of omega-3 benefits, the FDA perhaps should consider removing the heart logo on foods containing omega-3. The label reads, "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease..." In my opinion that is misleading to the general public. So which is it, FDA?
    Oct 22, 2013. 02:36 AM | 1 Like Like |Link to Comment
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