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Amarin Corporation plc Message Board

marsala1234 13 posts  |  Last Activity: Dec 10, 2014 3:33 PM Member since: Jan 31, 2003
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  • marsala1234 marsala1234 Sep 26, 2014 1:25 PM Flag

    I heard the Osgood file on the way into work today. It was basically a redo of the AOL video spot with the same 2 doctors talking. What amazed me was that Charles sounded like a walking advertisement for Exact. It was almost like he was being paid to run the spot. (that couldn't possibly happen :) )

  • Reply to

    Affordable Care Act will be our friend in 2015

    by ranjovance Oct 14, 2014 8:53 PM
    marsala1234 marsala1234 Oct 14, 2014 11:59 PM Flag

    Ranjo - where did you get information that the USPSTF review of CRC will be in early/mid 2015? I thought KC said it would be end of 2015? Thanks

  • Reply to

    AMAZING conference call… EXAS is a winner!

    by sleepyeye55 Oct 27, 2014 10:55 AM
    marsala1234 marsala1234 Oct 27, 2014 2:41 PM Flag

    Yeah lots of good stuff Ranjo. I was surprised by the # of orders already. 1000 between fda approval and CMS decision and 1150 since. I know orders don't necessarily = revenue but that would be $1 million in orders already and they are accelerating - very nice.

  • Abstract and Introduction
    P G Vaughan-Shaw, M Aung, K Sahnan, P Rai, A Goodman
    Disclosures
    Frontline Gastroenterol. 2014;5(4):249-253.

    Abstract

    Objective An important marker of colonoscopy quality is detection of pathology and incidence of missed pathology. Back-to-back colonoscopies cannot ethically be performed for quality assurance alone yet may be required for clinical reasons. This study aims to investigate the incidence of new findings in colonoscopies repeated within a 12 month period and considers the role of such an analysis in the assessment of colonoscopy quality.

    Design All colonoscopies performed over a 3-year period at an endoscopy training unit were studied. Colonoscopies repeated within a 12-month period were analysed.

    Results 5747 colonoscopies were performed over the study period. 137 repeat colonoscopies were included with median interval from initial colonoscopy of 174 days. 19 (14%) repeat colonoscopies yielded new findings including one cancer, 234 days following a normal colonoscopy. Additional polyps were identified in 13 colonoscopies indicating a missed polyp rate of 9%. In these, a median number of two polyps per colonoscopy with median size 5.5 mm were found. There was no morbidity associated with repeat colonoscopy in this series. New findings on repeat colonoscopy appeared more likely following initial colonoscopy by non-consultant non-training grade endoscopists (23% vs 11%, p=0.09) yet small numbers involved preclude meaningful comparison.

    Conclusions Analysis of clinically indicated repeat colonoscopies and rate of detection of new pathology may offer utility in colonoscopy quality assurance and would offer a direct assessment of the most important aspect of colonoscopy quality.

    Funny- 14% is about the false +'s of Cologuard!

  • marsala1234 by marsala1234 Nov 27, 2014 11:51 PM Flag

    High Price Tag for Cologuard Confirmed, but Test Is Welcomed

    Zosia Chustecka
    November 26, 2014

    A final price decision has been announced for Cologuard (Exact Sciences), the first stool DNA colorectal cancer (CRC) screening test, which was approved in the United States earlier this year.

    The Centers for Medicare & Medicaid Services (CMS) has issued its final payment decision regarding Cologuard and will reimburse it at $502 per test, the company announced.

    The final payment decision follows a comprehensive evaluation by the agency as part of a joint FDA and CMS parallel review pilot program, the company said, and noted that Cologuard is the first technology to gain approval through this program.

    The price is hugely more than that of traditional stool tests for CRC screening, which home in on hemaglobin in blood in the stool samples. There are various such tests available, with the simpler fecal occult blood test (FOBT) costing around $4 per test and the more sophisticated fecal immunochemical test (FIT) costing around $8 per test, according to a 2012 article. The same article gives an average cost for colonoscopy, which is considered to be the best method for CRC screening, at $ 6345 per procedure.

    Improvement on Traditional Tests?

    When it was approved, the FDA pointed out that Cologuard detected more cancers than the commonly used FIT.

    The clinical data come from a pivotal trial that compared the two tests in nearly 10,000 individuals (N Engl J Med. 2014;370:1287-1297. Abstract). Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas; by contrast, FIT screening detected 74% of cancers and 24% of advanced adenomas.

    However, Cologuard was less accurate than FIT at identifying patients who tested negative for colorectal cancer or advanced adenomas, giving a negative screening result for 87% of the cohort vs 95% for FIT.

    (cont)

  • Reply to

    Medscape article

    by marsala1234 Nov 27, 2014 11:51 PM
    marsala1234 marsala1234 Nov 27, 2014 11:52 PM Flag

    The new test was welcomed by experts when it was approved, even though they warned that it would be more expensive than traditional stool tests.

    The new test does more: "We are looking for DNA changes, methylation changes, and fecal blood, all in one test," commented John Marshall, MD, professor of medicine and director of clinical research at the Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, in his Medscape Oncology videoblog.

    It performed better than FIT in terms of detection, but it was slightly less accurate, he noted. "This means that we will see a few more false positives with this test, but nonetheless, it is a useful test."

    "I believe the role ― the niche ― for this technology will be in that group of patients who refuse colonoscopy or cannot have colonoscopy. There probably will be some crossover with colonoscopy, and this test will be used along with that. Regardless, whatever it takes to get people to undergo screening to keep them out of my office is valuable," he said.

    "It is a test that should be offered to patients who refuse colonoscopy," agreed another expert, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, in Norfolk, in a Medscape Gasteroenterology videoblog. He also warned that the test will be expensive, but argued that "it is money well spent if it brings the people who refuse colonoscopy into a screening program." He added, however, that "cost analysis and cost-effectiveness remain to be defined."

    But Dr Johnson was adamant that "no screening is not an option. Any screening is better than nothing. We have a screening gap of approximately 20%; we are going to need to increase screening rates from 60% to 80% by 2018."

    (cont)

  • Reply to

    Medscape article

    by marsala1234 Nov 27, 2014 11:51 PM
    marsala1234 marsala1234 Nov 27, 2014 11:52 PM Flag

    He was hopeful that the new test "will stimulate discussions between patients and their healthcare providers. Colonoscopy is still the preferred strategy, but for anything that raises the awareness of screening and acceptability of screening, I am all in."

  • Reply to

    United Healthcare a bunch of sleazeballs

    by biotecher86 Dec 1, 2014 11:04 AM
    marsala1234 marsala1234 Dec 1, 2014 12:21 PM Flag

    UHG basically intentionally reviewed Cologuard before Final CMS determination, did not include DEEP C data or NEJM article, cherry picked the USPSTF old guidelines and ignored the new ACS approval of Cologuard so they don't have to pay for it (except their Mcare members) and can bargain on price.
    Typical UHG move.

  • marsala1234 by marsala1234 Dec 2, 2014 3:24 PM Flag

    Boston-based Heng Ren Investments LP, which describes itself as a friendly activist investor in Chinese stocks, is urging Sinovac Biotech (NASDAQ: SVA) to boost its disclosure and IR efforts. In a letter sent to Sinovac's Chairman and Chief Executive Officer, Mr. Weidong Yin, Heng Ren's Managing Partner and Portfolio Manager, Peter Halesworth, highlighted four ways the company could increase shareholder value:

    1. Timely Disclosure on Regulatory Status of Vaccine EV71 - During Sinovac’s Third Quarter 2014 conference call on November 17, Chairman Yin said in the coming weeks he did not plan to disclose to shareholders the outcome of a key step – an expert panel review - in the China Food and Drug Administration’s (CFDA) advanced review of Sinovac’s new vaccine, EV71(Enterovirus 71). Heng Ren stated itsdisagreement with Sinovac’s plan not to disclose the upcoming outcome. "We believe this is a material event for Sinovac and its shareholders.Sinovac has invested heavily in the research and development of the EV71 vaccine," Heng Ren said.

    2) Hire Specialist Health Care Investor Relations Firm - Heng Ren notes health care investors in the United States are highly technical and demanding of public companies for scientific, medical, and financial information. They note there are Investor Relations firms that specialize in representing health care companies, especially those like Sinovac with important early-stage products.

    3) Intensify Attendance at Investment Conferences - Heng Ren's research found more than 30 investment conferences scheduled between November 23, 2014 and March 31, 2015 available for health care companies like Sinovac to present to both generalist and health care investors. According to Sinovac’s Investor Relations calendar of events, its management so far has no plans during this period to attend any conferences, nor has it attended any investment conferences for more than two months. (cont)

  • Reply to

    activist investor

    by marsala1234 Dec 2, 2014 3:24 PM
    marsala1234 marsala1234 Dec 2, 2014 3:24 PM Flag

    (cont)
    Heng Ren believes more outreach is needed to increase Sinovac’s visibility with investors. Heng Ren offered to assist Sinovac by supplying a list of these upcoming conferences,

    4) Intensify International Expansion - Sinovac has achieved international recognition. Sinovac is collaborating with the World Health Organization (WHO) to develop and commercialize polio vaccine. As mentioned, a peer-reviewed publication of Sinovac’s EV71 Phase III clinical trials was published in The New England Journal of Medicine. As shareholders, we applaud Sinovac’s development of business and sales in Mexico, Mongolia, Nepal, and The Philippines. Heng Ren recommends Sinovac extend its sights to sell its vaccines in the United States, where hepatitis and influenza vaccines like Sinovac’ssell at a significant premium to prices in China. Heng Ren offered to assist Sinovac in this search for a distribution partner in the United States.

    "We believe it is important at this time for Sinovac to intensify investor relations, disclose material events in a timely fashion, and maximize opportunities for shareholder returns," said Halesworth. "We recommend these become top priorities for senior management at Sinovac."

    Chairman Yin thanked Heng Ren for the feedback and support. Mr. Yin stated that Sinovac, based in Beijing, China, would consider Heng Ren’s recommendations.

  • Reply to

    It's time...

    by xzw7yx_2000 Dec 9, 2014 9:38 AM
    marsala1234 marsala1234 Dec 9, 2014 11:21 AM Flag

    Ranjo- we thought we knew Amarins final destination too :). Nothing wrong with re-balancing the portfolio a bit after a big run, while keeping a good core position. Boy - does exas look strong though.

  • Reply to

    It's time...

    by xzw7yx_2000 Dec 9, 2014 9:38 AM
    marsala1234 marsala1234 Dec 9, 2014 11:42 AM Flag

    Kleeno - believe me I'm enjoying the ride. Been here since 2006. I'm just saying never say never and sometimes taking a bit off the table to diversify an out of whack portfolio allows you the strength to stay in for the long hall. Everyone has a different mentality for risk.

  • New article in Medscape includes Cologuard in top 10 for 2014 - nothing new but good promo.

    Multitarget Stool DNA Testing for Colorectal-Cancer Screening

    Imperiale TF, Ransohoff DF, Itzkowitz SH, et al

    N Engl J Med. 2014;370:1287-1297

    How Do Stool Screening Tests Compare?



    The latest iteration of fecal DNA testing is a combination assay that includes molecular tests for KRAS mutations, aberrant NDRG4 and BMP3 methylation, beta-actin, and an immunoassay for hemoglobin by fecal immunochemical testing (FIT). This study compared the performance of this new assay with FIT in detecting CRC in patients undergoing screening colonoscopy.

    The sensitivity of the fecal DNA assay was 92.3% for CRC overall (as well as consistent across stages I-III), compared with 73.8% for FIT. Moreover, the sensitivities were 69.2% for high-grade dysplasia and 42.4% for sessile serrated polyps (≥ 1cm), compared with 46.2% and 5.1%, respectively, for FIT.

    Clearly, this assay is an effective alternative technology for CRC screening. Whether this will achieve screening in patients who otherwise resist colonoscopy remains to be seen. Furthermore, the cost-effectiveness of detection and prevention of CRC death remains uncertain.

AMRN
1.13+0.08(+7.62%)Dec 19 4:00 PMEST

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