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  • USANA Health Sciences: This Dip Is Offering A Sweet Buying Opportunity [View article]
    @Rbbrooke- thanks
    @Mark Luo- Well your concern about illegal MLM pyramid scheme issue is valid but it is not going to harm USANA health sciences. We saw major dips in the shares of Nu Skin Enterprises Inc. following claims by People's Daily that the company was operating an illegal pyramid scheme in China. The Chinese government has recently begun an investigation on Nu Skin Enterprises, which has also affected the share price of several other companies with the same distribution model as investors fear that the investigation could extend to these direct selling companies as well. However, this won't hamper any meaningful long-run concerns for investors of USANA. because--

    Nu Skin earns half of its revenue from China, USANA earns around 60% of its revenue from China. Still, USANA hasn't observed the skyrocketing growth in China that Nu Skin has lately, which shows-- there are very less chances that USANA too will catch the ire of the NU Skin. I don't see that current MLM pyramid scheme issue will harm investors' sentiments in long-run for USANA..

    Hope it helps!
    Jan 21, 2014. 01:28 AM | 1 Like Like |Link to Comment
  • InterMune: Esbriet And Ascend Will Drive Growth [View article]
    @Jacosa- I sincerely apologize for misspelling of your name in the previous comment.
    Dec 24, 2013. 12:39 AM | Likes Like |Link to Comment
  • InterMune: Esbriet And Ascend Will Drive Growth [View article]
    @ jasoca--Thanks for your feedback
    Dec 21, 2013. 01:08 PM | Likes Like |Link to Comment
  • Why Genomic Health Is A Solid Long-Term Buy [View article]
    @P Salerno- At present reimbursement is available for breast cancer only and for colon cancer, it is in progress.
    Regarding the prostate test-- Prolaris is the only test available in the market that demonstrates predictive value in both pre and post prostatectomy conditions. It is approved by the FDA for use in low-risk men with a Gleason score of 6, as well as for post-prostatectomy patients who are categorized in the high-risk zone for prostate cancer recurrence.
    On the other hand, The Oncotype DX prostate cancer test measures the level of expression of multiple genes across multiple pathways that predict aggressive prostate cancer, overcoming issues related to tumor heterogeneity, biopsy under-sampling and under-staging to substantially improve individualized risk assessment at diagnosis, prior to treatment intervention. In short it predicts the recurrence of prostate cancer in pre-prostatectomy conditions.
    http://bit.ly/IP7Jfx

    Hope it helps.
    Dec 11, 2013. 06:05 AM | Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    I would say again, Vascepa which is a form of EPA, should produce positive results, considering JELIS study results. JELIS study was done in 2007 in order to identify effectiveness of EPAs. In JELIS trail EPA dose was 1.8 gm, and in REDUCE-IT Vascepa dose is 4 gm.

    The patients who were enrolled in the JELIS study had a higher baseline level of omega-3 fatty acids than the patients in REDUCE-IT. I believe that with the Vascepa 4gm per day dose, the company may receive positive results upon the completion of the REDUCE-IT study as well.
    Dec 2, 2013. 02:33 PM | Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    Ethyl eicosapentaenoic acid (E-EPA) marketed as Vascepa, Epadel, EPAX, is a synthetic derivative of the omega-3 fatty acid eicosapentaenoic acid (EPA). In Japan, E-EPA is often called EPA-E.
    Dec 2, 2013. 01:52 PM | Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    Please read this: http://bit.ly/N3oscx

    and the hyperlink I shared in the article: http://bit.ly/IBm8fy
    Dec 2, 2013. 01:51 PM | Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    JELIS study tested the effects of long-term use of E-EPA (1800 mg/day) in addition to a statin in Japanese patients with hypercholesterolemia. In this study, AstraZeneca Epanova has showed superior efficacy compared to both Lovaza and Vascepa. As mentioned in my article.
    Dec 2, 2013. 11:39 AM | Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    I never said anywhere in my article that the Reduce-IT study has been scraped. My point was: The REDUCE-IT study still is ongoing, which will be evaluating Vascepa's safety and efficacy in reducing the cardiovascular events, or CVEs among the high level TG patients who are taking statins.
    Dec 2, 2013. 11:12 AM | Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    In the notice dated Oct 29, 2013, the FDA, with support of examples like ACCORD-Lipid, AIM-HIGH, and HPS2-THRIVE, inferred that these studies fail to support the hypothesis that a TG-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum TG levels.”

    http://on.wsj.com/1aqjEXJ
    Dec 2, 2013. 11:08 AM | 1 Like Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    http://bit.ly/1baQW0s


    Consistent with the discussion at the October 16, 2013, Endocrinologic and Metabolic Drugs Advisory Committee (the “Advisory Committee”)
    meeting at which the Advisory Committee voted to recommend against approval of the proposed label expansion for Vascepa® (icosapent
    ethyl) capsules under the pending supplemental New Drug Application (the “sNDA”) that seeks to expand Vascepa labeling to include the
    proposed ANCHOR indication, on October 29, 2013, Amarin Corporation plc (“Amarin”) received written notification from the U.S. Food and
    Drug Administration (the “FDA”) that the FDA has rescinded the ANCHOR study special protocol assessment agreement because the FDA has
    determined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after
    testing began. Specifically, consistent with discussion at the Advisory Committee meeting, the FDA cited results from the ACCORD-Lipid and
    AIM-HIGH outcome trials, as well as the publicly presented results from the HPS2-THRIVE outcome trial, which the FDA stated in its
    October 29, 2013 notice to Amarin, fail to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for
    cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum triglyceride levels (200-499 mg/dL).
    Thus, the FDA stated that it no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug
    intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL.
    Dec 2, 2013. 11:07 AM | Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    The company hasn't disclosed about any partnership to fund its ongoing study. As in this article, I had mentioned about the cost reduction strategy, in which it has reduced the half of its workforce and the cost saved from this restructuring may be used by the company to continue its funding to run the study.
    Dec 2, 2013. 10:39 AM | Likes Like |Link to Comment
  • Any Hopes Left For Amarin Bulls? [View article]
    It is expected, if Amarin is able to receive the Complete response letter, CRL from the FDA, then the company based on the recommendation in the CRL will work on removing the deficiencies associated with Vascepa. This will results in improving the efficacy of Vascepa in treating TG patients.
    Dec 2, 2013. 10:36 AM | Likes Like |Link to Comment
  • Zerenex- The New Spark For Keryx? [View article]
    In this article, I had focused on CKD and both the companies are developing their drugs to treat stage 3 and stage 4 CKD patients. Once Rayaldy receive the approval from the regulatory body, then it will be used to treat patients suffering with moderate CKD in the U.S. and elsewhere, with SHPT and Vitamin D deficiency. This is the reason for labeling Rayaldy as the competitor to Zerenex only for the treatment of CKD, not for NDD-CKD.

    Definitely, Zerenex is able to reduce the use of expensive IV iron and ESAs, and may be approved as anemia drug. However, my focus is on CKD, and looking at Rayaldy's ability to treat moderate CKD, and SHPT patients, it will able to reduce the further chances of renal disease and hence my point to label Rayaldy with Zerenex.
    Nov 27, 2013. 04:17 AM | Likes Like |Link to Comment
  • Zerenex- The New Spark For Keryx? [View article]

    @mswyman There are no plans disclosed by the companies for developing combinational therapy of Rayaldy and Zerenex. Both these companies are developing their drugs to enhance their own revenue and focusing on developing their drug portfolio stronger.

    Contrary, if both the drugs are used as the combination then they may pose high efficacy, and the combination will be all-in-one drug to treat CKD, NDD-CKD, SHPT, Iron deficiency, and Vitamin D deficiency in my view.
    Nov 26, 2013. 09:23 AM | 1 Like Like |Link to Comment
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