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Zumiez, Inc. Message Board

theguywho2 5 posts  |  Last Activity: Oct 20, 2014 10:37 AM Member since: Mar 23, 2005
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  • The interim analysis was performed on data from the first 50% of patients
    who completed the study. The purpose of the interim analysis was to allow for a
    sample size adjustment if necessary to maintain appropriate statistical power to
    detect a treatment effect between Clonidine Topical Gel and placebo.
    BDSI views the outcome of the analysis as very encouraging. As a result
    of the interim analysis, a total of approximately 80 additional patients will be
    added to the ongoing trial in an effort to maintain 90% percent power to detect
    a statistically significant difference between Clonidine Topical Gel and placebo.
    The analysis was executed by an independent biostatistician.
    "We are encouraged by the outcome of the interim analysis," stated Dr. Andrew
    Finn, Executive Vice President of Product Development at BDSI. "The additional patients
    not only allow us to maintain the probability of ultimately meeting the study's
    endpoints, but given that the initial study enrollment was about three months ahead
    of schedule, we still anticipate having top-line results by the end of the first
    quarter of 2015. In addition, the expanded sample size will provide an adequate
    number of subjects to complete the required long-term safety study that will be
    part of our NDA package. Also part of the NDA will be a second pivotal trial that
    we anticipate starting in early 2015."
    "The outcome of the interim analysis is significant because it utilized actual
    study data to make a sample size adjustment to maintain the probability of a successful
    outcome," said Dr. Mark A. Sirgo, President and Chief Executive Officer. "Based
    on this information we will continue to progress other aspects of the clinical development
    program necessary for the NDA."

  • theguywho2 by theguywho2 Sep 5, 2014 11:32 AM Flag

    Keryx Biopharmaceuticals Receives FDA Approval of Ferric Citrate, a New, Oral Iron-Based Treatment for Dialysis Patients With Hyperphosphatemia
    Fri Sep 05 11:18:12 2014 EDT
    NEW YORK, Sep 05, 2014 (GLOBE NEWSWIRE via COMTEX News Network) --

    Ferric Citrate: Highly Effective at Controlling Serum Phosphorus Levels, With
    Unique Pharmacodynamic Properties
    Conference Call Scheduled for Noon Today
    Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the "Company") today announced
    that the U.S. Food and Drug Administration (FDA) approved Ferric Citrate (formerly
    known as Zerenex) for the control of serum phosphorus levels in patients with chronic
    kidney disease (CKD) on dialysis.

  • theguywho2 by theguywho2 Sep 9, 2014 1:37 PM Flag

    Applied Optoelectronics Reports Fifth Consecutive Quarter of Record Revenue

    Second Quarter 2014 Highlights
    -- Record revenue of $32.7 million grew 67% year-over-year and 31%
    sequentially

    -- Data center revenue grew 170% year-over-year and 55% sequentially to
    reach a new record of $17.9 million

    -- CATV revenue of $10.6 million increased 1% year-over-year and 9%
    sequentially

    -- Record fiber-to-the-home revenue of $3.1 million grew 339% year-over-year
    and 40% sequentially

  • theguywho2 theguywho2 Sep 11, 2014 9:44 AM Flag

    Go Roth !

  • SUNNYVALE, Calif., Oct. 20, 2014 (GLOBE NEWSWIRE) -- Alliance Fiber Optic Products, Inc. (AFOP), an innovative supplier of fiber optic components, subsystems, and integrated modules for the optical network equipment market, today announced that it ranked 40th in Forbes' annual list of "America's Best 100 Small Companies". AFOP has appeared on Forbes list four times since 2010. Forbes named AFOP one of the "Most Trustworthy Companies" in 2010, and one of the "America's Best 100 Small Companies "in 2012 and 2013.

    The Forbes "America's Best 100 Small Companies" list selected the top 100 publicly traded companies with sales under $1 billion, based on earnings growth, sales growth and return on equity in the past 12 months and over five years. Forbes' methodology also factors in each company's stock performance versus its peer group during the past 12 months. The full list can be found athttp://www.forbes.com/best-small-companies/list/.

    "What a great accomplishment for AFOP to make the list again this year," commented Peter Chang, President and CEO of AFOP. "It is a particular honor to be in such good company with other distinguished organizations also selected in 2014."

    Forbes commented, "Small caps present tremendous opportunities for investors with faster growth potential in many cases versus multi-billion dollar conglomerates. Each year Forbes looks to identify up-and-coming companies that have displayed strong, consistent growth in our feature on America's Best Small Companies."

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