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Insmed Incorporated Message Board

stu_har 78 posts  |  Last Activity: Aug 19, 2014 6:03 PM Member since: Feb 28, 2010
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  • Reply to

    The Lancet Artical, August 16, 2014

    by g550drvr Aug 16, 2014 7:48 AM
    stu_har stu_har Aug 19, 2014 6:03 PM Flag

    g550 & fargo,
    Thank you, this is all good for AMRN.

  • Reply to

    The Lancet Artical, August 16, 2014

    by g550drvr Aug 16, 2014 7:48 AM
    stu_har stu_har Aug 16, 2014 11:13 AM Flag

    g550,
    Nice find! Do you access to full article or just the summary? TIA.

  • Reply to

    Complex

    by frenzychess Aug 8, 2014 8:38 AM
    stu_har stu_har Aug 8, 2014 8:59 AM Flag

    "John Jenkins, M.D., Director, Office of New Drugs
    Dr. Jenkins joined FDA as a medical officer in the Division of Oncology and Pulmonary Drug Products in 1992. He subsequently served as Pulmonary Medical Group Leader and Acting Division Director before being appointed as Director of the newly created Division of Pulmonary Drug Products in 1995. Dr. Jenkins became the Director of the Office of Drug Evaluation II in 1999 and served in that position until he was appointed to his current position in January 2002.

    Dr. Jenkins received his undergraduate degree in biology from East Tennessee State University in 1979 and his medical degree from the University of Tennessee at Memphis in 1983. He completed his postgraduate medical training in internal medicine, pulmonary disease, and critical care medicine at Virginia Commonwealth University/Medical College of Virginia from 1983 until 1988.

    Dr. Jenkins is Board Certified in internal medicine and pulmonary diseases by the American Board of Internal Medicine. Following completion of his medical training, Dr. Jenkins joined the faculty of MCV as an Assistant Professor of Pulmonary and Critical Care Medicine and as a Staff Physician at the McGuire VA Medical Center in Richmond."

    Hopefully the egos are able to be set aside and the CDER/FDA does what it is tasked with:
    To perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. We shall find out, GLTA.

  • Reply to

    Jenkins will consult with CEDAR on AMRN appeal

    by spook2b Aug 7, 2014 5:01 PM
    stu_har stu_har Aug 7, 2014 5:08 PM Flag

    CDER - Center for Drug Evaluation and Research.

  • Reply to

    Scripts out and they blow

    by homebuilder_watcher Jan 17, 2014 9:32 AM
    stu_har stu_har Jan 17, 2014 10:30 AM Flag

    doc,
    Thanks. Is there a site where this info can be accessed? Otherwise, I will have to track based on homebuilders posted data. TIA.

  • Reply to

    Scripts out and they blow

    by homebuilder_watcher Jan 17, 2014 9:32 AM
    stu_har stu_har Jan 17, 2014 10:00 AM Flag

    typo - disappointing.

  • Reply to

    Scripts out and they blow

    by homebuilder_watcher Jan 17, 2014 9:32 AM
    stu_har stu_har Jan 17, 2014 9:56 AM Flag

    A bit dissapointing, but one week does not a trend make. Thank you Homebuilder.

  • Keep it going...up that is!

  • Reply to

    Question to the CP promoters

    by staccani Dec 27, 2013 1:21 PM
    stu_har stu_har Dec 30, 2013 11:28 AM Flag

    Please send me a copy at stu_har@ y a h o o...
    Thank you.

  • Reply to

    Rami Daoud is Stuart Sedlack's Replacement

    by koleminer1 Dec 30, 2013 12:59 AM
    stu_har stu_har Dec 30, 2013 10:39 AM Flag

    I read that first line (7 months...) to be with his former company, ACEA Biosciences.

  • Reply to

    Rami Daoud is Stuart Sedlack's Replacement

    by koleminer1 Dec 30, 2013 12:59 AM
    stu_har stu_har Dec 30, 2013 10:02 AM Flag

    From Linkedin:

    Summary
    Seasoned pharmaceutical professional with an extensive business development, strategy and financial experiences. Proven deal maker with an excellent reputation, extensive global BD network, exceptional financial and analytical skills, strong scientific background, good business acumen and a determination to drive deals & projects to successful conclusions.

    Specialties:Sourcing product or company partnership opportunities. Managing multi-functional due diligence assessments. Conducting market research and estimating commercial potential. Robust financial modeling and analyses to value projects and terms. Developing appropriate positioning and communication strategy. Structuring and negotiating deals. Developing corporate, product or therapeutic area strategies. Assisting early stage companies in business plan preparation, BD projects and financing.

    Experience
    Vice President, Business DevelopmentAmarin Corporation
    June 2013 – Present (7 months)Executive Director, Business DevelopmentACEA Biosciences
    July 2012 – June 2013 (1 year)|Greater San Diego Area
    Head of business development for ACEA Biosciences' Pharmacutical and Technologies business units.

    President and FounderRD Consulting, LLC
    2011 – 2012 (1 year)|Greater Philadelphia Area
    Transaction advisory firm providing business development, strategic and financial consulting support for pharmaceutical, biotech and medical device companies.

    Senior Director, Business DevelopmentAuxilium Pharmaceuticals
    2004 – 2011 (7 years)Manager, Business DevelopmentTransform Pharmaceuticals
    2003 – 2004 (1 year)Senior Associate, Corporate Business DevelopmentEli Lilly and Company
    2001 – 2003 (2 years)Senior Research Associate, Pre-Clinical R&DHuman Genome Sciences
    1996 – 2000 (4 years)|Washington D.C. Metro Area
    BiologistNational Institutes of Health
    1993 – 1995 (2 years)|Washington D.C. Metro Area

  • stu_har stu_har Dec 30, 2013 9:50 AM Flag

    Incredible! Talk about acting with impunity. It is sad that this orginazation is responsible to protect the public concerning food and drug safety.

  • Reply to

    Scripts week of 12/13

    by homebuilder_watcher Dec 20, 2013 9:59 AM
    stu_har stu_har Dec 21, 2013 4:26 PM Flag

    Thank you this information that you provide consistently. A question, should the NRx for Lovaza be "up", as the numbers are posted? Maybe they are transposed. TIA.

  • Reply to

    PDUFA Delayed!!!!

    by speedrunner199 Dec 20, 2013 6:41 AM
    stu_har stu_har Dec 20, 2013 9:40 AM Flag

    I second what akanz stated!
    Speed, Kole, et al
    Great work and thank you!

  • Reply to

    Comments on gov site

    by zippy1232002 Dec 19, 2013 10:51 AM
    stu_har stu_har Dec 19, 2013 11:12 AM Flag

    This is what is stated on the comment confirmation/receipt page:

    "Your comment will be viewable on Regulations.gov after the agency has reviewed it, which may be an indefinite amount of time. Use your tracking number to find out the status of your comment."

    Indefinite amount of time, our tax dollars hard at work!

  • Reply to

    Long Awaited Press Coverage

    by koleminer1 Dec 16, 2013 3:53 PM
    stu_har stu_har Dec 18, 2013 7:59 AM Flag

    On that basis, investors were betting that a big pharma that inks a deal with - or simply acquires – Amarin- would have a blockbuster on its hands, since the drugmaker hoped to steal market share from Lovaza, a $1 billion seller for GlaxoSmithKline (GSK). Zakrzewski, by the way, once marketed Lovaza for Reliant Pharmaceuticals, which was acquired by Glaxo.

    But the panel vote and FDA rescission, which Amarin appealed (see this), hammered the stock – prior to the panel meeting, Vascepa shares traded at about $7, and are now hovering below $2. The FDA is expected to issue a final decision on whether to allow broader use, although such an approval seems unlikely. Just the same, a group of investors has petitioned the FDA to change its mind and approve wider use.

    In the petition, they ask the agency to delay the December 20 approval date and conduct an independent scientific review of three outcome trials that were reviewed by FDA staffers, who maintained these raised “substantial scientific” issues and was used to justify the SPA, according to the petition. They also want the FDA to probe its staffers for possible misconduct.

    Why? They cite an implied failure of timely communication to Amarin about their concerns; improper processing of FDA briefing documents; omitting key data and information related to the outcomes trials cited by the FDA medical reviewer; an “improper and imbalanced review” of the studies; improper handling of the FDA panel and improper rescinding of the SPA (here is the petition).

    If this sounds like a last-ditch effort, well….

  • Reply to

    Time to Hear

    by korthh Dec 12, 2013 2:41 PM
    stu_har stu_har Dec 17, 2013 5:00 PM Flag

    H, I would like that. When I made the note about the encouragement part, I was mostly thinking of me and the opportunities I have missed to share the Gospel.

  • Reply to

    Time to Hear

    by korthh Dec 12, 2013 2:41 PM
    stu_har stu_har Dec 17, 2013 4:14 PM Flag

    Free will, what a concept! True that " It's up to them to believe or not", but it is up to us to sow the seed. Thank you for that. Also, the Bible states that this seed is "imperishable", and that should give us encouragement to sow that seed whenever possible.

  • Reply to

    Update on Citizen Petition

    by speedrunner199 Dec 17, 2013 1:35 PM
    stu_har stu_har Dec 17, 2013 1:47 PM Flag

    speed,
    Thank you that update, it is good to know.

  • Reply to

    Long Awaited Press Coverage

    by koleminer1 Dec 16, 2013 3:53 PM
    stu_har stu_har Dec 17, 2013 1:25 PM Flag

    bound,
    Use the link provided by kole in the originating post. Replace the * with the letter o

INSM
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