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Cytokinetics, Incorporated Message Board

dctrig 219 posts  |  Last Activity: 12 hours ago Member since: Jan 26, 2006
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  • Reply to

    Our ADCOM Panel Has Only 11 Members

    by dctrig Jun 5, 2014 3:50 PM
    dctrig dctrig Jun 5, 2014 3:54 PM Flag

    (Continued)
    Thomas H Inge, MD, PhD
    Expertise: Surgery; Pediatrics
    Term: 07/18/2013 - 12/31/2016
    Surgical Dir.; Comphrehensive Weight Management Center
    Cincinnati Children's Hospital Medical Center
    3333 Burnet Ave/MLC 2023
    Cincinnati, OH 45229-3039

    designated federal official
    Avena Russell, ABD, MS
    Center for Devices and Radiological Health
    Office of Device Evaluation
    10903 New Hampshire Ave.
    WO 66 Room #1535
    Silver Spring, MD 20993
    Phone: 301-796-3805
    Fax: 301-847-8122

  • Below roster was posted on FDA website 5/20/14, before Dr Woods was added.
    Chairperson
    Mark A. Talamini, M.D.2
    Expertise: General Surgery
    Term: 07/18/2013 - 12/31/2016
    Professor and Chairman, Dept. of Surgery
    Stony Brook Medicine Health Science Center
    T-19, Room 020
    Stony Brook, New York 11794-8191 Designated Federal Official
    Avena Russell, ABD, MS
    Center for Devices and Radiological Health
    Office of Device Evaluation
    10903 New Hampshire Ave.
    WO 66 Room #1535
    Silver Spring, MD 20993
    Phone: 301-796-3805
    Fax: 301-847-8122

    Sami R. Achem, M.D.3
    Expertise: Gastrointestinal Physiology
    Term: 01/01/2012 - 12/31/2015
    Professor of Medicine
    Mayo Clinic College of Medicine
    4500 San Pablo Road
    Jacksonville, FL 32224

    Abdelmonem A. Afifi, Ph.D.4
    Expertise: Biostatistics
    Term: 01/01/2012 - 12/31/2015
    Professor Emeritus, Biostatistics
    School of Public Health & Biomathematics
    Univ. of California, Los Angeles
    Box 951772
    Los Angeles, CA 90095

    **Craig F. Donatucci, M.D.5
    Expertise: Urology
    Term: 08/26/2013 – 12/31/2016
    Senior Medical Fellow
    Lilly Corporate Center
    1555 South Harding
    Indianapolis, IN 46285

    Ashley L. Faulx, M.D.6
    Expertise: Endoscopic Ultrasound
    Term: 07/18/2013 - 12/31/2016
    Associate Professor of Medicine
    Division of Gastroenterology & Liver Disease
    University Hospital Case Medical Center
    11100 Euclid Avenue
    Cleveland, OH 44106-5066

    *Mildred DuBois Fennal, MSN, Ph.D.7
    Expertise: Nursing Education
    Term: 01/01/2012 - 12/31/2015
    The International Nurse Education Consortium
    Street address not available
    Tallahassee, Florida 32311
    Susan J. Kalota, M.D.9
    Expertise: Urology
    Term: 01/01/2014 - 12/31/2017
    Urologic Associates of
    Southern Arizona
    6325 East. Tanque Verde Rd.
    Tucson, AZ 85715

    Susie Q. Lew, M.D., FACP10
    Expertise: Nephrology
    Term: 01/01/2014 - 12/31/2017
    Professor of Medicine and
    Director, Clinical Services
    George Washington University
    Medical Center
    2150 Pennsylvania Ave., NW, RM3-438
    Washington, DC 20037

  • Reply to

    3 Gastro-enterologists on ADCOM Panel a Positive

    by dctrig Jun 5, 2014 12:06 PM
    dctrig dctrig Jun 5, 2014 1:04 PM Flag

    Here is a sample ADCOM day:
    08:00 a.m. Call to Order
    Panel Introductions
    Conflict of Interest Statements
    08:15 a.m. Sponsor Presentation
    09:45 a.m. Q&A Sponsor
    10:00 a.m. Break
    10:15 a.m. FDA Presentation
    11:45 p.m. Q&A FDA
    12:00 p.m. Lunch
    01:00 p.m. Open Public Hearing
    02:00 p.m. Q&A Open Public Hearing
    02:15 p.m. Panel Deliberations
    03:30 p.m. Break
    03:45 p.m. FDA Questions
    05:30 p.m. FDA and Sponsor Summations
    05:40 p.m. Panel Vote
    06:00 p.m. Adjournment

  • Reply to

    3 Gastro-enterologists on ADCOM Panel a Positive

    by dctrig Jun 5, 2014 12:06 PM
    dctrig dctrig Jun 5, 2014 12:15 PM Flag

    6/5: On the front page of the business section of the Los Angeles Times is a huge article about the FBI raiding the Beverly Hills office of two brothers who ran a lap band mill that resulted in five deaths from 2009-2011. Dozens of FBI agents were involved and the FDA assigned a criminal agent to the case.
    Folks, this is why the FDA desperately wanted VBLOC to succeed.

  • They see patients with GI problems from lap band every day and should be expected to vote in favor of VBOC. I would love to know how many bariatric surgeons are on the panel; the ethical ones should vote for VBLOC as it lessens their lawsuit liability for lap band; in fact VBOC could actually boost or stabilize their income: Do VBOC first and after 1-2 years patient is unsatisfied, then remove implant and do gastici bypass or lap band.

  • It looks as though a mess of retail traders are being taken out. Setting stops is foolish on micro cap stocks that can be so easily manipulated.

  • Just as they did with the controversial painkiller Zohydro. The FDA is clearly VERY concerned about the obesity epidemic. Even if the FDA went against a negative ADCOM vote and approved VBLOC there would virtually be NO backlash.
    One may want to consider selling all or part of one's position, on a price spike, before ADCOM. If a negative vote eviscerates the stock price, one could buy back and profit from an FDA approval. Obviously there are many ways to play ETRM, a number of which could be profitable.

  • Reply to

    Wow whats the deal with this stock.

    by worldwide14u Jun 4, 2014 10:37 PM
    dctrig dctrig Jun 4, 2014 10:49 PM Flag

    VBLOC Maestro system is NOT A DRUG but a medical device. AF did talk to the company CFO last December after the 18-month data was released. His article is still on Yahoo and he's pretty much on the fence.
    I'm beginning to expect a divided ADCOM vote. The panel majority will probably vote that VBLOC is safe and will probably split about 50/50 as to whether VBLOC is effective enough to recommend approval. The July and August call options seem to expect quite a bit of volatility post 6/17 and awaiting the final FDA decision.

  • dctrig dctrig Jun 4, 2014 5:35 PM Flag

    The sharp downturn in the last three trading days is probably due to four factors: 1) Short selling 2) ATM stock issue/sale (3) Some big investors taking profits (4) overall market weakness.

  • POSITIVE net money flow into ETRM of $288,858 and 1.42 positive uptick ratio. A poster on Marketwatch pointed out that the waiver granted Dr Woods probably is related to the need to reschedule the 5/29 meeting to 6/17. It seemed the FDA worked very hard to achieve a balanced panel and needed at least three gastroenterologists.
    Congrats to those who dived in today. A rebound to around $2.50 before the end of next week is possible.

  • Reply to

    Bad Feeling...

    by rodtross Jun 3, 2014 11:56 AM
    dctrig dctrig Jun 4, 2014 12:33 PM Flag

    dmj3430: The ones who follow ETRM closely listen to ALL webcasts, not just press releases and SEC filings. The CEO did say in a webcast(no longer available) about a year ago that the FDA encouraged ETRM to file for VBLOC and told the company they could expect an ADCOM meeting.

  • Reply to

    Feel Sorry for Enteromedics...

    by tristano7177 Jun 3, 2014 3:33 PM
    dctrig dctrig Jun 3, 2014 4:13 PM Flag

    sugarman: I absolutely agree with your take. Even if the doctor votes for VBLOC it won't have much impact on her less than $50,000 investment in a competitor.

  • Reply to

    Feel Sorry for Enteromedics...

    by tristano7177 Jun 3, 2014 3:33 PM
    dctrig dctrig Jun 3, 2014 3:44 PM Flag

    While you're feeling sorry the smart money is still accumulating ETRM 15 minutes into the close: $215,822 POSITIVE NET MONEY FLOW.

  • (From the waiver dated May 21, 2014)
    Further, in the interest of public health, it is imperative that the committee has the expertise of Dr. Woods at this meeting and that the agency review new weight loss products and methods that could potentially change the manner in which this category of patients is treated. The steady increase in the population of those who battle obesity is of concern to this agency. A well-balanced discussion of these issues is necessary to ensure that products launched on the market are both safe and effective.

  • Reply to

    Bad Feeling...

    by rodtross Jun 3, 2014 11:56 AM
    dctrig dctrig Jun 3, 2014 12:22 PM Flag

    rodtross: Your ID says you have been on Yahoo since 1999! Surely you understand by now head fakes and accumulation, which Barrons shows still occurring today(6-3).
    THERE IS ONE BIG POSITIVE: The FDA encouraged ETRM to file and promised an ADCOM panel meeting. These meetings are expensive and not that common. WHAT IS MOST COMMON is that the FDA allows companies that missed a trial endpoint to go ahead and file into almost certain rejection.

    The FDA could have reviewed VBLOC without a panel meeting but did not. The FDA is panicked over the obesity epidemic and wants guidance from the panel.

  • dctrig dctrig Jun 2, 2014 11:54 PM Flag

    The big boys are already in as they own a majority of the outstanding shares and have for quite some time.

  • dctrig dctrig Jun 2, 2014 6:55 PM Flag

    Today, 6/2, on a down day designed to scare nervous nellies, Barrons showed ACCUMULATION in ETRM: 1.45 positive vs downtick ratio, and $461,546 POSITIVE net money flow into the stock.

  • dctrig dctrig Jun 2, 2014 3:44 PM Flag

    This is a great opportunity to buy sub $2 for the last time as Barrons still shows $332,000 POSITIVE net money flow today. This is a short bear raid as those who bought on margin at $2 or above are being pressured. Buy more if you can before the significant price rebound by Friday to about $2.50.

  • Reply to

    5000 June 2 1/2 calls traded at .47

    by innsbrooklad May 30, 2014 12:42 PM
    dctrig dctrig May 30, 2014 2:13 PM Flag

    Correction: Sanofi, not Lilly.

  • Reply to

    5000 June 2 1/2 calls traded at .47

    by innsbrooklad May 30, 2014 12:42 PM
    dctrig dctrig May 30, 2014 2:12 PM Flag

    The FDA appears to becoming more flexible in looking at additional data. Eli Lilly just got some encouragement from them.
    Sanofi ($SNY) has resubmitted Lemtrada, its long-in-development multiple sclerosis treatment, for FDA approval, gambling that a new analysis of the same data will sway regulators in a second review.
    The agency has accepted Sanofi's supplemental application, the company said, thus kicking off a 6-month review period with a final decision expected in the fourth quarter this year.
    In its rejection letter, handed down in December, the FDA contended Sanofi had not adequately demonstrated that Lemtrada's strengths outweighed its weaknesses, taking serious issue with the design of a Phase III study in patients with relapsing-remitting MS. And regulators made it clear that the once-a-year treatment wouldn't be approvable until Sanofi conducted one or more additional Phase III trials.
    But that's just not an option, Sanofi CEO Chris Viehbacher has said. After scrapping plans to appeal the FDA's decision, the company is instead supplementing its first application with fresh analysis, extended clinical results and "additional information to specifically address issues previously noted by the FDA," Sanofi said. The resubmission comes on the heels of "constructive discussions" with the agency, according to the company.

CYTK
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