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Cytokinetics, Incorporated Message Board

dctrig 217 posts  |  Last Activity: Jul 18, 2014 3:20 PM Member since: Jan 26, 2006
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  • Reply to

    Anyone Follow Adam Feuerstein on Twitter?

    by dctrig Jun 10, 2014 9:45 AM
    dctrig dctrig Jun 10, 2014 9:50 AM Flag

    It appears that Alan will be attending the meeting on 6/17; he has blogged in real time in the past on panel discussions.

  • Two of his recent posts on Marketwatch:

    "Any interest in a $ETRM FDA panel live blog?"
    "Funniest factoid about $ETRM If you implant a sham device, never turn it on, patients lose more weight in 1 yr than on $ARNA Belviq. "

  • Reply to

    GAMES, MORE GAMES, MORE MORE GAMES....

    by adeiflig Jun 9, 2014 2:52 PM
    dctrig dctrig Jun 9, 2014 4:14 PM Flag

    A huge buyout premium like IDIX tends to foster M & A speculative fever throughout the drug and medical device market. FYI, I did sell 3000 shares today:
    "Your Day sell order for 3000 ETRM at a limit price of $1.84 was executed at $1.841. See order # 717 for details."

  • Reply to

    GAMES, MORE GAMES, MORE MORE GAMES....

    by adeiflig Jun 9, 2014 2:52 PM
    dctrig dctrig Jun 9, 2014 3:20 PM Flag

    Adeiflig: I am selling 3000 shares each day from today to Thursday, and maybe Friday, only holding a small position going into Monday, UNLESS there is a major price move up. The Market can and has been wrong, but the lack of movement today in ETRM after Merck's astounding buyout of Idenix gives me pause.

  • Reply to

    will Merck get away with it?

    by jupiter_symphony33 Jun 9, 2014 1:15 PM
    dctrig dctrig Jun 9, 2014 2:51 PM Flag

    goldmato: You said clearly what every savvy investor practices. I foolishly let a $75,000 paper profit collapse to an actual $48,000 loss on Encysive(ENCY) back in 2007-08.

  • Reply to

    will Merck get away with it?

    by jupiter_symphony33 Jun 9, 2014 1:15 PM
    dctrig dctrig Jun 9, 2014 2:49 PM Flag

    value_investor: Another dreamer who talks about "potential". California Chrome had "potential" to win the Triple Crown and didn't. Take your windfall and shut up.

  • Reply to

    will Merck get away with it?

    by jupiter_symphony33 Jun 9, 2014 1:15 PM
    dctrig dctrig Jun 9, 2014 2:47 PM Flag

    Jupiter: Are you an ambulance chaser? MRK made instant millionaires out of many retail owners. Quit your whining and take your profits...ingrate!

  • Reply to

    Placebo effect (reviewed)

    by adeiflig Jun 7, 2014 3:33 PM
    dctrig dctrig Jun 8, 2014 3:36 PM Flag

    tristano: I am also leaning toward a mixed panel vote, but an FDA approval; as you said, if this happens there will be much money to be made on the stock price crash and then explosion after FDA approval. Hyper optimists ignore that the panel WILL NOT consider the moderate effect on hypertension and diabetes, as all weight loss regimens do the same thing. The panel will vote that VBLOC is safe but will be very mixed, perhaps negative, on its efficacy.

  • Reply to

    REVENUE FORCAST FROM VBLOC...

    by adeiflig Jun 6, 2014 9:41 AM
    dctrig dctrig Jun 6, 2014 3:48 PM Flag

    Ade: The first six months is just educating doctors-don't forget that VBLOC won't get major insurance/Medicaid/medicare coverage for about a year after approval. Australia is a prime example, very little insurance coverage so far.

  • Reply to

    REVENUE FORCAST FROM VBLOC...

    by adeiflig Jun 6, 2014 9:41 AM
    dctrig dctrig Jun 6, 2014 3:02 PM Flag

    My forecast: 1000 patients at $10,000 = $10 million 1st FULL year

  • Reply to

    Ethics of Sham Control Group In VBLOC Trials

    by dctrig Jun 5, 2014 10:52 PM
    dctrig dctrig Jun 5, 2014 11:29 PM Flag

    Whiterain101: Thanks for the thoughtful response. I'm beginning to lean towards a belief that the panel vote will be equivocal, but that the FDA will approve VBLOC within certain guidelines. Rationale: The panel will only have a few days to review the FDA briefing documents and one day to hear arguments and then vote; on the other hand, the FDA has interacted with Enteromedics on VBLOC for a few years and has a much deeper understanding of the mechanism.
    I wonder if the panel will have access to the Australian and EMEA dossiers on VBLOC. The FDA obviously does as they have written agreements with a number of ex-USA FDAs to share their data.

  • I think I read somewhere that the FDA would not in the future condone the sham implanting of a device and their leads in a non-short term life threatening disease such as obesity. VBLOC could have just as easily been compared against existing weight loss therapies.

    Enteromedics' Lea argues that the control arm from the study should be disregarded because patients were surgically implanted with an inactive device. These are not real "placebo" patients, he says, so it's more meaningful to look at the weight loss derived from active VBLOC Therapy on its own. (I hope that the presenter for VBLOC at the 6/17 meeting will hammer this point home and ask the panel to take the sham patient results with skepticism).

    A year's worth of VBLOC Therapy resulted in an average 9% weight loss, which is equivalent to the weight loss patients get with a year's worth of Vivus' (VVUS_) Qsymia.

  • Reply to

    Won't be a run-up pre-ADCOM

    by crew_run Jun 5, 2014 3:52 PM
    dctrig dctrig Jun 5, 2014 4:27 PM Flag

    We should finish in the green tomorrow, Friday. On another down day Barrons still showed ACCUMULATION of $208,601 and 1,21 uptick ratio.

  • 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.

CYTK
4.24-0.01(-0.24%)Jul 25 4:00 PMEDT

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