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Theravance Inc. Message Board

equityvaluation 38 posts  |  Last Activity: Jul 2, 2014 2:23 PM Member since: Sep 12, 2005
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  • Form 4 AVEO PHARMACEUTICALS For: Jul 01 Filed by: EVNIN ANTHONY B

    Sentiment: Buy

  • According to the SEC filing released after the close, AUXL director CLASSON ROLF A purchased shares at a price of $20.06 on 6/30/14

    Sentiment: Buy

  • The DME indication is perhaps the most significant one that Eylea has been approved for and should be a huge revenue driver for REGN.

    Sentiment: Buy

  • The firm thinks that Regeneron has a number of upcoming potential major positive catalysts and recommends buying the stock on any pullbacks. It keeps a $349 price target and Outperform rating on the shares.

    Sentiment: Buy

  • Stocks To Watch For June 20, 2014
    António Costa, Benzinga Contributor
    June 20, 2014 7:43 AM

    EnteroMedics Inc (NASDAQ: ETRM) Volume starts to pick up again. It could make a huge move to the upside. Keep ETRM on your watch list. A break of $1.83 with force might give the stock room to $2.17.

    Sentiment: Buy

  • Reply to

    FDA's summary of yesterday's adcom part 1

    by equityvaluation Jun 18, 2014 5:52 PM
    equityvaluation equityvaluation Jun 18, 2014 5:58 PM Flag

    The FDA's website has the minutes listed under 24 hour summary in the Recently Updated Advisory Committee Materials

    Sentiment: Buy

  • Summary of the
    Gastroenterology and Urolog
    y Devices Panel Meeting
    June 17, 2014
    Introduction:
    The Gastroenterology and Urology Devices Panel
    of the Medical Devices Advisory Committee
    to the Food and Drug Administration met on June
    17, 2014 to discuss, make recommendations,
    and vote on information related to the pr
    emarket application (PMA) for the Maestro
    Rechargeable System sponsored by Enteromedics
    , Inc. The Maestro Rechargeable System
    provides
    Vagal Blocking Therapy for the Treatment of Obesity
    (VBLOC). The implantable device
    is a neuromodulator, which delive
    rs high frequency (5000 Hz), cont
    rollable electri
    cal pulses to
    the intra-abdominal vagus nerve trunks. The eff
    ect of VBLOC therapy is
    reported to suppress
    neural signals carried by the vagus nerve tr
    unks, resulting in decreased hunger pangs, and
    increased satiety. The device cons
    ists of implantable electronic
    device components that deliver
    VBLOC therapy to the abdominal vagus nerve trunks
    , and external components used to recharge
    the device and set therapy parameters.
    The proposed Indication for Use for the Maestro Rech
    argeable System, as stated in the PMA, is
    as follows:

    The MAESTRO Rechargeable System is indica
    ted for use in weight reduction in adult
    patients with obesity who have a Body Mass Index (BMI) of at least 40 kg/m
    2
    , or a
    BMI of at least 35 kg/m
    2
    with one or more obesity related co-morbid conditions, and
    have failed at least one supervised weight
    management program within the past five
    years.
    Open Public Hearing:
    There were 13 speakers during the open public hear
    ing portion of the panel meeting. In general,
    most supported the use of this device.

    Sentiment: Buy

  • June 18 (Reuters) - EnteroMedics Inc's shares jumped about 37 percent in premarket trading on Wednesday, a day after an advisory panel to the U.S. Food and Drug Administration voted in favor of the company's device to treat obesity.

    The independent panel voted 8 to 1 in favor of the device's safety and 6 to 2, with one abstention, that the device's benefits outweighed its risks.

    "The panel reaffirmed our thesis that (the device) offers a less invasive and safer, yet effective, treatment for the large and under-treated obese population," Roth Capital Partners analyst Chris Lewis wrote in a note.

    The pacemaker-like device, called Maestro Rechargeable System, blocks certain nerves that regulate digestion and stomach activities using electrical impulses. This neuroblocking technology, called Vbloc, helps to control both hunger and fullness.

    Lewis said he expected the FDA to accept the panel's recommendations and approve the use of Maestro in treating morbid obesity in the second half of the year.

    EnteroMedics' device could help morbidly obese patients, who have few options other than surgery as drugs are of little help to them.

    However, the advisory panel voted against the device's effectiveness, saying 12-month data from a trial did not support its efficacy.

    Lewis said the negative efficacy vote was not representative of the panel consensus that Vbloc therapy showed the necessary clinical benefit, but was based on the data from one trial.

    "Ultimately, the panel determined that 24 percent and 25 percent excess weight loss in the treatment arm at 12 and 18 months ... was clinically significant and effective enough to recommend for approval, regardless of the fact that the ReCharge trial did not meet its arguably flawed co-primary efficacy endpoints," he said.

    Sentiment: Buy

  • equityvaluation equityvaluation Jun 17, 2014 9:38 PM Flag

    This from seeking alpha:

    Favorable Ad Comm vote for EnteroMedics obesity device
    Jun 17 2014, 18:22 ET | About: EnteroMedics Inc. (ETRM)

    The FDA's Gastroenterology and Urology Devices Panel votes 8:1 in favor of the safety of EnteroMedics' (ETRM) Maestro VBLOC Therapy system for the treatment of obesity, but votes 4:5 on the issue of reasonable assurance of efficacy. The final vote, however, was 6:2 recommending approval with one abstention. The FDA usually follows the majority of an Ad Comm vote.
    The Maestro is a pacemaker-like device that delivers VBLOC therapy which controls the hunger sensation and sense of fullness by blocking the primary (Vagus) nerve that regulates the digestive system.
    Shares are up 15% AH on heavy volume.

    Sentiment: Buy

  • From HealthDay:

    FDA Panel Backs Appetite-Curbing Implant for Severely Obese

    Agency committee says nerve-stimulating device may offer more benefits than risks
    FDA Panel Backs Appetite-Curbing Implant for Severely Obese

    By Dennis Thompson
    HealthDay Reporter

    TUESDAY, June 17, 2014 (HealthDay News) -- A new implant designed to curb the appetite by electrically stimulating stomach nerves may have moved closer to U.S. Food and Drug Administration approval on Tuesday.

    The device is aimed at severely obese adults who have failed to slim down using traditional methods, but don't want, or can't have, weight-loss surgery, the manufacturer, EnteroMedics Inc., said in its application for FDA approval.

    The FDA's nine-person Gastroenterology and Urology Devices Panel -- a key advisory committee -- voted 8 to 1 that the Maestro Rechargeable System is safe when used as designed, and 6 to 2 (with one abstention) that the device's benefits outweighed its risks.

    The panel was less decisive on a third vote, on whether the device would be effective for patients: On that vote, 4 panelists voted yes while 5 voted no.

    The FDA is not obligated to follow the decisions of its advisory committees, but it usually does.

    Sentiment: Buy

  • Reply to

    FDA guidance for devices

    by bohemianclubman Jun 17, 2014 5:23 PM
    equityvaluation equityvaluation Jun 17, 2014 7:17 PM Flag

    a steal at $1.84!

    Sentiment: Buy

  • Reply to

    FDA guidance for devices

    by bohemianclubman Jun 17, 2014 5:23 PM
    equityvaluation equityvaluation Jun 17, 2014 6:55 PM Flag

    All the confusion has created a great buying opportunity! After this huge binary event the stock is trading at $1.82 just a few pennies above the closing price. Buyers at these levels have a tremendous bargain imo!

    Sentiment: Buy

  • Reply to

    FDA guidance for devices

    by bohemianclubman Jun 17, 2014 5:23 PM
    equityvaluation equityvaluation Jun 17, 2014 5:52 PM Flag

    Great point! This report may be instructional:
    27.03.2014

    FDA Advisory Committee votes favorably that the benefits of Epi proColon® outweigh the risks

    Berlin (Germany) and Germantown, MD (U.S.A.), March 27, 2014 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced the outcome of a meeting of the Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee held in conjunction with its premarket approval (PMA) for its blood-based colorectal cancer (CRC) screening test Epi proColon®. After deliberations, the members of the Medical Devices Advisory Committee voted positively that the benefits of Epi proColon® outweigh the risks for use in patients who meet the criteria.

    In addition to reviewing the Company's clinical data and the performance of Epi proColon®, the Advisory Committee discussed data presented by the FDA as well as testimonies shared during the public comment session. The committee also discussed risk mitigation strategies that should be considered in addition to the current proposed labeling. The panel voted on three questions. The Advisory Committee members voted 9 to 0 favorably, with one abstention, in assessing whether there is reasonable assurance for safe use of the product in the intended population. The Advisory Committee members were split 5 to 5 in the vote assessing the effectiveness for use of the product in the intended population, with a negative vote from the Panel Chairperson to break the tie. Finally, the panel voted on the question of whether for patients who meet the criteria specified in the proposed intended use, the benefits outweigh the risks for use of Epi proColon®. The Advisory Committee members voted 5 to 4 favorably, with one abstention, supporting the view that the product’s benefits outweigh its risks.

    Sentiment: Buy

  • Reply to

    FDA guidance for devices

    by bohemianclubman Jun 17, 2014 5:23 PM
    equityvaluation equityvaluation Jun 17, 2014 5:35 PM Flag

    The company's press release also highlights the fact that The final vote, on whether the relative benefits outweighed the relative risk, was 6 to 2 "in favor," with 1 abstention.

    Sentiment: Buy

  • equityvaluation equityvaluation Jun 17, 2014 5:27 PM Flag

    T. PAUL, MN--(Marketwired - Jun 17, 2014) - EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the U.S. Food and Drug Administration (FDA) Advisory Gastroenterology and Urology Devices Panel (GUDP) voted 8 to 1 "in favor" that the device is safe when used as designed, and voted 4 to 5 "against" on the issue of a reasonable assurance of efficacy. The final vote, on whether the relative benefits outweighed the relative risk, was 6 to 2 "in favor," with 1 abstention.

    Sentiment: Buy

  • equityvaluation equityvaluation Jun 17, 2014 5:19 PM Flag

    Tweet from StockMatusow ‏@StockMatusow

    $ETRM adcom positive, recommending for approval, but also 4-5 vote against efficacy 6-2-1 benefit to risk

    Sentiment: Buy

  • equityvaluation equityvaluation Jun 17, 2014 5:13 PM Flag

    report from Mass Device...

    Sentiment: Buy

  • FLASH: FDA panel issues mixed vote on EnteroMedics weight-loss implant
    inShare
    June 17, 2014 by Arezu Sarvestani

    An FDA advisory panel votes overall that the benefits of EnteroMedics' Maestro weight-loss implant outweigh the risks, but panel members have some concerns about the effectiveness of the device.
    FLASH: FDA panel issues mixed vote on EnteroMedics weight-loss implant

    EnteroMedics (NSDQ:ETRM) got a mixed bag of support from a panel of FDA advisors today, with most panelists voting that the company's weight-loss implant is safe but raising concerns about the effectiveness of the device.

    The 9-member panel voted that EnteroMedics' Maestro nerve-stimulation implant is safe (8 to 1) and that the overall benefits outweigh the risks (6 to 2 with 1 abstention), but the panel was split on whether the device is effective (5 no, 4 yes). The FDA isn't bound by the recommendations of its advisory panels, but the federal watchdog agency usually sides with them.

    Sentiment: Buy

  • Reply to

    Congratulations!!!!

    by pharmaapproved Jun 17, 2014 4:51 PM
    equityvaluation equityvaluation Jun 17, 2014 5:07 PM Flag

    The favorable risk/benefit and safety -notwithstanding the split vote on efficacy- will win it FDA approval. Let's not forget that the system is available now for commercial use in Australia !

    Sentiment: Buy

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