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EnteroMedics Inc. Message Board

  • bohemianclubman bohemianclubman Jun 17, 2014 5:23 PM Flag

    FDA guidance for devices

    Well perhaps out of pure confusion I went to the FDA website and read the guidance for getting medical devices approved and to my surprise, and I suppose joy, it does appear as though benefit/risk is their number one concern regarding rendering a decision!!

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    • Based on FDA guidance document for medical devices, the Fda should approve the device based upon the risk benefit ratio vote,

      Sentiment: Hold

      • 2 Replies to kenneth.girouard
      • But it would be THEIR estimate of the risk/benefit profile (as influenced to whatever extent by the panel vote), NOT just the panel vote wholesale. And the FDA goes against panel recommendations, both ways, plenty of times.

        Also, that Guidance Doc from 2012 is sort of stale - so be careful with jumping to conclusions. The draft was from 8/2011 -- there was a major workshop on obesity devices months later that year and then a policy panel in May of 2012 afterwards as well, and then there was Lerner's article and then in 2013 his update presentation to the AGA.

        With Lerner on the FDA side of this, and their expert on the necessary evolving standards for obesity devices, his presentation of that update will carry the greatest weight --- and he represented an FDA evolution towards 8%TBL (not EWL) over sham. Maestro only saw 3.3%TBL over sham and this data obviously weighed in heavier than the 18-month data (as I also told the board it would) because efficacy got an overall ding.

        You have to worry that FDA-side thinking is going to be more like their expert's on obesity devices than it will be the panel-side thinking.

      • 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

    • 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

    • 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

    • http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf

      I always go back to p.13 and 14

    • Can you provide a link here?

 
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