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Given ImAŞing Ltd. Şti. Message Board

  • dontdropyourlunch dontdropyourlunch May 9, 2012 11:49 AM Flag

    On conf call guidance must have sucked

    I have not listened to the conf call this morning. Looks like during the conf call perhaps forward guidance from the CEO must have been poor.

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    • They reaffirmed their previous guidance for the year.

      IMO it's selling off because the Colon2 approval process is taking too long; apparently they will be done with the studies by June, then will evaluate the results for a few months and if they are positive as they 'expect', then they will submit to FDA for approval and god knows how long FDA will take to approve it {assuming results are positive}

      I bought the stock, hoping for PillCam Colon approval in U.S. This was 5 years ago!

      • 1 Reply to marmoolak14
      • marmoolak, I still have not listened to the conf call, but thanks for the information. If results of the Colon 2 trial data are positive, it won't take the FDA too long to grant a 510(k) approval. I assume 510(k) is what GIVN is going for with the FDA. The PillCam is not a life or death type medical device, and even if something happens to a patient, extracting the PillCam with external assistance is not something the FDA will judge as life threatening. The PillCam is not anything like an artificial heart implant. Anything that allays the patient fright of today's colonoscopy that can get people into the doctor's office for a PillCam exam instead, the FDA will be very pleased with.