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  • dontdropyourlunch dontdropyourlunch May 9, 2012 7:06 PM Flag

    On conf call guidance must have sucked

    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.