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Advanced Medical Isotope Corporation Message Board

  • bio1man bio1man Mar 20, 2014 12:49 PM Flag

    When is approval?

    What time frame?

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    • Yes, at least a few months. I would say 5 to 6. Till then enjoy the 24% hike, making a few $G's a week doesn't hurt at all!

    • When is FDA going to respond back?
      Are we looking at a few months?


      • 1 Reply to bio1man
      • When they respond cannot be known until ADMD resubmits a request. The request will either be to consider it as class II device or classIII. If they request the FDA to reclassify it as class II we have to wait for that decision. If the FDA says no, then they resubmit as class III which is 6 months after they submit. If they decide class II it is 3 months again. I have no idea how quickly the FDA will respond to a request to reclassify as class II. But in any case it will take time for ADMD to develop a request. So we have the unknown time period for ADMD to make a request, the FDA time. I would think 6 months is the soonest for radio gel, and it may be a year. But they have indicated they will submit for one of their other technologies soon. I expect them to submit for the seeds in the next month. Therefore if that stays class II it could be approved in as short as 4 months. The seeds and radio gel will be the money makers (the paste probably will not reap much revenues).

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