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Advanced Medical Isotope Corporation Message Board

  • zippy_icon zippy_icon Jun 25, 2013 8:11 PM Flag

    FDA date on RadioGel

    Hi Everyone,

    I have been following ADMD for the last couple of months and like most of you, I am not happy with the way things are going. Its really hard to do DD on something you can not find enough materials on and you have no option but to rely completely on luck. I was lured by the price of the stock which made me pull the trigger. However the downhill seems to be an ongoing process and it appears to never stop. Has anyone in the past done studies on this company and can provide us some insight. I was also interested to know about the FDA date on RadioGel, do we have a tentative date? How long does the process take? The only information I could find was from an SA article.

    "While ADMD's core business lies in the manufacturing and distribution of medical isotopes, the company recently decided to enter the brachytherapy market with a novel device called "RadioGel". On February 5th of this year, ADMD announced that the company had submitted data to the FDA on RadioGel as the initial step in a pre-market review, and requested a collaborative meeting with the agency. I wasn't able to get an estimate on the timeframe for FDA review of RadioGel, but instead was informed by the agency that they cannot currently comment on a device that is "under-review". Based on historical precedence, however, I think RadioGel could be approved before the end of 2013".

    Please share thoughts.

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