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  1. Pharmboy
    March 27th, 2014 at 12:27 pm

    PGNX/mrm – yes.  Sell puts.

    GTHP – well, the FDA wanted to see more data and the way it was cleaned.

    n the latest regulatory problem for the LuViva Advanced Cervical Scan, the FDA wants new analysis of the device's clinical data and more information on disinfection of the scanner and its optics, according to the company. Guided Therapeutics said it has on-hand information to answer the cleaning and optical questions and will work with the agency on any clinical issues, but the company isn't providing a timeline for approval.

    It is ridiculous that they are holding this back, but it is a new technology and they are paving the way.



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