Guided Therapeutics files LuViva PMA amendment

In response to the FDA's September 6, 2013 not-approvable letter, Guided Therapeutics (OTCQB:GTHP +0.8%) files an amendment to its PMA application for the LuViva Advanced Cervical Scan. The company believes it addresses all the agency's questions.

The regulator has 180 days to respond.

LuViva is currently approved for sale in Europe, Mexico, Canada and Singapore.

Comments (2)
  • Joe2922
    , contributor
    Comments (488) | Send Message
    Luviva has been approved in 27 nations with several more pending.
    See IV message board for quick links to company website-news, recent Markum CEO presentation audio/visual, etc:
    Sales are expected to quadruple in 2015 compared to 2nd quarter 2014; company guidance is $4-8M. 90% margins on single-use disposables.
    28 Jul 2014, 03:25 PM Reply Like
  • mmalik4056
    , contributor
    Comments (75) | Send Message
    Any update on your perspective? It seems like they like to give overly optimistic guidance and without FDA approval, the stock has languished
    18 May, 03:00 PM Reply Like
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