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Titan Pharmaceuticals Inc. Message Board

  • zero.risk13 zero.risk13 Apr 10, 2014 11:39 AM Flag

    GTHP: May 8th FDA Meeting Followed by an Immediate Response

    The cervical cancer scan market is huge. A 10 bagger after FDA approval this year?
    (Already approved in EU, Canada, Singapore......)

    "Guided Therapeutics, Inc. (GTHP) (GTHP) today announced that the company has been given a face-to-face meeting date of May 8, 2014, by the U.S. Food and Drug Administration (FDA), to discuss the company’s response to the September 6, 2013 not-approvable letter that the company received from the agency.

    “These face-to-face meetings are an important part of advancing the review process and we are pleased that the FDA has responded so quickly to our request for the meeting,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “After the meeting, we plan to submit our formal, written response to questions in the September 6, 2013 letter.”

    “Meanwhile, we continue to focus on growing sales for LuViva in international markets and working to expand its application in developing countries to include screening for cervical cancer,” Mr. Cartwright said.

    The company has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, has marketing approvals from Health Canada and Singapore Health Sciences Authority and has filed for approval in Mexico. Additionally, expansion efforts are ongoing in the Middle East, Asia, Africa and Latin America."

 
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