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Guided Therapeutics, Inc. (OTCBB OTCQB: GTHP), announced that it held
a productive meeting with U.S. Food and Drug Administration (FDA)
officials to review the company’s premarket approval application (PMA)
for its non-invasive test for the early detection of cervical pre-cancer.
During the meeting with FDA reviewers, which was requested by Guided
Therapeutics, company representatives outlined proposed responses to
recent FDA questions regarding the PMA application and also held
discussions regarding proposed claims for use for the technology.
“We are pleased with the content and outcome of the meeting with our FDA
reviewers,” said Mark L. Faupel, President and CEO of Guided
Therapeutics, Inc. “There was constructive dialog regarding the
questions and our responses. We believe that we came away with clear
guidance and a plan for achieving a panel meeting in the future. We plan
to take what we learned from the meeting and finalize our responses to
the questions in the next two to three weeks.”
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