On February 18, 2020 Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, reported it had achieved significant progress with the U.S. FDA in restarting its efforts for sales and marketing approval of its LuViva Advanced Cervical Scan (Press release, Guided Therapeutics, FEB 18, 2020, View Source [SID1234554459]). After a succession of conference calls, emails and letters exchanged with FDA over the past 30 days, the Company was encouraged by the agency to file a Pre-submission document detailing its approach for a new clinical trial to support U.S. approval. The Company filed Pre-Submission document with FDA on February 17, 2020. The Pre-submission document is designed to elicit comment from FDA regarding the clinical trial so that a study protocol can be completed and the clinical trial started.

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"We have been pleased by FDA’s rapid responses to our plan for moving ahead with the approval process, which has allowed us to complete the initial phases of the study design ahead of schedule," said Gene Cartwright, CEO. "If our plan is accepted by FDA, we expect to complete and file the study protocol for comment within about 30 to 60 days, depending on how rapidly FDA responds to our recently filed Pre-submission document."