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Guided Therapeutics, Inc. has received notification from the U.S. Food and Drug Administration (FDA) regarding the pre-market approval (PMA) application for the LuViva Advanced Cervical Scan. In its most recent communication, FDA advised the Company that its PMA amendment, filed in July 2014, was not approvable in its current form. While the agency advised the Company that more patient data would likely be necessary to amend the current application, the agency also stated its willingness to consider alternative approaches to move the product to approvable form.
FDA and the Company intend to meet to discuss the plan for submission of an updated amendment and ultimately reach agreement on steps forward for a path to approval to resolve any remaining data analysis issues. At this meeting, the Company intends to present additional U.S. and international data that the Company believes will further support the clinical benefits of LuViva.
We believed our PMA amendment addressed the remaining questions the agency had about our original application, said Gene...