Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), provided an update on the U.S. Food and Drug Administration (FDA) review process for its premarket approval application (PMA) for the LightTouch™ non-invasive test for the early detection of cervical pre-cancer. The PMA was accepted for filing as of September 23, 2010.
The FDA has inspected two clinical trial sites as part of its review process and raised no formal compliance issues. Advanced Scientifics, Inc. (ASI), the manufacturer of the Company’s single-patient-use disposable patient interface, also reported a successful FDA inspection.
As is typical in the FDA review process, the Company also received a series of questions from the FDA regarding the PMA, covering the clinical trial and various technical issues, for which the Company has 180 days to respond.
“We are pleased with the results of the FDA’s review of our clinical sites and that of our contract manufacturer, ASI,” said Mark L. Faupel, Ph.D., CEO and President of Guided Therapeutics, Inc. “We fully expect to answer the FDA’s questions in a timely manner. Given the timing of the FDA’s inspections and questions, though, it now appears less likely we will be part of the next Obstetrics and Gynecology Devices Panel meeting, tentatively scheduled for May 19-20, 2011.
“Still, we believe it is possible to meet our target for a year end 2011 or early 2012 launch in the U.S. with the next currently scheduled panel meeting date in September, 2011. This would assume the FDA’s questions are answered successfully, any additional inspections also are successful and final approval is granted. Meanwhile, we also continue to work toward an international launch, which could occur prior to approval in the U.S.,” Dr. Faupel said.
Source: Guided Therapeutics