Cervical scanner maker Guided Therapeutics (OTC:GTHP) is preparing to amend its application for premarket approval following a "productive" meeting with FDA officials.
Guided Therapeutics said that it will submit a formal response to address concerns that the federal watchdog agency raised in a September 2013 non-approvable letter for the LuViva scanner. The company tested some of those responses during its face-to-face meeting with regulators.
"The purpose of the meeting was to present the agency with our proposed answers to questions raised by FDA in the September letter and to help clarify our final responses," CEO Gene Cartwright said in prepared remarks. "The meeting was constructive and we were able to put forward our logic and arguments and engage in a detailed discussion with the FDA. We will incorporate our responses and FDA feedback into our formal response, which we plan to file within the next 45 days."
The company got its day with the FDA earlier this month after asking the agency for some face-time to talk about the non-approvable letter.
In January 2013, the FDA refused Guided Therapeutics’ original PMA bid, asking that the company provide additional data on a newer version of the device and make some changes to the study parameters. The company made some progress with regulators and in July 2013 announced that it had an FDA-approved path forward to a PMA for LuViva, a non-invasive scanning system designed to detect disease that leads to cervical cancer.
Last September, Guided Therapeutics revealed that FDA regulators were still not satisfied with its PMA application for the LuViva advanced cervical scanner. The company had been working for months with the bureau to revamp its once-rejected PMA bid, but the FDA had new questions about LuViva. The new queries add to more than 100 questions already answered about the scanning technology, Guided Therapeutics said at the time.