Guided Therapeutics Inc (GTHP)

[2themoon1]

10-Q today....foolish sellers in my opinion

In the United States, the Company is actively pursuing FDA approval by initiating a clinical trial protocol involving approximately 400 study participants, with the exact number depending in part on the numbers of women in the study both with and without cervical disease. The protocol was drafted with input from FDA and at least two prestigious clinical centers that are participating in the study.
Clinical study monitoring visits are required by FDA to ensure that the study is being conducted under FDA guidelines and in compliance with the study protocol. Findings from the initial clinical study monitoring visits include:


1)
There have not been any adverse events reported related to the use of LuViva.




2)
All three monitored clinical study sites are adhering to the study protocol and are completing the necessary case report forms according to FDA standards.




3)
Enrollment rates have increased during 2024.




4)
Approximately 122 patients have been enrolled and tested.

Based on current and expected enrollment rates, we expect the study to be completed in 2024, however there can be no assurance that the study will progress within the expected timeline.