Well done Medibio. Hopefully the results of the confirmatory...

Well done Medibio.


Hopefully the results of the confirmatory study will also be released in the coming weeks.

From March 2018 quarterly: "Medibio completed the enrollment of all participants in the MB-DEPDX04 FDA study that was initiated in September 2017. The study includes clinical sites located in both the United States and Australia with a total enrollment of 271 subjects. The next stage of the study will include close-out activities and data analysis of completed subjects."

From 21 August 2017 announcement: "Medibio Limited (MEB or the Company)(ASX: MEB)(OTCQB: MDBIF), a digital health company that has developed an objective testing system to assist in the screening, diagnosis, and treatment effectiveness of depression and other mental health disorders, is pleased to announce the commencement of its Depression Diagnostic confirmatory study. The study will serve as the centerpiece of the company’s FDA 510(k) De Novo submission in Calendar Q2 next year. The preceding exploratory study demonstrated excellent performance of the Depression Diagnostic, with overall accuracy of 82%, specificity of 84%, and sensitivity of 78%. FDA input was heavily incorporated into the design of the exploratory study, which was conducted to de-risk the confirmatory study and to optimize its timely execution. The current study design replicates the framework of the exploratory study, using the same endpoints (sensitivity, specificity, and repeatability) and the same methodology (comparing Depression Diagnostic classification to the gold-standard of structured clinical interviews for diagnosis). The sample size of the study has been scaled to meet FDA expectations for generalizability, and the study cohort will be split evenly between individuals with Major Depressive Disorder (MDD) and non-depressed controls."