Medibio Limited provided the following FDA strategy and regulatory update: Sleep Analysis of Depressive Burden study (SADB) (MEB-001). The SADB algorithm development, known as MEB-001, is entering validation trials of the study; and to date, data analysis has demonstrated high levels of performance in overall accuracy, sensitivity, and specificity relative to the current best practice standard for measurement of depression in the US, PHQ-9. The SADB study population has now expanded to include sleep centers in Minnesota, Ohio, North Carolina, South Carolina, Florida, Missouri, and Connecticut to expedite the clinical study timelines. The MEB-001 algorithm has been developed to utilise inputs from FDA-cleared polysomnography (PSG) systems, which are used for sleep studies to diagnose sleep disorders. The algorithm performs a parsing analysis of electroencephalogram (EEG) and electrocardiogram (ECG) biological signals to identify the likelihood of current major depressive episode in patients referring to sleep clinics for sleep disturbances. Thus far, the Company's clinical analysis has shown significant patterns of discrimination for moderate to severe cases of depressive burden 1. Using physiological data (ECG and EEG) collected during a sleep study, MEB-001 utilizes machine learning algorithms to predict the likelihood that the patient is experiencing a current major depressive episode. This prediction is designed to be comparable to a PHQ-9 score >= 10, which is the clinical standard and best practice for screening for a current major depressive event. MEB-001 will report the screening result to the clinician. Development of Software Medical Device (MEB-001SaMD): As a result of the success of the SADB exploratory and late feasibility phase trials, planning has now begun for the development of the cloud-based software medical device platform known as MEB-001SaMD (which incorporates the MEB-001 algorithms). Medibio will seek FDA De Novo approval for the Cloud-based Software Medical Device (MEB-001SaMD) during calendar year 2022. MEB-001SaMD is intended to assist physicians in determining whether a patient should be referred for a more in-depth mental health evaluation. The company believe MEB-001SaMD can ultimately be utilized within the USA by a primary care physician, sleep physician, neurologist, cardiologist, or ENT surgeon, as they are responsible for completing a referral to a mental health professional for evaluation. Medibio is currently in discussions with some of the largest U.S.-based medical insurance carriers to understand and confirm the clinical utility and commercial value to clinicians in the United States. Given these developments, Medibio's clinical staff and its FDA consultants DuVal & Associates are now preparing the documentation required to accompany a request in November 2021 for a pre-submission meeting with the FDA. The purpose of such pre-submission meeting is to obtain FDA feedback on the Indication for Use (IFU), the trial design, its endpoints, the patient trial numbers, and the diversification of the patient population; it will also detail the Intended Use of the MEB-001SaMD and how it will be used in a clinical setting. The proposed FDA validation trial is designed to compare the results from MEB-001SaMD with the results for moderate to severe depression as determined by the PHQ-9 (best practice standard for measurement of depression in the US). Medibio will propose a minimum performance of 65% to satisfy the criteria for study success. However, internal studies have demonstrated higher levels of performance at 75%. The company estimate a total of 370 patients will provide adequate power to satisfy the two primary endpoints.