Medibio Limited (ASX: MEB) has met a major strategic milestone in lodging its Sleep Analysis of Depressive Burden study (MEB-001) algorithm under the Breakthrough Device Designation (BDD) with the FDA.
The achievement for the company to lodge the BDD submission with the FDA for the Sleep Analysis of Depressive Burden study (MEB-001) is a great milestone and it is expected to hear back from the FDA with initial feedback within 60 days from the submission.
The BDD acceptance will ensure a much closer working relationship with the FDA for the approval of the MEB- 001 product. MEB-001 Sleep Analysis of Depressive Burden looking at the biomarkers and physiologic parameters of current major depressive disorder is a new approach to the recognition of depression.
We are pleased to have finalised the MEB-001 BDD submission. This represents the first step for the new Management and Board of MEB in pushing for FDA approval and continuing to develop our core MEB-001 technology,” Non-Executive Chair, David Trimboli, said.