Medibio Limited
(ASX:MEB) says it has completed a positive pre-submission meeting with the US FDA on its proposed diagnostic for depression.
The company received confirmation from the FDA regarding its proposed indications for use, clinical study protocols and data requirements.
The FDA also confirmed that the Mediobio Depression Algorithm is eligible for a de novo regulatory pathway and there were no significant concerns with it.
The company says the confirmation of the regulatory pathway is an important milestone for the company.
Mediobio reported a net loss of $1.03 million at 31 December 2015.
