Provention Bio, Inc. is making some headway in its efforts to unblock the regulatory passage of its potential immunotherapy, teplizumab, following receipt in July of a complete response letter, and plans to request a fourth quarter 2021 Type A meeting with the US Food and Drug Administration to discuss the way forward for the anti-CD3 monoclonal antibody.
The biotech is busy collecting fresh data after receiving the complete response letter regarding its filing for teplizumab as a...