FDA Gives Green Signal To Provention Bio's Delaying Diabetes Med Resubmission

Provention Bio Inc PRVB said that it had resolved the comparability concerns with the FDA, and teplizumab is clear for resubmission. 

• The resubmission should be ready to go in Q1 of FY22.
• After discussions with the FDA, Provention agreed to use pharmacokinetic modeling to adjust the 14-day dosing regimen for the commercial product to match the exposure seen with the material used in the treatment's clinical trials. 
• The Company will propose a modified 14-day course to address the FDA's concerns.
• The resubmission will also include responses to the FDA's questions about chemical, manufacturing, and controls, along with product quality considerations. The type A meeting was held in August last year.
• The therapy narrowly passed the vote at an FDA advisory committee meeting in May last year amid questions about the small study size and more. 
• The FDA hit teplizumab with a complete response letter, rejecting the application. 
• The agency questioned data related to the drug substance to be used in the commercial product and asked for a safety update in a resubmission.
• Price Action: PRVB shares are up 11.8% at $3.80 during the premarket session on the last check Friday.