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

Provention Bio Inc (NASDAQ: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.