Provention Bio to resubmit BLA for delay of clinical Type 1 Diabetes in at risk patients.

The purpose of the Type B pre-BLA resubmission meeting was to discuss FDA feedback and obtain agreement on Provention's proposed clinical pharmacology data package, including data and analysis from the pharmacokinetic/pharmacodynamic (PK/PD) sub-study completed by the Company to address the FDA's PK comparability considerations contained in the complete response letter (CRL) issued last July. In preliminary meeting comments, the FDA noted that the data package presented does not adequately support PK comparability because predicted primary PK parameters are indicative of a lower exposure. To address this concern, the FDA proposed, and the Company agreed, to use PK modeling to adjust the 14-day dosing regimen for the planned commercial product to match the exposure of clinical material used in prior clinical trials by ensuring that the 90% confidence intervals for relevant PK parameters fall within the target 80-125% range. On this basis, the FDA agreed that Provention could proceed to resubmit the BLA.

Based on the Company and FDA's agreed upon PK modeling, and the Company's experience with various doses and regimens tested in prior clinical trials, the Company will propose in the BLA resubmission a modified 14-day course of therapy to address the FDA's comparability considerations. The BLA resubmission will also include responses to address the CRL's Chemical, Manufacturing, and Controls (CMC) and product quality considerations, as agreed with the FDA at a Type A meeting held in August last year. The Company believes it will be in a position to resubmit the BLA in the first quarter.