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# Provention Bio Plans Rolling BLA for 2020
- URL: https://www.fdaweb.com/provention-bio-plans-rolling-bla-for-2020/
- Published: 2019-12-12T12:00:00.000Z
- Updated: 2026-09-14T15:56:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145717

Provention Bio says that as a result of a meeting with FDA staff to discuss the proposed contents of a BLA for its PRV-031 (teplizumab) for prevention or delay of Type 1 diabetes in at-risk individuals, it expects to open a rolling BLA submission mid-2020 and complete the submission in the fourth quarter. The company [says](https://www.marketwatch.com/press-release/provention-bio-reiterates-regulatory-guidance-for-prv-031-teplizumab-following-meeting-with-the-fda-2019-12-12?ref=fdaweb.com) it does not anticipate the need to conduct any additional clinical trials in the at-risk population before the BLA submission.