Provention Bio Inc

+0.16 (+2.42%)
Products, Regulatory

Provention Bio Provides Update On The Potential Timing Of Teplizumab At-Risk Type 1 Diabetes (T1D) Biologics License Application (BLA) Resubmission

Published: 09/13/2021 11:55 GMT
Provention Bio Inc (PRVB) - Provention Bio Provides Update on the Potential Timing of Teplizumab At-risk Type 1 Diabetes (t1d) Biologics License Application (bla) Resubmission.
Provention Bio Inc - Data Collection Completed for Protect Pharmacokinetic/pharmacodynamic (pk/pd) Substudy.
Provention Bio Inc - Working With U.S. FDA to Finalize Design of Population Pk Model to Be Used to Analyze Substudy Data.
Provention Bio Inc - Plans to Request a Q4 2021 Type a Meeting With U.S. FDA to Obtain Approval to Proceed With Unblinding.
Provention Bio - Believes Preliminary Top-line Study Analysis of Clinically Relevant Pd Data Are Supportive of Comparability.
Provention Bio - Continues to Believe Product Quality Crl Considerations Have Already Been Addressed by Prior Amendments to Bla Or Are Addressable in Short Term.