 The FDA has issued a Complete Response Letter CRL to Provention Bio Incs NASDAQ: PRVB teplizumab marketing application seeking approval for the delay of clinical type 1 diabetes T1D in at-risk individuals. The FDA stated that a single, low-dose pharmacokineticpharmacodynamic PKPD bridging study in healthy volunteers to compare planned commercial products with drug product originating from drug substances manufactured for historical trials had failed to show PK comparability. 