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The FDA has issued a Complete Response Letter (CRL) to Provention Bio Inc’s (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 pharmacokinetic/pharmacodynamic (PK/PD) 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.
...read full article on Benzinga
