POC Efficacy Study Sample Clauses
POC Efficacy Study. Hairless guinea pig Using the exposure and treatment scenarios as determined in earlier studies, this study will aim at determining the efficacy of NexoBrid in a non-GLP study. [***] Complete study. Study protocol / report submitted to BARDA. [***] [***] 0003
POC Efficacy Study. Mini-Pig (Gottingen) Using the exposure and treatment scenarios as determined in earlier studies, this study will aim at determining the efficacy of NexoBrid in a non-GLP study. [***] Complete study. Study protocol / report submitted to BARDA. [***] [***] 0001
POC Efficacy Study. Mini-Pig (Gottingen) [***], this study will aim at determining the efficacy of NexoBrid in a non-GLP study. Complete study and submit protocol and report to BARDA WBS 1.4 Clinical (Reserved) WBS 1.5 Regulatory WBS 1.5.1 IND WBS 1.5.1.1 FDA Meetings and Requests for Review Under the Animal Rule, FDA will grant review requests for study protocols and reports, as well as at significant milestones.