• Interim results (unblinded) shared with OWS • OWS therapeutic efforts headed by Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA • Review of all submissions and correspondence to FDA • OWS FDA SME attendance at company meetings with FDA • OWS will be included as a Named Contact on all FDA filings • OWS concurs with expansion of the Phase 3 study and path forward