Commercial OpportunityInvestors now have the goal line for Viaskin Peanut in sight, which is relatively derisked, and can start evaluating the commercial opportunity which could be ~$2B+ annually.
Product Efficacy And SafetyViaskin Peanut's efficacy and safety continue to improve over time in 1-3 year olds, with new analysis supporting its proposed labeling approach.
Regulatory ApprovalThe FDA agreed the safety database from the ongoing Phase 3 VITESSE trial in 4-7 year olds will be sufficient for a BLA submission, allowing DBVT to accelerate its BLA submission.