Market OpportunityGiven the regulatory clarity, investors 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 EfficacyViaskin Peanut provides ample protection to peanut exposure, coupled with its clean safety and convenient administration, making it a blockbuster opportunity.
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.