Device Bridging RequirementA required bridging study to demonstrate comparability of the proprietary aerosol delivery device must be completed before the pivotal program can start, making it a key gating factor for global development.
Financing And Execution RiskThe development plan assumes additional financing, exposing investors to potential dilution while remaining clinical, commercialization, and pricing uncertainties could pressure returns.
Regulatory Design UncertaintyProgress depends on securing clear FDA agreement on Phase 3 trial design, creating regulatory uncertainty that could delay program timeline and increase development risk.