Launch Timing RiskThe FDA's extended review following a major amendment delays potential market launch and increases uncertainty around revenue timing, raising event‑driven risk for the stock.
Manufacturing And Regulatory ExecutionOutstanding chemistry and manufacturing reviews, potential inspections, and the risk of labeling or manufacturing issues represent material regulatory and execution risks that could impede approval or commercialization.
Reimbursement And Adoption HurdlesPersistent insurance denials, high patient copays, and reliance on whole lung lavage as the standard initial treatment could limit patient access and constrain uptake even after an approval.