Liquidity And Funding UncertaintyHigh cash burn and an unclear cash runway could necessitate additional financing, creating execution risk and potential dilution that may hinder commercialization plans.
Manufacturing And Inspection RiskApproval continues to hinge on satisfactory chemistry, manufacturing and controls reviews and facility inspections, which could trigger late-stage regulatory delays or remediation requirements.
Reimbursement And Patient Access BarriersPersistent insurance denials and high out‑of‑pocket costs for off‑label alternatives indicate the potential for payer resistance that could limit patient access and commercial uptake even after approval.