Execution RiskInitiation of the pivotal trial depends on completing regulatory, manufacturing, and operational milestones, so delays or unmet requirements in any area could postpone trial start and development progress.
Financial PositionLimited cash combined with a substantial debt load creates financing pressure that may necessitate additional funding and lead to shareholder dilution.
Formulary And ReimbursementHospitals will demand clear clinical advantage and demonstrable cost savings for formulary inclusion, so failure to show economic benefit could constrain commercial uptake.