Commercialization CapabilityStatement that the company is not positioned to advance govorestat to commercialization increases the risk of development delays or the need to secure a new developer.
Operational And Leadership DisruptionSignificant workforce reductions and the executive chairman's departure suggest operational strain and leadership disruption that could impede program execution and cash preservation efforts.
Regulatory And Clinical UncertaintyUnresolved questions on disease biology, acceptable surrogate endpoints, pivotal trial design, and carcinogenicity testing create significant uncertainty around any approval pathway.