Investor Confidence RiskRegulatory setbacks and extended review cycles can erode investor confidence and increase stock volatility, which may hinder future financing or strategic initiatives.
Regulatory Process UncertaintyRequired resubmission and appeals introduce uncertainty around approval timing and final regulatory requirements, complicating product launch planning.
Regulatory RejectionA Not Substantially Equivalent decision from the FDA represents a direct regulatory setback that can prevent or delay clearance for the ECG synthesis software.