Clinical Data Timing UncertaintyAnalyst warns that unclear timing of planned study readouts increases uncertainty about when clinical results will generate meaningful catalysts, reducing near-term visibility for investors.
Patent Litigation RiskPending litigation over the '327 patent creates a legal overhang that could disrupt sales continuity, lead to restrictive labeling outcomes, or otherwise impair commercial growth.
Sales Visibility VariabilityAnalyst cautions that seasonal and specialty-pharmacy ordering patterns can create variability in patient starts and prescription flows, producing volatility in short-term sales visibility.