Market VolatilityShares could experience significant volatility as investors position for potential FDA flexibility around the totality of the data and await definitive regulatory feedback, raising downside risk for short-term holders.
Priority Review Voucher EligibilityEligibility for the Priority Review Voucher is uncertain because governing legislation may not be renewed, which could eliminate a projected source of non-dilutive cash and worsen the company's liquidity position.
Regulatory UncertaintyOutstanding questions about trial population composition, representation of background cardiac medications, manufacturing controls, and additional mechanism-of-action data could trigger further FDA inquiries or requirements and increase execution risk.