Confounding MedicationsBackground use or changes in anti-arrhythmic medications can create the appearance of efficacy in small studies, complicating assessment of the therapy's true benefit without medication normalization.
Efficacy InconsistencyKey arrhythmia measures have not reliably improved within the same patients, raising concern that reported average improvements may not reflect consistent individual-level benefit.
Safety And Regulatory RiskA new or worsening safety signal, combined with data-driven investor positioning, could significantly weaken the investment thesis, reduce approval probability in models, and increase stock volatility toward the support offered by existing assets.