Financing And Competitive PressuresPotential future equity raises risk diluting existing shareholders, while trailing an established competitor in the same class may limit market share even if approval is achieved.
Limited Trial Size And Statistical UncertaintySmall patient numbers in early studies constrain confidence in the observed efficacy signals and leave meaningful clinical risk until larger trials confirm results.
Long-term Safety And Regulatory RiskAdditional safety data are required to confirm long-term tolerability, and unresolved safety questions could complicate regulatory review and physician acceptance.