Efficacy Skepticism And Approval RiskPublic skepticism from influential regulatory figures about the drug's efficacy could prompt added scrutiny or requests for more data, increasing the risk of approval delays or conditional requirements.
Market Reaction And Valuation PressureNotable share-price declines following media coverage suggest the market may have already discounted regulatory benefits, limiting upside until clearer, positive regulatory milestones are achieved.
Regulatory Politicization And Media RiskUnconfirmed articles alleging political interference in drug review processes create regulatory uncertainty that could undermine investor confidence and complicate the approval narrative.