Clinical Trial Outcome RiskFailure to achieve the primary effectiveness endpoint on time to a second generalized tonic‑clonic seizure increases regulatory uncertainty and may limit the scope of any approval.
Commercial And Distribution RiskNonrenewal of the distribution agreement with DIXI Medical may reduce market reach and put pressure on near‑term revenue until alternative commercial channels are established.
Reimbursement And Labeling UncertaintyMixed trial outcomes, with missed primary endpoint despite positive secondary results, could complicate pricing discussions and reimbursement decisions with payers.