Approval UncertaintyDespite multiple recent approvals, unmet need in DMD remains high, suggesting plenty of room for deramiocel and other new therapies to make an impact.
Market CompetitionDespite recent approvals, the unmet need in the DMD market remains significant, providing an opportunity for deramiocel to fill this gap.
Regulatory ChallengesPotential hurdles include whether the FDA will require additional data, manufacturing issues, and the possibility of an AdCom.