Pre‑revenue, Heavy LossesPersistent pre‑revenue status and large, sustained operating losses create structural financing dependence and dilution risk. Reliance on external capital can constrain strategy, force timing compromises, and make execution contingent on fundraising windows, which is a lasting financial vulnerability until commercial revenue materializes.
Pending Pivotal 26‑week DataThe final 26‑week dataset is a structural gating item for completing the NDA; any delay or adverse signal would directly postpone submission and approval. This single pivotal dependency affects regulatory timing, labeling, and payer evidence packages, making it a durable execution risk until results are public and accepted by regulators.
Reimbursement & REMS UncertaintyCategory III CPT status, pending RUC valuation, undefined REMS requirements and expected payer prior‑authorization create structural reimbursement and access risk. Until billing codes, RVUs and REMS are finalized, per‑patient revenue, site economics and uptake remain uncertain, potentially limiting commercial penetration and margins.