Main risks
Despite the promising results obtained in animal models, the transition from the preclinical to the clinical phase remains a complex process. Adjustments will be necessary to refine toxicity assessment, optimize the administration regimen, and determine long-term effects, particularly in the context of chronic treatment in children. Moreover, while these rare neurological diseases represent an unmet medical need, market access and adoption may require lengthy and complex negotiations. Treatment costs, integration into healthcare systems, and gradual adoption by clinicians will be key factors in ensuring the commercial success of AtmosR's solution.