Neurotech Pushes Forward Despite FDA Setback

Neurotech International Ltd. (AU:NTI) has released an update.

Neurotech International Ltd faces a setback as the U.S. FDA has declined their request for Orphan Drug Designation for their drug NTI164, targeted at treating PANDAS/PANS, citing uncertainties in disease classification and prevalence. However, the company remains committed to advancing their treatment plans, bolstered by the FDA’s acknowledgment of the strength of their clinical evidence. Neurotech also awaits FDA’s decision on another Orphan Drug Designation request for NTI164 in treating Rett Syndrome, expected before December 2024.

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