The US Food and Drug Administration (FDA) has rejected an application from Neurotech International to grant orphan drug status for its broad-spectrum cannabinoid treatment for children with neurological conditions.
Neurotech said the FDA believes the two conditions for which it was seeking orphan drug designation (ODD) – Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANDAS/PANS) – “may not constitute the definition of a rare disease in the US”.
Neurotech has 12 months to address the FDA’s concerns.
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