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Epidiolex Nonclinical Review Summary by P Ranavp is a document available to read on EtoBox.

What is Epidiolex Nonclinical Review Summary about?

The document reviews the nonclinical data submitted for NDA 210365, which pertains to cannabidiol as an adjunctive treatment for seizures in patients with Lennox Gastaut or Dravet Syndrome. A significant deficiency was identified regarding the assessment of a major human metabolite, 7-COOH-CBD, which led to the conclusion that the application cannot be considered approvable at this time. It was suggested that nonclinical studies on this metabolite could be conducted post-marketing if clinical data support a

Author

P Ranavp

Language

EN