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Epidiolex May Have Avoided CRL Over Metabolite Assessment Due To Unmet Need

 
• By Michael Cipriano

Lead pharmacology/toxicology reviewer said Epdiolex was not approvable because of inadequate assessment of 7-COOH-CBD human metabolite, but supervisor said it could be conducted in postmarketing phase because of the unmet need the drug fills. 

The mellow US FDA advisory committee meeting for GW Pharmaceuticals' Epidiolex (cannabidiol) gave the impression that there were no serious speed bumps in the new drug application (NDA) that could potentially derail an approval.

It appears, however, that the assessment of a supervisory pharmacologist regarding unmet need may have been needed in order for...

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