ADIL - Adial Pharma drops 3% as FDA rejects Fast Track request for AD04

Adial Pharmaceuticals (ADIL) down 3% premarket after FDA rejected its request for Fast Track Designation for AD04, for the treatment of Alcohol Use Disorder ((AUD)) in pediatric and adult patients with Alcoholic Liver Disease ((ALD)) with select polymorphisms of the serotonin transporter and receptor genes.The FDA stated in its letter that the Company has not yet demonstrated that the product shows potential to address an unmet medical need in the situation where other treatments are available.Additionally, the FDA stated additional information would be required regarding how AD04 might compare to other therapies if the Company desires further consideration.Based on this feedback, Adial will review the additional requirements and data requested by the Agency.Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

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Adial Pharma drops 3% as FDA rejects Fast Track request for AD04