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EXCLUSIVE: Adial Pharmaceuticals Moves Forward To Second Cohort In Pharmacokinetics Study of AD04 For Alcohol Use Disorder
On Tuesday, Adial Pharmaceuticals Inc (NASDAQ:ADIL) announced the progression to the second cohort in the pharmacokinetics study of AD04. AD04 is the company’s lead investigational genetically ...
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Adial Pharmaceuticals Receives FDA's Positive Feedback On AD04 In Vitro Bridging Strategy
The FDA has confirmed that Adial's proposed strategy, which utilizes data from the AD04-103 study and in vitro dissolution data to demonstrate equivalence between AD04's planned commercial ...
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Adial Pharmaceuticals Receives Positive Response from FDA Meeting Regarding Proposed In Vitro Bridging Strategy for AD04
The FDA’s feedback follows Adial’s submission on November 19, 2024, in which the Company sought the Agency’s guidance on the alignment of its AD04 formulation strategy and bridging approach.