FDA Update & Key Points: “We are pleased that
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Posted On: 05/13/2024 6:45:51 PM
FDA Update & Key Points:
“We are pleased that the feedback from the U.S. Food and Drug Administration (FDA) supports the advancement of larsucosterol into a single pivotal Phase 3 clinical trial"
"if successful, may serve as the basis for a New Drug Application (NDA) in alcohol-associated hepatitis (AH),” stated James E. Brown, D.V.M., President and CEO of DURECT.
“We are in the process of designing the registrational Phase 3 trial incorporating the FDA’s comments and insights gained from our Phase 2b AHFIRM trial."
"We expect to provide additional details on our planned Phase 3 protocol and present new analyses from AHFIRM later in the year.”
"During a Type C meeting with the FDA, DURECT received feedback on the recommendations for a Phase 3 clinical trial for larsucosterol in AH that could support a potential NDA filing. DURECT is in the process of designing its planned Phase 3 clinical trial based on the FDA feedback and the results from its completed Phase 2b AHFIRM clinical trial."
“We are pleased that the feedback from the U.S. Food and Drug Administration (FDA) supports the advancement of larsucosterol into a single pivotal Phase 3 clinical trial"
"if successful, may serve as the basis for a New Drug Application (NDA) in alcohol-associated hepatitis (AH),” stated James E. Brown, D.V.M., President and CEO of DURECT.
“We are in the process of designing the registrational Phase 3 trial incorporating the FDA’s comments and insights gained from our Phase 2b AHFIRM trial."
"We expect to provide additional details on our planned Phase 3 protocol and present new analyses from AHFIRM later in the year.”
"During a Type C meeting with the FDA, DURECT received feedback on the recommendations for a Phase 3 clinical trial for larsucosterol in AH that could support a potential NDA filing. DURECT is in the process of designing its planned Phase 3 clinical trial based on the FDA feedback and the results from its completed Phase 2b AHFIRM clinical trial."
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