BIOXCEL THERAPEUT DL-,001 Forum: Community User: Adler.
„At-Home Setting in Agitation Associated with Bipolar Disorders I and II and Schizophrenia: Type C Meeting on November 8 The Company will review its SERENITY III program with the FDA on November 8, 2023 and plans to discuss the data package required to support submission of an sNDA seeking approval of BXCL501 for the acute treatment of agitation associated with bipolar disorders I and II and schizophrenia in the at-home setting. In addition, the Company plans to discuss the evaluation of the 80 mcg dose of BXCL501 and several potential protocol amendments to the SERENITY III Part 2 trial. The Company identified the 80 mcg dose as more favorable for further development based on pharmacokinetic-pharmacodynamic (PK-PD) modeling anchored by extensive data from studies that evaluated the 60 mcg dose of BXCL501 (half of the lower approved IGALMI™ dose) as well as studies that evaluated the 120 mcg and 180 mcg approved doses of IGALMI™. The primary objective of Part 2 of SERENITY III is to assess safety (the incidence of treatment-emergent adverse events), and the secondary objectives include various efficacy assessments.“ Also wir sprechen vom 8. November, oder gibt es noch was anderes?
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