BioXcel Therapeutics Inc.
08/15/2025 | Press release | Distributed by Public on 08/15/2025 07:19
Material Event (Form 8-K)
| Item 8.01 | Other Events. |
On August 14, 2025, BioXcel Therapeutics, Inc. (the "Company") received positive preliminary meeting comments from the U.S. Food and Drug Administration (FDA) related to the pre-sNDA meeting scheduled for August 20, 2025. The Company is evaluating the feedback from the FDA and plans to provide an update next week.
The primary purpose of the planned pre-sNDA meeting is to gain alignment with the FDA regarding the proposed format and content of the Company's planned sNDA submission, including the clinical, nonclinical and chemistry, manufacturing and controls (CMC) requirements.
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