Item 3. Legal Proceedings
Item 3. Legal Proceedings
From time to time, we may be subject to litigation and claims arising in the ordinary course of business. For information about our legal proceedings, see Note 18 to our audited financial statements included elsewhere in this Annual Report on Form 10-K which information is incorporated herein by reference.
In addition, in February 2024, we became aware that the SEC had initiated a formal investigation involving the Company and certain of its directors and officers. This formal investigation relates to the Company’s public disclosures, including about product sales and the receipt of a Form 483 by an investigator at one of the Company’s clinical trial sites in the TRANQUILITY II study, and trading in the securities of the Company. We are cooperating fully with the investigation including producing documents, and current and former officers and employees of the Company have testified before the SEC. We cannot predict or determine whether any proceeding may be instituted by the SEC in connection with its investigation or the outcome of any proceeding that may be instituted, or the effects any such proceeding could have on the Company’s business or financing efforts.
Item 4. Mine Safety Disclosures
Not applicable.
Part II
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