Monday, December 20, 2021 2:58:39 PM
The bad news: Failing to properly disclose material events regarding clinical trial data may result in more than harm to company’s reputation. It could lead to an investigation by the SEC and/or DOJ if the agencies believe that the company has intentionally deceived investors. The FDA may assist these inquiries, and in fact, the FDA and SEC now have a specified mechanism in place that facilitates FDA reporting to the SEC if they come to believe that a company may have made a false or misleading statement to the investors. SEC and DOJ investigations pose a much graver risk than ordinary commercial litigation, as consequences may include substantial fines for the company and its executives, bars on serving as an officer at a publicly traded company for a period of time, and, in extreme cases, criminal prosecution including potential jail time.
https://westwicke.com/2019/11/keys-to-successful-disclosure-of-clinical-trial-data-and-milestones/
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