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Re: dennisdave post# 427963

Monday, 12/20/2021 2:58:39 PM

Monday, December 20, 2021 2:58:39 PM

Post# of 701595
Statements made by life science and medical device companies are thoroughly scrutinized by the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ), since investors rely heavily on these disclosures when making their investment decisions. Mistakes made while disclosing events of the clinical trial lifecycle can cause a serious crisis for your company: analysts may downgrade your stock, investors may dispose of your shares, and your stock price may plummet. Such errors will also harm management’s credibility and reputation, your company’s most valuable attributes.

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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