Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies

The eighth installment of Ropes & Gray’s podcast series Non-binding Guidance looks at SEC disclosure issues for life sciences companies. In this episode, Ropes & Gray partners Kellie Combs and Emily Oldshue discuss when to disclose, how to frame the disclosure, and how the responses to both of these questions are informed by SEC enforcement actions and securities litigation, as well as their experience working with life sciences companies in various stages of development. Emily and Kellie will dive into how to craft SEC disclosures involving a variety of FDA regulatory issues, such as clinical trial results, adverse findings from regulatory audits and inspections, and FDA interactions that occur during review of a pending application or post-market.