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SEC Disclosure Issues for Life Sciences Companies

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Manage episode 346370706 series 3413447
Content provided by Ropes & Gray LLP and Gray LLP. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Ropes & Gray LLP and Gray LLP or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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.
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36 episodes

Artwork
iconShare
 
Manage episode 346370706 series 3413447
Content provided by Ropes & Gray LLP and Gray LLP. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Ropes & Gray LLP and Gray LLP or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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.
  continue reading

36 episodes

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