Washington, DC Partner Liz Gray will be presenting, “Reacting to Scrutiny of Clinical Trial Disclosures by the SEC,” at the American Conference Institute’s 7th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials in San Francisco on July 16.
Specifically, she will discuss:
- How FDA and SEC cooperation (Referral Process and Centralized Procedures) have affected scrutiny of clinical trial disclosures
- Complying with SEC reporting requirements pre- and post-approval
- Reconciling FDA/SEC disclaimer requirements
- Factoring in recent enforcement activities by the SEC and FDA
- Lessons learned from ImClone, TKT, ICN, and NY Executive Law 63(12)
- Disclosing clinical trial information that has been made available to the FDA but not publicly disclosed
- Determining what FDA actions to disclose and how to disclose them for accurate interpretation by the securities market
- Alleviating securities concerns: whether databank entries constitute “forward-looking statements” for investor reliance; and
- Controlling and monitoring material inside information and disclosing material facts to shareholders
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