Hour 1-2: Immediate Review and Verification (Now - 1 hour)
- Summon the internal research team to confirm the findings, understand the methodology, and assess the confidence level of the results.
- Ask the team to provide a detailed report, including the estimated incidence rate of liver failure, and any potential correlations with patient demographics or concurrent medications.
Hour 3-4: Consult with Senior Leadership (1-2 hours)
- Meet with the CFO, CMO, and General Counsel to discuss the potential implications of the discovery.
- Review the current financial situation, including the upcoming earnings call, and assess the potential impact on the stock price.
- Discuss the legal and regulatory requirements for reporting adverse events.
Hour 5-6: Inform the Board (2-3 hours)
- Notify the Board Chair and the three members pushing to "wait for more data" about the situation, providing a concise summary of the findings.
- Schedule an emergency Board meeting for 24 hours from now to discuss the matter further.
Hour 7-12: Regulatory and Legal Review (3-6 hours)
- Consult with the regulatory affairs team to understand the formal reporting requirements and potential timelines.
- Meet with external counsel to review the company's legal obligations and potential liabilities.
- Discuss the possibility of expedited reporting to regulatory agencies.
Hour 13-18: Communication Strategy (6-9 hours)
- Develop a draft communication plan for stakeholders, including patients, physicians, investors, and employees.
- Prepare a press release and Q&A document addressing the situation.
- Identify a spokesperson and media training needs.
Hour 19-24: Board Meeting Preparation (9-12 hours)
- Prepare a comprehensive presentation for the Board meeting, including:
- The research findings and estimated incidence rate of liver failure.
- The potential financial implications of disclosure.
- The regulatory and legal requirements for reporting adverse events.
- The proposed communication strategy.
- Anticipate and prepare responses to potential Board questions and concerns.
Hour 24: Emergency Board Meeting (12 hours)
- Present the findings and proposed plan to the Board.
- Address concerns and questions from the Board members.
- Seek a Board resolution to move forward with expedited reporting and communication.
Hour 25-48: Finalize Communication Plan and Regulatory Reporting (12-24 hours)
- Refine the communication plan based on Board feedback.
- Finalize the press release, Q&A document, and other communication materials.
- Prepare the regulatory report and submit it to the relevant agencies, if possible.
Rationale:
- Patient safety: The primary concern is the potential harm to patients taking the medication. By acting swiftly, we can minimize the risk of further adverse events.
- Regulatory compliance: We must comply with regulatory requirements for reporting adverse events, even if it's expedited.
- Transparency and ethics: Disclosing the information promptly demonstrates our commitment to transparency and ethics, which is essential for maintaining public trust.
- Financial implications: While a 40% stock price drop is significant, delaying disclosure could lead to even greater financial consequences, including potential lawsuits and reputational damage.
- Employee morale: Open communication and transparency with employees will help maintain trust and morale.
- PR strategy: A proactive communication approach will help mitigate the negative impact on our reputation and stock price.
- Regulatory relationships: By working closely with regulatory agencies, we can demonstrate our commitment to cooperation and compliance.
In the next 24 hours (after the Board meeting), the focus will shift to executing the communication plan, submitting the regulatory report, and addressing any emerging issues.