Ethical Dilemma with Stakeholders

Hour 1-4: Immediate Assessment and Advisory Setup

• Hour 1: Gather the internal research team for an emergency meeting to confirm findings, assess the robustness of their data, and understand the methodology used to identify this side effect. Ensure all documentation is in order.
• Hour 2: Schedule an urgent, confidential consultation with external hepatology and pharmacology experts to validate the internal findings.
• Hours 3-4: Assemble a crisis management team including heads of Legal, Compliance, Medical Affairs, PR, and Investor Relations. Assign roles and responsibilities.

Hours 5-12: Parallel Processing and Initial Actions

• Hour 5: Notify your Executive Committee (excluding dissenting board members) about the issue to ensure full transparency at the top and to start aligning on a unified approach.
• Hours 6-8: Have the Legal team begin preliminary work on regulatory filings, but hold off on formal submission pending further validation. Start drafting communication templates for patients, healthcare providers, and regulators.
• Hours 9-10: Work with Medical Affairs to outline a plan for patient outreach and support, including setting up a hotline for patient inquiries and concerns.
• Hours 11-12: Formulate an initial internal communication plan for employees to prevent rumors and ensure they are informed appropriately when the time comes.

Hours 13-24: Data Validation and Strategic Planning

• Hours 13-16: Review findings from the external experts. Confirm or refute the internal data with their independent analysis.
• Hours 17-18: If validated, convene another meeting with the crisis management team to reassess the situation and finalize a recommendation for the board.
• Hours 19-20: Draft a comprehensive report for the board, including data, potential impacts (financial, legal, ethical), and recommended actions.
• Hours 21-24: Work with PR and Investor Relations to develop a proactive communication strategy, anticipating various scenarios (leaks, regulatory announcements, etc.).

Hours 25-36: Board Preparation and Final Validation

• Hour 25: Call an informal, confidential meeting with key board allies to pre-brief them and gather support for transparent disclosure.
• Hours 26-30: Refine the board report and presentation based on feedback from the crisis management team and key board allies.
• Hours 31-33: Conduct a final review with legal counsel to ensure compliance with all regulatory obligations and prepare for potential questions.
• Hours 34-36: Hold mock Q&A sessions with the crisis management team to prepare for the board meeting and potential media inquiries.

Hours 37-48: Final Steps Before the Board Meeting

• Hour 37: Send the finalized board report to all board members, emphasizing the urgency and the importance of ethical considerations.
• Hours 38-42: Arrange individual calls with the three dissenting board members to understand their concerns, provide additional data, and seek a consensus.
• Hours 43-45: Finalize logistics for the board meeting, ensuring secure and confidential access to all relevant documents and presentations.
• Hours 46-48: Review all materials one last time. Ensure you are prepared to address all potential concerns and questions from the board with data, ethical arguments, and a solid action plan.

Reasoning:

• Legal and Ethical Obligations: Prioritize patient safety and ethical responsibility by validating data and consulting experts before taking any action.
• Financial Implications: Balance transparency with the need to manage financial impact by preparing a robust PR and investor relations strategy.
• Regulatory Relationships: Engage with regulators appropriately after thorough validation to maintain credibility.
• Employee Morale: Keep employees informed through a controlled internal communication plan.
• Board Dynamics: Address dissenting board members individually to align on a unified approach, emphasizing long-term reputation over short-term financials.

The 48-hour window is used to validate findings, align stakeholders, and prepare for transparent disclosure, minimizing risks and adhering to ethical standards. Delaying formal regulatory action for a short period is acceptable if it ensures accuracy and comprehensive preparation, but transparency must remain the ultimate goal to uphold trust and integrity.