Here's a specific, hour-by-hour action plan for the next 48 hours, considering all the factors you've mentioned:
Day 1:
Hour 1-2: Gather all relevant information
- Meet with your internal research team to get a comprehensive understanding of the side effect, its severity, and the data supporting it.
- Gather all relevant documents and data.
Hour 3-4: Consult with legal and regulatory affairs
- Meet with your legal team to understand the legal implications and liabilities.
- Consult with your regulatory affairs team to understand the reporting requirements and potential penalties for delayed reporting.
Hour 5-6: Ethical and patient safety considerations
- Meet with your ethics committee or a trusted group of external advisors to discuss the ethical implications.
- Consider the potential harm to patients if the drug remains on the market without a warning.
Hour 7-8: Financial implications
- Meet with your CFO to understand the potential financial impact of a stock price drop and the cost of a recall or warning update.
- Discuss potential strategies to mitigate financial damage.
Hour 9-10: PR strategy
- Meet with your PR team to develop a communication plan.
- Consider transparency, honesty, and empathy in your messaging.
- Prepare a statement for the earnings call and a press release.
Hour 11-12: Employee morale
- Draft a memo to employees explaining the situation, the steps being taken, and reassuring them about job security.
- Schedule a town hall meeting for after the earnings call to address employee concerns.
Hour 13-14: Board preparation
- Prepare a presentation for the board meeting, including all the information gathered, the ethical considerations, the legal and financial implications, and the proposed PR strategy.
- Include a recommendation for immediate disclosure.
Hour 15-16: Regulatory relationships
- Reach out to key regulatory contacts to discuss the situation and the potential for expedited reporting.
- Explain your intention to disclose the information immediately.
Hour 17-18: Finalize documents
- Finalize the board presentation, the PR statement, and the employee memo.
- Ensure all documents are accurate, clear, and concise.
Hour 19-20: Rest and prepare
- Take a break to rest and prepare mentally for the board meeting and earnings call.
- Review all documents and presentations.
Hour 21-24: Board meeting
- Present the situation to the board, including all the information gathered and the proposed course of action.
- Address any concerns or questions from board members.
- Aim to reach a consensus on immediate disclosure.
Day 2:
Hour 1-2: Finalize disclosure plan
- Based on the board's decision, finalize the disclosure plan, including the timing and method of disclosure.
- Ensure all departments are prepared for the disclosure.
Hour 3-4: Prepare for earnings call
- Finalize the earnings call script, including the disclosure of the side effect.
- Practice the call with your CFO and PR team.
Hour 5-6: Employee communication
- Send the memo to employees, explaining the situation and the steps being taken.
- Schedule the town hall meeting for after the earnings call.
Hour 7-8: Final regulatory consultation
- Consult with regulatory affairs one last time to ensure all reporting requirements are met.
- Submit any necessary preliminary reports.
Hour 9-10: Final PR review
- Review the PR statement and press release with your PR team.
- Ensure all messaging is clear, honest, and empathetic.
Hour 11-12: Rest and prepare
- Take a break to rest and prepare mentally for the earnings call.
- Review all documents and presentations.
Hour 13-16: Earnings call
- Conduct the earnings call, disclosing the side effect and the steps being taken.
- Address any questions or concerns from investors and analysts.
Hour 17-20: Post-earnings call activities
- Monitor the market reaction and media coverage.
- Address any immediate concerns or questions from employees, investors, or the media.
Hour 21-24: Town hall meeting
- Conduct the town hall meeting with employees, addressing their concerns and reassuring them about job security.
- Provide an update on the situation and the steps being taken.
Reasoning behind each decision:
- Gathering information: It's crucial to have a comprehensive understanding of the situation before making any decisions.
- Legal and regulatory consultations: Understanding the legal and regulatory implications is essential for making informed decisions and avoiding potential penalties.
- Ethical considerations: Patient safety and ethical obligations should be the primary considerations in this situation.
- Financial implications: Understanding the potential financial impact can help in developing strategies to mitigate damage.
- PR strategy: Transparency, honesty, and empathy are key in maintaining trust with patients, investors, and the public.
- Employee morale: Keeping employees informed and reassured can help maintain productivity and morale.
- Board preparation: The board needs to be fully informed to make the right decision.
- Regulatory relationships: Maintaining open communication with regulators can help in navigating the reporting process.
- Finalizing documents: Ensuring all documents are accurate and clear is crucial for effective communication.
- Disclosure plan: A well-thought-out disclosure plan can help minimize damage and maintain trust.
- Earnings call preparation: The earnings call is a critical opportunity to disclose the information and address investor concerns.
- Employee communication: Keeping employees informed can help maintain morale and productivity.
- Final regulatory consultation: Ensuring all reporting requirements are met is crucial for avoiding potential penalties.
- Final PR review: Ensuring all messaging is clear, honest, and empathetic is key in maintaining trust.
- Earnings call: Disclosing the information during the earnings call is the most transparent and efficient way to inform investors and the public.
- Post-earnings call activities: Monitoring the market reaction and addressing immediate concerns can help in managing the situation.
- Town hall meeting: Addressing employee concerns and reassuring them about job security can help maintain morale and productivity.