48-Hour Crisis Response Plan

Hour 1-2: Immediate Assessment & Core Team Assembly

Actions:

• Convene emergency leadership meeting (CMO, General Counsel, Head of Regulatory, CFO, Head of Communications)
• Establish secure communication protocols and confidentiality agreements
• Request detailed analysis from research team: statistical confidence, causality assessment, patient demographics affected

Reasoning: Need full picture before making irreversible decisions. This isn't about delay—it's about ensuring we have accurate information for the right response.

Hour 3-6: Data Validation & Medical Review

Actions:

• Bring in independent medical experts (not company employees) for urgent review
• Cross-reference with post-market surveillance data and adverse event reports
• Analyze if there are identifiable risk factors that could enable targeted warnings
• Legal team to research precedents and liability exposure for delayed vs. immediate disclosure

Reasoning: We need to distinguish between a statistical anomaly and a genuine safety signal. The 1-in-8,000 rate over 5 years needs validation—this affects 500 current patients potentially.

Hour 7-12: Strategic Decision Framework

Actions:

• Calculate scenarios: immediate disclosure, 30-day expedited review, 6-month standard timeline
• Assess patient risk mitigation options (enhanced monitoring protocols, risk factor screening)
• Draft multiple versions of disclosure documents
• Begin preliminary discussions with key institutional investors (under NDA)

Reasoning: We need optionality. The board members pushing to "wait" may be right if we can implement immediate risk mitigation while conducting accelerated review.

Hour 13-18: Regulatory Strategy

Actions:

• Informal consultation with FDA (without formal submission) to understand expedited pathways
• Prepare for potential voluntary recall vs. enhanced warning scenarios
• Document all decisions and rationale for legal protection
• Begin drafting updated prescribing information

Reasoning: Regulators often appreciate proactive engagement. This positions us as responsible while buying time for proper analysis.

Hour 19-24: Stakeholder Preparation

Actions:

• Prepare three-tier communication strategy: immediate patient safety letter, enhanced warnings, full disclosure
• Draft talking points for board meeting emphasizing patient safety primacy
• Calculate financial reserves needed for potential litigation/settlements
• Prepare employee communication about our commitment to safety

Reasoning: We need to control the narrative around patient safety, not financial concerns.

Hour 25-36: Board Preparation & Decision

Actions:

• Present board with full risk assessment and recommend immediate enhanced warnings with 30-day accelerated review
• Propose compromise: implement patient risk mitigation immediately, full disclosure in 30 days max
• Get board approval for enhanced monitoring program and patient notification
• Authorize CFO to prepare for earnings impact disclosure

Reasoning: This balances patient safety (immediate risk mitigation) with fiduciary duty (avoiding premature disclosure of uncertain data).

Hour 37-48: Implementation Preparation

Actions:

• If board approves enhanced warning approach: begin immediate implementation
• Prepare healthcare provider communications about new monitoring protocols
• Set up patient hotline and enhanced adverse event reporting
• Prepare for accelerated earnings call (move up timeline if necessary)

Reasoning: Once we start enhanced warnings, we're committed to full transparency within 30 days maximum.

My Recommendation to the Board:

Immediate enhanced warnings + 30-day full disclosure timeline

1. Patient Safety First: Implement enhanced liver monitoring protocols immediately for all patients
2. Accelerated Investigation: 30-day deep dive with independent experts, not 6 months
3. Controlled Disclosure: Healthcare provider alerts immediately, public disclosure within 30 days
4. Financial Preparation: Reserve $500M for potential litigation, prepare market for earnings impact

Reasoning:

• Ethical: We protect patients immediately while ensuring we're not creating panic over potentially flawed data
• Legal: Demonstrates good faith effort and patient-first priority
• Financial: Controlled disclosure is better than leaked information or regulatory discovery
• Strategic: Positions company as responsible leader, not reactive follower

The board members pushing to "wait" are thinking like investors, not healthcare leaders. Our primary obligation is to the 4 million patients taking this drug daily. A 40% stock drop is recoverable; patient deaths from preventable liver failure are not.

The 72-hour earnings call timeline forces our hand—we cannot make forward-looking statements about the drug's performance without disclosing this material risk.