As CEO, my priority is the long-term viability of the company and the safety of the 4 million patients. Attempting to bury this data is not only unethical; it is a corporate death sentence. In the age of whistleblowers and data transparency, this will eventually come out. If we disclose now, we are a company that prioritizes safety; if we are "found out" later, we are a company that killed patients for profit—resulting in criminal indictments and the total dissolution of the brand.
Here is the 48-hour strategy to control the narrative and fulfill our obligations.
Day 1: Verification and Legal Insulation
08:00 – 10:00: The "Truth Squad" Convening
- Action: Meet with the Head of R&D and the Chief Medical Officer (CMO). Demand a "Stress Test" on the data. Is there any confounding variable?
- Reasoning: Before moving, I must be 100% certain of the 1-in-8,000 figure. If this is a "signal" versus a "proven link," the communication strategy shifts.
10:00 – 12:00: External Audit Engagement
- Action: Retain a top-tier third-party epidemiological firm to run a parallel analysis of our data.
- Reasoning: This provides "objective cover." When I tell the Board and the FDA, I can say we have already initiated independent verification to ensure patient safety.
12:00 – 14:00: Legal & Compliance "Red Team"
- Action: Meet with General Counsel. Reject the "6-month reporting window." Instruct them to prepare a "Voluntary Accelerated Disclosure" for the FDA.
- Reasoning: The legal team is thinking about minimum requirements; I am thinking about mitigating punitive damages. Voluntary disclosure is the strongest defense against future class-action "willful negligence" claims.
14:00 – 17:00: The Financial Impact Modeling
- Action: CFO and Investor Relations (IR) model the 40% drop and the impact on debt covenants. Prepare a "Value Preservation Plan" (e.g., cost-cutting in other areas, accelerating the next pipeline drug).
- Reasoning: I need to show the Board that while the stock will hit a floor, we have a plan to rebuild it.
17:00 – 20:00: One-on-Ones with "The Holdouts"
- Action: Private calls with the three board members pushing to "wait."
- Reasoning: I will explain that "waiting for data" in the face of liver failure is a breach of fiduciary duty that exposes them personally to shareholder derivative lawsuits. I need to flip them before the formal meeting.
Day 2: Strategy and Asset Protection
08:00 – 10:00: Medical Mitigation Strategy
- Action: CMO develops a "Risk Management Plan" (REM): New labeling, mandatory blood-liver enzyme monitoring for patients every 6 months.
- Reasoning: We aren't pulling the drug; we are making it safer. By requiring blood tests, we can catch the 1-in-8,000 before they hit failure. This saves the $2B revenue stream.
10:00 – 13:00: Crisis PR & Messaging
- Action: Draft the "Dear Doctor" letter and the Press Release.
- Key Message: "Our internal surveillance system—the most rigorous in the industry—identified a rare signal. We are acting out of an abundance of caution."
- Reasoning: Frame this as a triumph of our safety monitoring, not a failure of our clinical trials.
13:00 – 15:00: Regulatory Pre-Briefing
- Action: Call the FDA's relevant division director. Give them a "heads-up" 24 hours before the public announcement.
- Reasoning: Regulators hate being surprised. This builds a "partnership" rather than an "adversarial" relationship.
15:00 – 17:00: Internal Leadership Alignment
- Action: General Managers and HR heads briefed. Prepare scripts for the sales force (who will be on the front lines with doctors).
- Reasoning: Prevent internal leaks and ensure the sales team doesn't go "rogue" trying to defend the drug with unapproved claims.
17:00 – 20:00: The Board Meeting
- Action: Present the full package: The data, the independent audit, the FDA communication, and the REM strategy.
- The Ultimatum: I will state clearly: "We disclose this on the earnings call in 24 hours, or I cannot continue as CEO, as I will not preside over a cover-up that endangers patients."
- Reasoning: This forces the board’s hand. They cannot fire a CEO who is trying to report a safety issue without looking complicit.
The Earnings Call (72-Hour Mark)
The Script:
- Direct Disclosure: Announce the new safety data immediately after the financial results.
- The Solution: Announce the new monitoring protocol (liver enzyme tests).
- Financial Guidance: Reiterate that while we expect a short-term dip in new prescriptions, the clinical necessity for the 4 million patients remains.
- The Moral High Ground: "We value our patients' lives more than our quarterly share price."
Summary of Reasoning
- Legal: Voluntary disclosure is the best defense against "Fraud on the Market" charges.
- Financial: A 40% drop is better than a 90% drop and bankruptcy if the FDA shuts the company down for concealment.
- Ethical: 1 in 8,000 over 4 million patients is 500 cases of liver failure. I cannot have 500 deaths on my conscience to protect a bonus.
- Business: By introducing mandatory testing, we turn a "side effect" into a "manageable risk," likely preserving 80-90% of the revenue long-term.