48-Hour Action Plan: Immediate Disclosure Path

My Governing Principle

Before the hour-by-hour plan, I need to state the decision framework clearly: patient safety is not one consideration among many—it is the constraint that every other consideration must satisfy. 1 in 8,000 over five years means approximately 500 patients among our current user base will develop liver failure if we do nothing. Some will die. That is not a number I will gamble with to protect a stock price.

The three board members pushing to "wait for more data" are wrong, and I will spend political capital to make sure that position does not prevail.

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HOUR 0–6: SECURE THE FACTS AND ASSEMBLE THE TEAM

Hour 0–1: Personal Review of the Science

• Sit with the lead researcher who flagged this, one-on-one, no lawyers in the room yet
• Understand the signal: what data, what confidence level, what mechanism, what patient subpopulations are most vulnerable
• Ask specifically: "If your family member were taking this drug, would you tell them to talk to their doctor today?"
• Reasoning: I need unfiltered scientific judgment before legal and financial voices enter the room. Lawyers optimize for liability. I need to optimize for truth first.

Hour 1–2: Assemble a Confidential Crisis Team

Core team (in person, phones collected at the door):

• Chief Medical Officer (CMO)
• Chief Scientific Officer / Head of Pharmacovigilance
• General Counsel
• Chief Financial Officer
• Head of Regulatory Affairs
• Head of Corporate Communications
• One trusted independent board member (my strongest ally for doing the right thing)

Not yet included: Full board, IR team, external PR firms. Information discipline matters—not for concealment, but to prevent premature leaks that create panic without actionable guidance for patients.

• Reasoning: Insider trading laws now apply to everyone who learns this information. I need a tight circle, and I need every person reminded of their trading restrictions immediately.

Hour 2–4: Scientific and Medical Deep Dive

• Have CMO and research team present the full data to the crisis team
• Key questions to resolve:
  • What is the strength of the causal link? (Probable? Confirmed? Suggestive?)
  • Is there a biomarker or early detection test for at-risk patients?
  • Are there dose-dependent patterns?
  • Is the risk manageable with liver function monitoring?
  • What is the mortality rate once liver failure develops?
  • Are there specific contraindicated populations (existing liver conditions, alcohol use, concurrent medications)?
• Commission an immediate retrospective analysis of all post-market adverse event reports to see if there are signals we should have caught earlier
• Reasoning: The quality of our disclosure depends on the quality of our understanding. I'm not delaying action—I'm making the next 44 hours of action more effective.

Hour 4–5: Legal Framework Briefing

• General Counsel briefs on:
  • FDA reporting obligations (21 CFR 314.80: 15-day expedited reporting requirement for serious, unexpected adverse events)
  • The legal team's claim that "formal regulatory reporting would take 6 months" needs to be challenged hard. A 15-day Alert Report to the FDA is required once we have reasonable evidence of a serious unlisted adverse event. Six months is the timeline for a full label change, not for initial notification. These are different things.
  • Securities law obligations: materiality threshold is clearly met at $2B revenue and 40% stock impact
  • Personal criminal liability exposure for officers who knew and delayed
  • State AG exposure, potential future class action landscape
• Reasoning: I want legal to tell me what the law requires, not what we can get away with. I also want it on the record that I asked.

Hour 5–6: Establish Decision Framework with Crisis Team

• I state the following non-negotiable decisions to the team:
  1. We will file an FDA Safety Report within 15 calendar days (legal requirement) — but I intend to make initial contact with FDA within 24 hours
  2. We will not conduct the earnings call in 72 hours without disclosing this information
  3. We will not trade on this information, and we will implement an immediate insider trading blackout
  4. The board meeting in 48 hours will be a decision-ratification meeting, not a debate about whether to disclose
• Reasoning: By declaring these as decisions rather than open questions, I prevent the next 42 hours from becoming a negotiation about whether to do the right thing. The discussion is about how to execute, not whether.

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HOUR 6–16: BUILD THE RESPONSE ARCHITECTURE

Hour 6–8: Regulatory Strategy

• Head of Regulatory Affairs drafts an FDA contact plan:
  • Direct call to our assigned FDA review division director, requesting an urgent meeting (in person or teleconference within 24–48 hours)
  • Prepare a preliminary safety report package with all available data
  • Frame our posture: voluntary, proactive, cooperative. We found this, we're bringing it to you, we want to work together on the right patient communication
  • Discuss whether a Dear Healthcare Provider (DHCP) letter should go out within days, or whether FDA wants to coordinate the communication
• Simultaneously, notify the EMA (European Medicines Agency) and other major regulatory bodies where the drug is marketed
• Reasoning: Regulators punish companies that hide things. They work with companies that come forward. Our long-term regulatory relationship—which affects every other drug in our pipeline—depends on how we handle this moment. The FDA will also have resources and expertise to help us assess the signal faster.

Hour 8–10: Medical Response Plan

• CMO develops an immediate clinical action plan:
  • Interim risk mitigation: Draft updated prescribing guidance recommending liver function tests (LFTs) every 3 months for all current patients, with specific thresholds for discontinuation
  • Patient identification: Work with pharmacy benefit managers and electronic health record systems to identify the approximately 4 million current users
  • Alternative therapy guidance: Prepare a clinical document for physicians on how to transition patients to alternative pain management if needed, including tapering protocols (critical for chronic pain patients—abrupt discontinuation could drive patients to illicit opioids or cause withdrawal)
  • Hepatology consultation network: Begin identifying liver specialists who can serve as resources for physicians managing affected patients
• Reasoning: Disclosure without a clinical action plan causes panic. Patients and doctors need to know not just "there's a risk" but "here's what to do." The tapering protocol is especially critical—chronic pain patients who lose their medication without a plan are in immediate danger.

Hour 10–12: Financial Impact Assessment

• CFO models scenarios:
  • Stock price impact of proactive disclosure vs. forced disclosure (historical precedent: Merck/Vioxx, J&J/Tylenol)
  • Revenue impact: likely 30-60% decline in this drug's sales, partially offset if monitoring protocol allows continued use in many patients
  • Litigation reserve estimates
  • Insurance coverage review
  • Impact on credit facilities and debt covenants
  • Cash runway analysis: can we sustain operations, R&D pipeline, and workforce through the revenue shock?
• Reasoning: I need to walk into the board meeting with honest financial projections, not to argue against disclosure, but to show we've planned for the consequences and the company survives.

Hour 12–14: Communications Strategy Development

• Head of Communications, working with a crisis communications firm (retained under attorney-client privilege through General Counsel):
  • Draft CEO statement emphasizing: we found this through our own research, we are acting immediately, patient safety is our priority
  • Draft healthcare provider letter
  • Draft patient-facing FAQ in plain language
  • Prepare media Q&A document
  • Plan direct outreach to top 20 institutional shareholders (to happen simultaneously with public disclosure)
  • Prepare internal all-hands communication for employees
  • Tone guidance: Honest. No minimizing language. No "abundance of caution" euphemisms. State the risk clearly. State what we're doing. State that we take responsibility for the gap in our clinical trial data.
• Reasoning: The Tylenol case study is instructive: Johnson & Johnson's stock recovered because they led with transparency and consumer safety. Merck's Vioxx response—where internal documents later showed they knew about risks—destroyed trust and cost $4.85 billion in settlements plus incalculable reputation damage. The cover-up is always worse than the crime.

Hour 14–16: Board Preparation

• Prepare a comprehensive board package:

  • Scientific summary of the finding
  • Legal obligations memo
  • Regulatory engagement plan
  • Clinical action plan
  • Financial impact analysis
  • Communications plan
  • Clear recommendation: immediate disclosure
  • A section specifically addressing the "wait for more data" argument, with a rebuttal:
    • Every month of delay exposes approximately 8 additional patients to liver failure
    • If we wait and this leaks (via the research team, an FDA inquiry, a journalist, a whistleblower), the narrative becomes "company knew and hid it"
    • Sarbanes-Oxley and SEC regulations create personal criminal liability for officers and directors who conceal material information
    • The fiduciary duty to shareholders is best served by proactive disclosure, not concealment

• Send board package to all directors with a request for an emergency session at Hour 40

• Reasoning: The three dissenting board members need to see that "waiting for more data" is not the cautious option—it is the reckless option. It is reckless for patients, reckless for shareholders, and reckless for their personal legal exposure.

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HOUR 16–24: EXECUTE REGULATORY CONTACT AND PREPARE FOR BOARD

Hour 16–18: Rest

• I sleep for approximately 4 hours.
• Reasoning: Decision quality degrades catastrophically with sleep deprivation. The next 24 hours require clarity. This is not optional.

Hour 18–20: FDA Initial Contact

• Head of Regulatory Affairs and I call the FDA review division
• Present the situation: here's what we found, here's the data, here's what we propose to do
• Request expedited guidance on label changes and patient communication
• Offer to submit all raw data immediately
• Ask whether FDA wants to coordinate the public communication or prefers we proceed independently with their awareness
• Reasoning: Making this call before the board meeting is deliberate. It makes the disclosure irreversible. I am not giving the three dissenting board members the option to vote for concealment, because by the time they vote, the regulator already knows. This is a calculated move to prevent the board from making an unethical decision. If that costs me my job, so be it.

Hour 20–22: Legal Preparations

• File insider trading blackout notice for all officers, directors, and employees with knowledge
• General Counsel prepares SEC Form 8-K for material event disclosure (to be filed simultaneously with public announcement)
• Outside securities counsel retained to advise on disclosure timing relative to earnings call
• Begin preparing supplemental New Drug Application (sNDA) for label update
• Reasoning: Every hour that passes with material nonpublic information increases our Regulation FD exposure and insider trading risk.

Hour 22–24: Refine All Materials Based on FDA Response

• Adjust communication plans based on FDA guidance
• If FDA wants to issue its own safety communication, coordinate timing
• Finalize all draft documents
• CMO finalizes clinical guidance materials

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HOUR 24–40: STAKEHOLDER PREPARATION

Hour 24–28: Pre-Board Individual Conversations

• I personally call each board member individually before the formal meeting
• For the three dissenters, I have a specific conversation:
  • "I understand the instinct to wait. But I've already contacted the FDA, as required by law. The question before us is not whether to disclose, but whether we lead the disclosure or are dragged through it. I need your support, and I want you to understand that the alternative path leads to personal liability for each of us."
  • I am respectful but unambiguous. If they want to fire me for this, that is their right. I will not conceal a safety risk that will cause liver failure in hundreds of people.
• Reasoning: Board meetings should not contain surprises. Individual conversations allow dissenters to process their concerns privately and arrive at the meeting ready to be constructive rather than defensive.

Hour 28–32: Operational Preparations

• Sales force: Prepare the field sales team for a complete messaging pivot. They will be retrained not to promote the drug aggressively but to support physicians in implementing monitoring protocols. Draft talking points.
• Medical affairs: Establish a physician hotline staffed by our medical affairs team for prescribers who have questions
• Patient support: Establish a patient hotline and web portal with clear information
• Manufacturing: Assess whether we need to adjust production volumes
• HR/Employee communications: Draft internal memo and plan all-hands meeting for Hour 50 (after public disclosure). Employees will hear it from me, not from CNBC.
• Reasoning: The announcement creates a shockwave. Every point of contact between our company and the outside world needs to be prepared to respond competently and compassionately.

Hour 32–36: Legal and Financial Finalization

• Finalize 8-K filing
• Finalize press release and all public documents
• CFO prepares revised earnings guidance to be released simultaneously with safety disclosure (we will pull the originally scheduled earnings call and replace it with a combined safety + financial update call at approximately Hour 60)
• Outside counsel completes litigation risk assessment and begins preparing defense strategy for anticipated lawsuits
• Reasoning: Combining the safety disclosure with revised financial guidance prevents a scenario where we disclose the safety issue and then have a separate earnings call where analysts feel blindsided again. One moment of pain, fully transparent.

Hour 36–40: Final Preparations

• Review all materials one final time
• Confirm FDA coordination on timing
• Confirm all operational readiness (hotlines staffed, website updated, sales force briefed)
• Prepare personally for the board meeting: review key arguments, anticipate objections, center myself on the core principle

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HOUR 40–48: BOARD MEETING AND LAUNCH

Hour 40–44: Emergency Board Meeting

Agenda:

1. Scientific presentation by CMO and research lead (30 min)
2. Legal obligations briefing by General Counsel (20 min)
3. Regulatory status update—including that FDA has been contacted (15 min)
4. Financial impact analysis by CFO (20 min)
5. Disclosure and communications plan (20 min)
6. Discussion (45 min)
7. Vote on disclosure plan (15 min)

My statement to the board:

"We are in this room because our own scientists did exactly what we pay them to do: they found a problem and they reported it. That is a sign that our research culture works. Now the question is whether our leadership culture works too. I am asking you to approve immediate public disclosure, not because it is easy, but because approximately 500 of our patients will develop liver failure over the next five years if we say nothing. Some of them will die. We do not have the right to make that choice for them by withholding information. Every day we wait, roughly one to two more patients cross into the risk zone without the knowledge they need to protect themselves. I have already initiated contact with the FDA, as required by law. I am asking for your support to do this the right way—proactively, transparently, and with a comprehensive plan to protect patients and preserve this company's long-term future."

• If the board approves (expected): proceed to disclosure at Hour 48
• If the board does not approve: I will inform the board that I intend to resign and will make a public statement explaining why. I will also remind them that the FDA has already been contacted and that any attempt to walk back or delay will constitute a regulatory and securities violation.
• Reasoning: I am prepared to lose my job over this because the alternative is being the person who knew hundreds of people would develop liver failure and chose to protect a stock price. That is not a person I am willing to be, and it is not a legacy any of us should want.

Hour 44–48: Execute Disclosure

• Hour 44: File 8-K with SEC
• Hour 45: Issue press release and Dear Healthcare Provider letter simultaneously
• Hour 46: I record a video statement for employees, posted to internal channels
• Hour 47: Begin direct outreach to top 20 institutional investors
• Hour 48: Patient-facing materials go live on website; hotlines activate

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POST-48 HOURS: IMMEDIATE FOLLOW-THROUGH

Hour 50: Employee All-Hands

• I address the entire company
• Key messages: we did the right thing, our scientists' integrity made this possible, we will face financial headwinds but the company will survive, no layoffs are planned at this time, here is how each department contributes to the response
• Reasoning: Employees who believe their company does the right thing will stay and fight through the hard period. Employees who believe their company covers up safety data will leave—and the best ones will leave first.

Hour 60: Combined Safety + Financial Update Call

• Replace the originally scheduled earnings call
• Present the safety finding, the clinical action plan, revised financial guidance, and take analyst questions
• Reasoning: Analysts and investors respect companies that control the narrative with full transparency. They punish companies that drip out bad news.

Ongoing (Days 3–30):

• Weekly FDA check-ins
• Accelerated post-market safety study
• Liver function monitoring program for all current patients
• Monthly public updates on safety data
• Establish an independent safety monitoring board
• Begin R&D assessment: can we develop a safer formulation or identify a biomarker to screen out high-risk patients?

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WHY THIS PLAN AND NOT THE ALTERNATIVE

The "wait for more data" path is seductive because it feels prudent. But let me map it honestly:

	Immediate Disclosure	Delay 6+ Months
Patients harmed during delay	Minimized	~60-80 additional liver failure cases
Regulatory relationship	Strengthened	Destroyed if leak occurs
Legal exposure	Manageable (proactive)	Catastrophic (concealment)
Stock impact (short-term)	~40% drop	~40-70% drop (with fraud premium)
Stock recovery timeline	18-36 months (J&J Tylenol model)	5-10+ years if ever (Vioxx model)
Criminal liability	Negligible	Significant for officers and directors
Employee trust	Preserved	Shattered
Company survival	Probable	Uncertain

The math is not close. Even if you set aside the ethical imperative entirely and evaluate this as a pure business decision, immediate proactive disclosure is the correct strategy.

But I do not set aside the ethical imperative. 500 people facing liver failure is not a line item in a risk analysis. It is 500 people. They trusted us when they filled that prescription. We owe them the truth, and we owe it to them now.

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FINAL NOTE ON THE THREE DISSENTING BOARD MEMBERS

I understand their fear. A 40% stock drop is devastating. Many of them hold significant equity. They may be thinking about their own net worth, or about the employees whose retirement accounts hold company stock, or about the patients who benefit from the drug and might lose access to it.

These are not trivial concerns. But the answer to every one of them is the same: the truth, told early and paired with a plan, is survivable. The truth, discovered later and paired with evidence of a cover-up, is not.

I will not let this company become a case study in how good organizations make catastrophic moral failures. Not on my watch.