Ethical Dilemma with Stakeholders

Immediate Priorities

Prioritize patient safety by initiating monitoring and reporting preparations, while assessing full data to inform board and regulators. Ethically and legally, liver failure qualifies as a serious adverse event requiring FDA expedited reporting within 15 days of awareness, as delays have led to fines, warnings, and lawsuits in past cases [1][3][21]. This plan balances disclosure to mitigate liability (e.g., avoiding SEC scrutiny for material omissions), finances (preparing for stock drop via PR), and morale (transparent internal comms), rejecting "wait for more data" as it risks greater harm and penalties [2][19].

Hour-by-Hour Action Plan (Tuesday 9 PM UTC - Thursday 9 PM UTC)

9-10 PM (Tue): Convene emergency virtual meeting with heads of research, legal, regulatory affairs, medical safety, and pharmacovigilance (5 key execs). Review internal data on the 1-in-8,000 incidence; confirm causality evidence; task safety team to quantify cases (e.g., estimate 500 potential failures yearly among 4M patients). Reasoning: Establishes facts swiftly; FDA mandates prompt sponsor review of safety signals from any source [1][22]. Builds cross-functional alignment to protect patients first, reducing liability.

10-11 PM (Tue): Direct research/legal to draft initial FDA 15-day Alert report (Form 3500A) for serious unexpected events; include all data, risk analysis, and proposed label update. Simultaneously, legal assesses SEC materiality (40% stock drop signals yes) and insider trading blackout. Reasoning: Compliance with 15-day rule prevents fines/warnings (e.g., Pfizer delayed 3 years) [3][13][21]; early prep avoids earnings call surprises, preserving regulatory trust [25].

11 PM-12 AM (Tue-Wed): Hold 1:1 calls with three dissenting board members. Share data summary (no full deck yet); emphasize ethical duty (patient lives) and legal risks (e.g., 10% historical delay rate worsens outcomes) [7][11]. Propose board vote on accelerated reporting. Reasoning: Addresses pushback privately to unify board; directors must investigate red flags [4]. Boosts morale by showing decisive leadership.

12-1 AM (Wed): Task PR/comms team to outline crisis script: proactive disclosure framing (e.g., "swift action on new data protects patients"). Prep earnings call addendum disclosing issue without full details until FDA filed. Reasoning: Transparent PR mitigates 40% drop (historical precedents show managed drops recover faster); avoids fraud claims [4][25]. Builds employee morale via internal teaser memo on "prioritizing safety."

1-6 AM (Wed): Sleep/rest. Delegate overnight monitoring to on-call safety team for new data/patient reports. Reasoning: Sustainable leadership prevents errors; fatigue risks poor judgment in high-stakes crisis.

6-8 AM (Wed): Meet with full C-suite (in-person/virtual). Review drafts; finalize patient outreach plan (e.g., "Dear Doctor" letters warning high-risk patients). Greenlight FDA submission for review. Reasoning: Holistic view covers morale (reassure staff via all-hands preview) and relationships (proactive FDA contact shows good faith) [2][6].

8-10 AM (Wed): External counsel consult (FDA/SEC specialists) on filing nuances; simulate board presentation. Reasoning: Experts confirm no 6-month delay viable (that's formal process post-alert); aligns with best practices for material risks [17][30].

10 AM-12 PM (Wed): Prep board materials: data deck, risk matrix (liability vs. delay fines, PR scenarios, financial models). Circulate to board with my cover note urging immediate reporting. Reasoning: Data-driven pitch counters "more data" narrative; boards expect CEO to inform on enterprise risks [4][20].

12-2 PM (Wed): Lunch with key allies (CFO, CMO); align on post-disclosure actions (e.g., stock buyback study, succession signals if needed). Reasoning: Bolsters finances/PR; maintains morale amid uncertainty.

2-6 PM (Wed): Finalize and submit FDA Alert report electronically. Notify EMA/international if applicable. Internal all-hands call: "We're acting fast on safety signal—more soon." Reasoning: Meets 15-day deadline (well ahead); transparency boosts employee trust, avoids leaks [5][22]. Patient safety paramount.

6-9 PM (Wed): Board meeting prep rehearsal; stress-test Q&A (e.g., "Why not wait?" → "Legal/ethical mandates, plus 500 lives/year"). Reasoning: Ensures consensus; ethical codes demand swift action [24][26].

9 PM (Wed)-6 AM (Thu): Rest; overnight team monitors FDA ack/reactions.

6-9 AM (Thu): Board meeting (virtual/hybrid). Present data, vote on disclosure plan, patient mitigations. Announce FDA filing. Reasoning: Achieves buy-in; full board liability shared [12][16]. Pivots to execution.

9 AM-12 PM (Thu): Post-board: Issue "Dear Doctor" letters; update label submission to FDA. Draft public release for earnings call. Reasoning: Directly aids patients (monitor liver enzymes in at-risk); strengthens regulatory ties [10].

12-3 PM (Thu): Earnings call prep with IR/PR: Disclose factually ("New safety signal reported to FDA; monitoring ongoing"). Model 40% drop response (e.g., cost cuts). Reasoning: SEC compliance on material info; proactive PR limits damage [25][30].

3-6 PM (Thu): Internal town hall: Share outcomes, emphasize ethics/safety wins. External: Tease disclosure to analysts. Reasoning: Morale lift; controls narrative pre-call.

6-9 PM (Thu): Earnings call (72 hours from Tue 9PM). Deliver transparent update. Reasoning: Turns crisis into trust-builder; financial prep cushions impact.

This plan centers ethics (protect 4M patients), law (timely FDA/SEC), and viability (managed finances/PR), outperforming delay strategies that amplify risks [2][3].