At Bonaventure Equity, we aim to bring you perspectives from the front lines of investing in controlled substances, delving beyond the headlines in this dynamic field.
This week, we are pleased to invite this guest perspective from Alysia A. Bullock.
Navigating the trough: Turning FDA setbacks into leadership wins
Lykos Therapeutics recently faced a significant hurdle when the FDA issued a Complete Response Letter (CRL), indicating that while their review was complete, certain issues needed to be addressed before approval could be granted. This event is symbolic of the “trough of disillusionment” phase in the Gartner Hype Cycle, where initial optimism and high expectations are tempered by the practical realities of regulatory scrutiny and development challenges.
There is significant hype surrounding the potential to break new ground in psychedelic regulations. However, shortly after the CRL was issued, the company leadership announced a significant reduction in force. This shift in momentum set the stage for critical leadership moments in navigating challenging news.
Keep it real
Leadership during tough times requires transparency.
After the FDA’s response, the company announced major headcount reductions. Leaders must prepare their organizations for all possible outcomes, including regulatory setbacks. Despite the most thoughtful planning, tough news can still be uncomfortable to share. However, communicating decisions with honesty, clarity, and empathy will always prevail, while safeguarding the company’s reputation.
Learn together
Leadership resilience isn’t just about navigating through setbacks but learning from them as a team.
Setbacks can be costly in terms of time, resources, employee engagement, and momentum. Yet, they can also be reframed as opportunities for learning and improvement. Leaders who encourage iterative learning create a culture where employees feel safe to try, fail, learn, and try again. In this environment, teams can reflect on prior decisions, take different actions, and evolve in how they move forward. Conversely, a culture of blame and finger-pointing fosters fear, stifles creativity, and hampers decision-making and productivity.
Stay the course
In uncertain times, a clear and compelling vision provides both direction and stability.
A company’s vision serves as both an anchor for direction and a compass for decision-making. In good times, a strong, compelling vision provides clarity on why a company exists — its purpose — and motivates employees. During turbulent times, that same vision helps employees understand the rationale behind decisions and changes. This clarity, along with transparent communication from leadership, reduces uncertainty and confusion, making it easier for employees to adapt and stay resilient.
Go deeper
Read our BVE Insights article about this news: FDA rejects Lykos MDMA study: Why we support this decision
And join us for our September 4 2024 webinar FDA & The Collapse of Lykos | The Opportunity for Psychedelics where we’ll explore this news and more.
