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Investing in situations hinging on a regulatory catalyst, like FCC approval, often involves frustrating delays. Success requires patience and using informal channels— "scuttlebutt" and reading tea leaves—to continually verify that the underlying thesis remains positive despite the slow timeline.
The Chinese bamboo parable illustrates that years of seemingly fruitless effort can build a foundation for rapid growth. The real challenge is knowing when you're building unseen roots versus wasting time on a dead end.
A significant disconnect exists between the FDA leadership's public statements promoting flexibility and the stringent, delay-prone reality faced by companies. For areas like gene therapy, firms report feeling the "rug was pulled out," suggesting investors should be skeptical of the agency's accommodating PR.
An investment thesis is a plot. The theatre rule of "Chekhov's Gun"—that a gun shown in Act 1 must fire by Act 3—is a powerful mental model. If a key catalyst for your investment doesn't materialize within your expected timeframe, the story has fundamentally changed, signaling that it may be time to exit.
While frustrating, delays in a catalyst-driven investment can be beneficial. For NextNav, the slow FCC approval process allowed time for the satellite-to-device market to emerge, significantly increasing the potential value of its spectrum beyond what was envisioned in the original thesis.
A change in leadership at the FDA can completely alter the viability of a drug's approval. Unicure's gene therapy, previously stalled under former officials Marty Makkari and Vinay Prasad, found a clear path to submission after they departed. This demonstrates that the philosophies of individual regulators, not just established processes, can dictate a drug's future.
Despite positive clinical data for its Duchenne gene therapy, REGENXBIO is delaying its FDA submission until 2027 due to leadership turmoil at the agency. This demonstrates how political and administrative uncertainty within a regulatory body can directly stall corporate timelines and delay patient access to potentially life-saving treatments.
Facing a long regulatory delay, Bobbie treated the pre-launch period as a strategic opportunity. Instead of waiting passively, they built a blog, became a thought leader, and cultivated a "founding community" that became a key asset at launch.
The story of The Slants' trademark case reveals a paradox: success requires both speed and slowness. You must rush to meet critical deadlines and gather support, but then you must exercise immense patience while waiting for institutions to respond. These two seemingly opposite skills must work in tandem.
Founders in regulated spaces shouldn't expect linear progress. The journey is a psychologically taxing "desert" with no status updates, culminating in sudden "big bang moments" of approval or rejection. This uncertainty, where years of work might yield nothing, is the primary challenge, not the work itself.
Unlike for-profit ventures driven by rapid ROI, a non-profit biotech's timeline is dictated by maximizing the chances of success. The founder is comfortable if it takes five years just to complete pre-IND submissions, as the primary goal is ensuring the drug gets approved by the FDA, not rushing to market for investors.