Toxicology

An investor once asked a founder a simple question: “What happens if FDA disagrees with your pathway?” The room went quiet. Not because the answer was confidential. Because there was no answer. The deal didn’t collapse immediately. But it never recovered.

An investor once said: “We didn’t pass on the company because the product was weak.We passed because we couldn’t tell if it would ever reach the […]

Two startups hit major problems at the same time. One had a technical failure—the device didn’t perform as expected. The other had a regulatory issue—the FDA questioned their pathway and evidence.

The acquisition was almost done. Term sheet agreed. Due diligence complete. Press release draft ready. Then one issue surfaced: “Regulatory alignment needs clarification.”