Regulatory roulette at the FDA.

Regulatory roulette at the FDA. “In context, this looks like the regulatory rules of the game are being changed retroactively.” Moderna ran a 43,000 person Phase 3 trial based on FDA guidance, then got hit with a rare Refusal-to-File letter anyway, and now says it will stop funding new Phase 3 vaccine trials for infectious diseases. Crazy FDA antics. But also, Moderna saying they can’t make money on vaccines without the US market seems like an unreasonable situation. ~ learn more