“Once we satisfactorily complete safety and manufacturing sections and other requirements, vets will be able to prescribe LOY-001 to extend the lifespan of large dogs while we complete the confirmatory pivotal lifespan extension study in parallel.”
Loyal filed a 2,300-page technical section and the FDA accepted that LOY-001 is likely to work. Nobody has shown it extends a single dog’s life yet. The evidence is lab dogs in an accelerated aging model and an observational study of 451 dogs that got no drug. Conditional approval lets Loyal sell for five years before it has to prove the one claim on the label.