Bubs Australia reaches 400 infant enrollments in FDA approval study
Health
Bubs Australia (ASX:BUB) announced the enrolment of the 400th infant in its growth monitoring study.
The GMS and accompanying clinical trial aim to meet the regulatory guidelines set by the US Food and Drug Administration for permanent market access for Bubs' infant formulas in the United States.
Bubs began enrolling infants in the trial in late August 2023, completing the process within 13 months despite a competitive market landscape.
The clinical trial evaluates the growth, tolerance, and safety of Bubs' infant formulas, including goat milk and two cow milk products, alongside a commercially available formula as a control and a breast-feeding cohort.
The trial is overseen by Keith Aqua, a board-certified obstetrician and gynecologist with vast experience in clinical trials.
Aqua is co-founder of the HCA Florida Institute for Women's Health and Body and Visions Clinical Research.
"This represents a critical step towards achieving permanent market access. We are pleased to have finalised patient enrolment in a significant study involving three distinct Bubs Infant Formulas," said Richard Paine, COO of Bubs Australia.
Bubs plans to submit the completed GMS and clinical trial documentation to the FDA early in 2025, with regulatory approval expected in October 2025.
Bubs Australia is a vertically integrated producer of goat milk formula engaged in providing a range of organic baby food, goat milk infant formula products, adult goat milk powder products and fresh dairy products. It also provides canning services for nutritional dairy products.