Bubs Australia Achieves Key Milestone with 400th Infant Enrolled in Clinical Trial

Sep 17, 2024

Bubs Australia Limited (ASX: BUB) has successfully enrolled its 400th infant in the Growth Monitoring Study (GMS), a crucial step towards gaining permanent market access in the U.S. infant formula market. The trial, which began in August 2023, is part of the regulatory process set by the U.S. FDA. It evaluates Bubs' Goat Milk and two Cow Milk formulas, along with a control and a breastfeeding cohort. Under the guidance of Dr. Keith Aqua, the trial aims to transition Bubs from 'temporary enforcement discretion' to full FDA approval by October 2025. This milestone signifies Bubs' progress in the regulatory process and its commitment to providing high-quality nutrition to American families.

 

 

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