FDA and Infant Bacterial Therapeutics agree on the design of Phase III study

FDA and Infant Bacterial Therapeutics agree on the design of Phase III study

Source: 
CP Wire
snippet: 

For an extended time, IBT has consulted with the US Food and Drug Administration (FDA) on how the company’s planned Phase III study should be designed. IBT announced on 5/19/19 that the FDA has now informed IBT in writing that IBT has responded satisfactorily to the comments that the FDA had regarding the study design and that there are currently no additions from the FDA’s side.