BARDA Director Robin Robinson, Ph.D., provided the following update: "It is important to keep in mind that a Stop-Work Order is not a contract termination. We have some concerns about the project with regard to the product manufacturing, clinical study enrollment pace, costs, and contractor performance. Since the project is at a natural pause following the end of the flu season for the Northern Hemisphere, we are considering what is the best next step for the Biota project and the overall influenza antiviral drug development program before going forward with clinical studies in the Southern Hemisphere and manufacturing optimization and validation."
The Company has been advised by BARDA that the final decision regarding the outcome of the IPR should be forthcoming within the next week.
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