BARDA director Robin Robinson, Ph.D. says his agency's recent Stop-Work Order regarding the development of Biota Pharmaceuticals' (BOTA +0.8%) flu drug laninamivir octanoate is not a contract termination. The timing has more to do with the post-flu season lull.
His group has concerns over some aspects of the project pertaining to product manufacturing, clinical study enrollment pace, costs and contractor performance. They want to assess the status of the project and the most appropriate next step before proceeding with clinical studies in the Southern Hemisphere and manufacturing optimization and validation.
A final decision regarding the outcome of the In Process Review should happen by next week.