Although common themes permeate the environment across continents and particular divergences as to how to proceed exist between different regulatory agencies, it seems that policies are still in flux. Not all policies will suffice to fit all dissimilar biologics, and these in place or being developed may, in turn, change to accommodate new or unexpected developments. Consideration for accelerated approval for those compounds that do not present complex questions should be considered.The regulatory agencies should be more forthcoming, the industry sector exercise social responsibility, and the public should have realistic expectations.