Do you think Q7A will affect current guidelines on biologics and biopharmaceuticals when current regulations are already ten times more stringent than anybody else’s?

It’s my understanding of the ICH process that the United States Government is a signatory to an
agreement along with the EU and the Japanese Government, which says that once ICH
documents achieve step five, none of the signatories are will have national regulations, legislation
or guidance which contravenes the ICH guidance. So to the extent that the question is a
presumption about the rigidity of U.S. regulations, it is true.