The litmus test for any drug is the efficacy data

The litmus test for any drug is the efficacy data of a well designed double blind placebo controlled study. In an ideal world approval would be based on this data and only this data. But this is not a world of dreams and thus any approval goes though some type of political process or another each woth their own set of challenges, so more so then others. I think the U.K. approval will be much less challenging to get then the FDAs.