seeking a answer to a question from the more well informedIf you please, would some of the more informed posters here at the Lexaria Bioscience Corp. bulletin board provide their understanding of the reciprocal agreements amongst the FDA and the European Medicnes Agency, EMA, which would allow for existing North American based study data to be entirely transferable to and imediately eligible for applicabilty to any intended expansion of a global clinical trial study of a therepeutic treatment candidate into any of the 27 member states of the European Union.
What's more, when undertaking the phase 3 prtion of the global clinical studies within the European Union, would the suggested and approved 'confirmatory' phase 3 trial protocols, in undertaking such a global study, be solely determined by EMA authorities and should the reciprocal agreements in place amongst the FDA and the EMA allow for EMA established protocols for any confirmatory phase 3 clinic trials to be entirely acceptable to the American FDA authority?
I know there are more than a few well informed and experienced biotech investors here at the Lexaria Bioscience Corp. bulletin board.
f you could, would some of you please confirm what my understanding of the reciprocal agreement amongst the FDA and the EMA does allow for.