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In reviewing that data, the fda made a determination that they would rather see true efficacy numbers an effectiveness. they may actually not just need to rely on this but look at actual cases to determine whether or not they want to move forward with an authorization or approve this request for expansion of their data. >> so is it as simple they know two doses are not cutting it and they need to make sure that they can test that three dose dozen? >> they have a lot of pushback for even approval...