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Steady_T

11/05/22 5:47 PM

#381757 RE: Jonjones325 #381746

Trials are conducted with generally accepted standards. It is my belief, founded on very little actual evidence, that the trial design was approved by the FDA.

If the trial design was approved by the TGA the design would look very much the same. As for the regulatory oversight the CRO is the agent actually conducting the trials. It is the CRO and the associated facilities that are subject to the local regulatory oversight.

True about no AD sites in the US.