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Saturday, January 15, 2022 2:39:59 PM
When you regulate a trial, you need to know all that it entails to determine if it is something that is possible to license in a given jurisdiction. This was a Phase 3. You're honestly proposing that they only need to know what happens in Germany as a relevant regulator? They need to be privy to all that the other regulators know.
At the beginning, they likely only know what the IND was and the basis upon which the trial is approved to go forward. There is no way that they then are kept in the dark as to what the trial data involves. All the regulators know all the data and all that the other regulators know, and in the instance of a blind trial, more than the sponsor and trial managers and doctors know.
At the beginning, they likely only know what the IND was and the basis upon which the trial is approved to go forward. There is no way that they then are kept in the dark as to what the trial data involves. All the regulators know all the data and all that the other regulators know, and in the instance of a blind trial, more than the sponsor and trial managers and doctors know.
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