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Re: j e d post# 366172

Thursday, 04/01/2021 3:21:52 AM

Thursday, April 01, 2021 3:21:52 AM

Post# of 828262
So is your argument that 1) they have not received buy in from all their relevant RA’s; or is it 2) that they proceeded without the buy in, despite saying that they would not, and never told us otherwise?

This description of the relevant statements and events seems accurate to me as per my best recollection, and quotes other posters here, and was created by another poster here. It seems like we have a number of people who recall similar circumstances and statements that are consistent with also the nature of the regulatory practice as we understand it with regard to a single, global trial. It is u likely that different agencies will have fundamentally different SAP’s and measures applying to the same trial. There may be some differences around the edges, but it seems unlikely that it would make sense for them to coordinate on such sorts of approvals and then, for the same exact trial, diverge in basic measures by jurisdiction, particularly given the many regulations they have put into place to avoid those kinds of conflicts and different standards.

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