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Re: dmsrz8 post# 36322

Monday, 02/22/2021 3:20:50 PM

Monday, February 22, 2021 3:20:50 PM

Post# of 44692
Yep, no way of knowing. I'd have to imagine it was rather mundane reasoning and everyone who has an active trial is waiting on approval received a copy of this document prior to you and I.

However I think the more important thing to note is that we didn't change the endpoint because it was a failed trial as some would have you believe. Most likely we just received updated requirements from the FDA and updated our trial accordingly.

Does anyone keep up with other trials that would know if they changed theirs in a similar manner recently?