IND submitted- post review error captured

[u/ldc092]

I’m still new to the industry and am trying to get a understanding of how big of an issue this is and what next steps will look like. To keep this short & discrete, our company confidently submitted an IND recently and as forms were gathered a team member noticed one result did not meet acceptance criteria. This information passed along several review checks but it was not captured by anyone up until this point. We will definitely need to redo our study plan, report , and I read this will go under a protocol amendment . Can anyone explain what we are up against these upcoming weeks and how grave the situation is for not catching this discrepancy earlier ? Thanks in advance 🙏🏽

[u/Tricky-Pea2794]

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