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Re: flipper44 post# 414970

Thursday, 11/04/2021 1:18:44 PM

Thursday, November 04, 2021 1:18:44 PM

Post# of 700660
agreed. My take on the delay is that once data was locked, a new process was employed. Where in years past, the data tables and endpoints, curves, comparisons were done in a pretty standard fashion, this changed with our trial. Adding external historical comparisons slowed the process. Then, while evaluating, the SAB, Experts, peer-review, etc...were looking at a trial from a different perspective than ever before. There were likely more questions and requests, therefore, the delay. I think we are close now though. Just will be Journal timeframe now.
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