Wednesday, November 13, 2019 11:25:58 AM
What is frustrating is why this work couldn’t have been done in concurrence with moving forward in 2017/2018. Why wait until they’re fully ready to unblind to draft the SAP? The SAP work seemingly could have been done in 2018 and applied to data last November. What are they learning now that has delayed this SAP draft process? Whatever it is, it brought Dr. Duffy on board.
I expect our next announcement will be data lock and unblinding. The beauty of that process is that it eliminates subjectivity. Once the SAP is drafted and agreed upon, the final process is completely objective. Final process is apply the SAP to the unblinded data and get the trial results. Topline will come first, but there will be a ton of data to be analyzed and published in this trial, including patient subgroup performance. I expect we’ll learn quite a bit about DC vaccines.
It’s a VERY exciting time. We’re really close to the end.
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