I was told FDA viewed this SAP at high value with little changes that this SAP will be the standard for immunotherapy trials in the future. I was also told FDA used this SAP to draft their proposed Effectiveness Efficacy guidance under addressing the comments timeline now. Some of the biomarkers results from this DcVaxL trial when unblinded will be used as a guide to approve therapies faster based on short term PFS and OS endpoints run at chemo trial lengths to save time and money. This will all become clear once the FDA guidance is published in the federal register and of course L approval is already in the bag once published as all we have to show is improvement over SOC. We got improvement in many folds!
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