hyperopia,
Not shared yet to my knowledge but as you know I have highly suspected that the SAP for L will help greatly speed up trials in the future and that requires buy in from regulators. I believe what you posted hints at this strongly and that unblinded data correlations will support this concept. Endpoints should be tied to the correlation of biomarkers to immune response and immune response to tumor stability, rate of necrosis, regression, complete response rate and potentially the induction of key memory cell markers. Endpoints should also be tied to patient health score as many will feel better when taking this treatment vs something else. OS and PFS can also be looked at but recovery and lack of events would mean looking at an acceptable cutoff point for non eventing instead of a look after x number of events. For example, if the median historical OS is 7 months for a group of patients and 85% of all patients treated are alive at 7 months then that might meet the agreed upon trial endpoint and the approval process would continue from there while data continued to mature for reimbursement and comparison to competition. Best wishes.
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