Not all patients had 10 vaccines made from their tumor samples. The minimum required to enter the trial was 5 doses that had to be made. I believe that 7 doses is the average per patient if I recall correctly from something I read. If that is the case then late January to early February fits into the mix of timelines possible for final data to begin to be collected. Once that happens then they can choose what to do next. They can data lock all or data lock part of the number of categories for analysis accounted for in their protocols. If PFS is good enough on it's own but they still want to keep OS open for reimbursement purposes then they will data lock PFS only for now and apply for AA as they said they would using the PFS primary endpoint. I have kind of wondered if German authorities would have required PFS to be measured differently than the original trial protocols would indicate while still maintaining the original protocol basis for this determination as the basis for reporting preadjudicated trial results. Under this scenario there would be a regulator imposed comparative basis for final adjudication of all PFS event determinations. This would then be another basis utilized to help correct any treatment effect induced PFS event determinations at unblinding of PFS data. Best wishes.
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