Your point (5) is particularly important. They would not have locked the data until this occurred. I believe they bought into the SAP. I’m only wondering if they’re speaking regarding whether they could seek a BLA for rGBM while using this trial. That’s the only reason I have to think maybe there’s some waiting involved on this particular issue, which would be huge and would be in addition to already accepting the SAP. Thoughts?
(5) NWBio said that they would not unblind the data & let the statisticians start the process of reviewing & analyzing the data until they got buy-in on the SAP from all 4 RAs.
No, NWBO did not say "until they got buy-in from all 4 RA's"
what t hey actually said in YOUR quote from NWBO was: "as soon as the SAP process is completed ...." they do not say "buy-in" - they do say "SAP process." perhaps even if that process ends without a buy-in from all 4 RAs.