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Horseb4CarT

05/19/22 1:03 AM

#475857 RE: DavidW2 #475854

Davidw2, the working assumption is yes for the following reasons:

1) nwbo stated one and only SAP for all

2) statistical analyses per the SAP

3) would not data lock if SAP not set

4) UK & EU endpoints updated by govts

5) given 1-4, FDA didn’t object=tacit approval