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01/21/22 6:10 PM

#437606 RE: iwasadiver #437587

The only requirement is that the SAP be completed before unblinding.

The only requirement is that the SAP be completed before unblinding.

The only requirement is that the SAP be completed before unblinding.

The only requirement is that the SAP be completed before unblinding.

The only requirement is that the SAP be completed before unblinding.

The only requirement is that the SAP be completed before unblinding.


Exactly!

The protocol was changed many various times... at least 4 times that I'm aware of (and have copies of). They had removed an entire arm (the pseudoprogression arm) by the 6th version, that had been in the 4th one.

And there is almost certainly a new protocol now... with the new endpoints. Perhaps another medical center will accidentally leak it again (Cleveland leaked the last one), lol.

But the SAP is an entirely separate document... and LP et al did not ever submit one until they did in 2021. And without it, they couldn't have done an IA; at least according to the protocol.