Friday, January 21, 2022 9:26:30 AM
You realize that the SAP they submitted to regulators in 2020 ws the first one, right? There was hands down, NO SAP existing for the trial prior to that time. Yet in order to perform an efficacy analysis required an SAP. It's not that it just wasn't mistakenly leaked (by outsiders)... there wasn't one to leak.
I highly doubt there was no earlier SAP. All you have shown was that it was not done as a section of the protocol, not that none existed.
If you are relying on the "will be provided" language, ypu are grasping. The leaked protocols were from prior to an IA. And further, it also says the DMC Charter will be provided. Did they not provide the DMC charter either?
But have it your way. They still could perform an IA as they say additional stat details would be in that DMC charter.
Not ever having created the SAP only makes this trial more of a running clown act.
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