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Dan88

04/11/21 11:23 AM

#368520 RE: iwasadiver #368514

Exactly iwasadiver. The only SAP whether it's called original or revised SAP is the SAP the sponsor uses to analyze UNBLINDED data. So in essence, there is only one SAP which is the one used in analyzing unblinded data. Or one can call other previous ones draft SAP.
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anders2211

04/11/21 11:54 AM

#368529 RE: iwasadiver #368514

NWBO finalized and drawn up 2 SAPs the recent one to which against they will unblind the data and the first one when they started the trial. Both were submitted to the FDA. You cant start a medical trial without a SAP. Thats 2. 1+1=2