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File Name Date Produced File Size Link FDA-CBER-2021-5683-0396200-0396213_125742_S1_M5_bnt162-01-A-D-adae.zip (xpt) September 1, 2022 64 KB FDA-CBER-2021-5683-0396214-0396222_125742_S1_M5_bnt162-01-S-D-cm.zip (xpt) September 1, 2022 15 KB FDA-CBER-2021-5683-0396223-0396227_125742_S1_M5_bnt162-01-S-D-dv.zip (xpt) September 1, 2022 6 KB FDA-CBER-2021-5683-0396228-0396233_125742_S1_M5_bnt162-01-S-D-rp.zip (xpt) September 1, 2022 4 KB FDA-CBER-2021-5683-0396234-0396238_125742_S1_M5_bnt162-01-S-D-suppdv.zip (xpt) September 1, 2022 3 KB FDA-CBER-2021-5683-0396239-0396241_125742_S1_M5_bnt162-01-S-D-suppeg.zip (xpt) September 1, 2022 1 KB FDA-CBER-2021-5683-0396242-0396246_125742_S1_M5_bnt162-01-S-D-suppxa.zip (xpt) September 1, 2022 3 KB FDA-CBER-2021-5683-0396247-0396248_125742_S1_M5_bnt162-01-S-D-ta.zip (xpt) September 1, 2022 2 KB FDA-CBER-2021-5683-0396249-0396254_125742_S1_M5_bnt162-01-S-D-xb.zip (xpt) September 1, 2022 4 KB FDA-CBER-2021-5683-0396255-0484341_125742_S1_M5_c4591001-S-Supp-D-suppface.zip (xpt) September 1, 2022 11 MB FDA-CBER-2021-5683-0396199_125742_S1_M5_bnt162-01-S-D-tv.zip (xpt) August 1, 2022 1 KB FDA-CBER-2021-5683-0396198_125742_S1_M5_bnt162-01-S-D-te.zip (xpt) August 1, 2022 1 KB FDA-CBER-2021-5683-0396197_125742_S1_M5_bnt162-01-S-D-supprp.zip (xpt) August 1, 2022 1 KB FDA-CBER-2021-5683-0396196_125742_S1_M5_bnt162-01-S-D-supppe.zip (xpt) August 1, 2022 1 KB FDA-CBER-2021-5683-0396195_125742_S1_M5_bnt162-01-S-D-relrec.zip (xpt) August 1, 2022 1 KB FDA-CBER-2021-5683-0396193 to -0396194_125742_S1_M5_c4591001-S-D-supppe.zip (xpt) August 1, 2022 1.4 KB FDA-CBER-2021-5683-0396188 to -0396192_125742_S1_M5_c4591001-S-D-suppmo.zip (xpt) August 1, 2022 8.6 KB FDA-CBER-2021-5683-0396187_125742_S1_M5_c4591001-S-D-pr.zip (xpt) August 1, 2022 2.7 KB FDA-CBER-2021-5683-0308157 to -0396186_125742_S1_M5_c4591001-S-D-suppface.zip (xpt) August 1, 2022 11 MB 125742_S2_M5_54_ezeanolue-e-2019.pdf August 1, 2022 40 MB FDA-CBER-2021-5683-0296904 to -0307543_125742_S1_M5_c4591001-S-D-suppce.zip (xpt) July 1, 2022 1 MB FDA-CBER-2021-5683-0286267 to -0296903_125742_S1_M5_c4591001-S-Supp-D-suppce.zip (xpt) July 1, 2022 2 MB FDA-CBER-2021-5683-0286072 to -0286266_125742_S1_M5_c4591001-S-Supp-D-relrec.zip (xpt) July 1, 2022 54 KB FDA-CBER-2021-5683-0285652 to -0286071_125742_S1_M5_c4591001-S-D-pe.zip (xpt) July 1, 2022 170 KB FDA-CBER-2021-5683-0285644 to -0285651_125742_S1_M5_c4591001-S-D-mo.zip (xpt) July 1, 2022 8 KB FDA-CBER-2021-5683-0282366 to -0285643_125742_S1_M5_c4591001-S-D-mb.zip (xpt) July 1, 2022 2 MB FDA-CBER-2021-5683-0282329 to -0282365_125742_S1_M5_c4591001-S-D-ie.zip (xpt) July 1, 2022 19 KB FDA-CBER-2021-5683-0282130 to -0282328_125742_S1_M5_c4591001-S-D-cm.zip (xpt) July 1, 2022 152 KB FDA-CBER-2021-5683-0225598 to -0282129_125742_S1_M5_c4591001-A-Supp-D-adfacevd.zip (xpt) July 1, 2022 84 MB FDA-CBER-2021-5683-0225100 to -0225597_125742_S1_M5_c4591001-A-D-adcm.zip (xpt) July 1, 2022 1 MB 125742_S2_M1_comvlabp vial puurs.pdf July 1, 2022 648 KB 125742_S2_M1_com195lpus carton puurs.pdf July 1, 2022 691 KB 125742_S2_M1_comvlabkz vial kzoo.pdf July 1, 2022 863 KB 125742_S2_M1_com25ctpus carton puurs.pdf July 1, 2022 672 KB 125742_S2_M1_com195lkz carton kzoo.pdf July 1, 2022 1,024 KB 125742_S2_M1_com25ctkz carton kzoo.pdf July 1, 2022 632 KB 125742_S1_M5_5351_c4591001 interim mth6 sap.pdf July 1, 2022 5 MB 125742_S1_M5_5351_c4591001 interim mth6 protocol deviations.pdf July 1, 2022 2 MB 125742_S1_M5_5351_c4591001 interim mth6 lab measurements sensitive.pdf July 1, 2022 5 MB 125742_S1_M5_5351_c4591001 interim mth6 excluded patients sensitive.pdf July 1, 2022 3 MB 125742_S1_M5_5351_c4591001 interim mth6 excluded patients.pdf July 1, 2022 1 MB 125742_S1_M5_5351_c4591001 interim mth6 errata.pdf July 1, 2022 2 MB 125742_S1_M5_5351_c4591001 interim mth6 efficacy response.pdf July 1, 2022 1 MB 125742_S1_M5_5351_c4591001 interim mth6 discontinued patients.pdf July 1, 2022 4 MB 125742_S1_M5_5351_c4591001 fa interim sap.pdf July 1, 2022 3 MB 125742_S1_M5_5351_c4591001 interim mth6 compliance sensitive.pdf July 1, 2022 1 MB 125742_S2_M1_right of reference.pdf July 1, 2022 2 MB 125742_S2_M1_loa dmf 031786 vials.pdf July 1, 2022 2 MB 125742_S2_M1_loa dmf 012683 vials.pdf July 1, 2022 631 KB 125742_S2_M1_loa dmf 011820 vials.pdf July 1, 2022 616 KB 125742_S2_M1_loa dmf 011793 vials.pdf July 1, 2022 701 KB 125742_S2_M1_loa dmf 011321 vials.pdf July 1, 2022 1,019 KB 125742_S2_M1_hospira diluent label.pdf July 1, 2022 776 KB 125742_S2_M1_loa dmf 10953 stopper.pdf July 1, 2022 861 KB 125742_S2_M1_hospira diluent carton.pdf July 1, 2022 987 KB 125742_S2_M1_fk diluent stamp.pdf July 1, 2022 598 KB 125742_S2_M1_fk diluent carton.pdf July 1, 2022 607 KB 125742_S2_M5_5354_wi235284-protocol.pdf July 1, 2022 16 MB 125742_S1_M5_5351_c4591001-interim-mth6-interlab-standard.pdf July 1, 2022 11 MB 125742_S1_M5_5351_c4591001-fa-interim-narrative-sensitive.pdf July 1, 2022 19 MB 125742_S1_M5_5351_c4591001-interim-mth6-adverse-events.zip (pdf) July 1, 2022 28 MB FDA-CBER-2021-5683-0208521 to -0216666_125742_S1_M5_c4591001-S-Supp-D-suppvs.zip (xpt) June 1, 2022 917 KB FDA-CBER-2021-5683-0205318 to -0208520_125742_S1_M5_c4591001-S-Supp-D-ex.zip (xpt) June 1, 2022 2 MB FDA-CBER-2021-5683-0196049 to -0205317_125742_S1_M5_c4591001-S-Supp-D-ce.zip (xpt) June 1, 2022 8 MB FDA-CBER-2021-5683-0187906 to -0196048_125742_S1_M5_c4591001-S-D-suppvs.zip (xpt) June 1, 2022 915 KB FDA-CBER-2021-5683-0182981 to -0187905_125742_S1_M5_c4591001-S-D-suppmh.zip (xpt) June 1, 2022 616 KB FDA-CBER-2021-5683-0180191 to -0182980_125742_S1_M5_c4591001-S-D-suppis.zip (xpt) June 1, 2022 350 KB FDA-CBER-2021-5683-0178319 to -0180190_125742_S1_M5_c4591001-S-D-suppho.zip (xpt) June 1, 2022 259 KB FDA-CBER-2021-5683-0174607 to -0178318_125742_S1_M5_c4591001-S-D-suppdv.zip (xpt) June 1, 2022 623 KB FDA-CBER-2021-5683-0171524 to -0174606_125742_S1_M5_c4591001-S-D-suppds.zip (xpt) June 1, 2022 405 KB FDA-CBER-2021-5683-0169082 to -0171523_125742_S1_M5_c4591001-S-D-suppdm.zip (xpt) June 1, 2022 334 KB FDA-CBER-2021-5683-0168683 to -0169081_125742_S1_M5_c4591001-S-D-suppcm.zip (xpt) June 1, 2022 71 KB FDA-CBER-2021-5683-0165893 to -0168682_125742_S1_M5_c4591001-S-D-is.zip (xpt) June 1, 2022 1 MB FDA-CBER-2021-5683-0162690 to -0165892_125742_S1_M5_c4591001-S-D-ex.zip (xpt) June 1, 2022 2 MB FDA-CBER-2021-5683-0159487 to -0162689_125742_S1_M5_c4591001-S-D-ec.zip (xpt) June 1, 2022 2 MB FDA-CBER-2021-5683-0158560 to -0159486_125742_S1_M5_c4591001-S-D-dv.zip (xpt) June 1, 2022 558 KB FDA-CBER-2021-5683-0149082 to -0158559_125742_S1_M5_c4591001-S-D-ce.zip (xpt) June 1, 2022 8 MB FDA-CBER-2021-5683-0142307 to -0149081_125742_S1_M5_c4591001-A-Supp-D-adcevd.zip (xpt) June 1, 2022 8 MB 125742_S1_M5_CRF_c4591001 1081 10811194 reissue.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1015 10151238.pdf June 1, 2022 3 MB 125742_S1_M5_CRF_c4591001 1015 10151225.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1015 10151134.pdf June 1, 2022 1 MB STN 125742 0 0 Section 2.5 Clinical Overview reissue.pdf June 1, 2022 5 MB 125742_S1_M5_CRF_c4591001 1128 11281009 reissue.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1015 10151089.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1015 10151047.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1015 10151071.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1015 10151035.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1015 10151011.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1013 10131786.pdf June 1, 2022 3 MB 125742_S1_M5_CRF_c4591001 1013 10131718.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1015 10151101.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1013 10131658.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1013 10131656.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1013 10131653.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1013 10131554.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1013 10131517.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1013 10131255.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1013 10131386.pdf June 1, 2022 1,008 KB 125742_S1_M5_CRF_c4591001 1013 10131229.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1013 10131699.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1013 10131176.pdf June 1, 2022 3 MB 125742_S1_M5_CRF_c4591001 1013 10131165.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1013 10131089.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1013 10131084.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1012 10121112.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1012 10121163.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1011 10111181.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1012 10121097.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1013 10131190.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1009 10091123.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1008 10081667.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1008 10081628.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1011 10111029.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1008 10081603.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1009 10091149.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1009 10091135.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1009 10091128.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1008 10081152.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1007 10071443.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1008 10081056.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1007 10071441.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1007 10071347.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1007 10071315.pdf June 1, 2022 1 MB 125742_S1_M5_CRF_c4591001 1007 10071306.pdf June 1, 2022 3 MB 125742_S1_M5_CRF_c4591001 1007 10071280.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1007 10071276.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1007 10071192.pdf June 1, 2022 2 MB 125742_S1_M5_CRF_c4591001 1007 10071159.pdf June 1, 2022 1 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biopharm.pdf June 1, 2022 2 MB 125742_S1_M5_5351_c4591001 interim mth6 randomization.pdf June 1, 2022 1 MB FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.zip (.xpt) May 2, 2022 7 MB FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.zip (.xpt) May 2, 2022 81 MB FDA-CBER-2021-5683-0059000 to -0065773_125742_S1_M5_c4591001-A-D-adcevd.zip (.xpt) May 2, 2022 9 MB FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xpt May 2, 2022 44 MB FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xsl May 2, 2022 183 KB FDA CBER 2021 5683 0058795 to 0058828_125742_S1_M5_bnt162 01 A define 2 0 0.xsl May 2, 2022 183 KB FDA CBER 2021 5683 0058829 to 0058954_125742_S1_M5_bnt162 01 S define.xml May 2, 2022 985 KB FDA CBER 2021 5683 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xml May 2, 2022 300 KB FDA CBER 2021 5683 0058653 to 0058675_125742_S1_M5_c4591001 S Supp define 2 0 0.xsl May 2, 2022 183 KB FDA CBER 2021 5683 0058676 to 0058794_125742_S1_M5_bnt162 01 A define.xsl May 2, 2022 828 KB FDA CBER 2021 5683 0058595 to 0058614_125742_S1_M5_c4591001 S define 2 0 0.xsl May 2, 2022 183 KB FDA CBER 2021 5683 0058459 to 0058478_125742_S1_M5_c4591001 A Supp define 2 0 0.xsl May 2, 2022 183 KB FDA CBER 2021 5683 0058479 to 0058594_125742_S1_M5_c4591001 S define.xml May 2, 2022 904 KB FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xml May 2, 2022 692 KB 125742_S1_M5_CRF_c4591001 1006 10061098.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1006 10061176.pdf May 2, 2022 3 MB 125742_S1_M5_CRF_c4591001 1006 10061094.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1006 10061040.pdf May 2, 2022 4 MB 125742_S1_M5_CRF_c4591001 1006 10061052.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1006 10061020.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1005 10051411.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1005 10051387.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1005 10051293.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1005 10051347.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1005 10051214.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1005 10051054.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1005 10051069.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1003 10031038.pdf May 2, 2022 3 MB 125742_S1_M5_CRF_c4591001 1001 10011100.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1001 10011135.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1001 10011093.pdf May 2, 2022 3 MB 125742_S1_M5_CRF_c4591001 1005 10051047.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1003 10031197.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1003 10031207.pdf May 2, 2022 1 MB 125742_S1_M5_CRF_c4591001 1003 10031186.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1003 10031149.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1003 10031113.pdf May 2, 2022 3 MB 125742_S1_M5_CRF_c4591001 1003 10031111.pdf May 2, 2022 2 MB 125742_S1_M5_CRF_c4591001 1003 10031065.pdf May 2, 2022 3 MB 125742_S1_M5_bnt162 01 S acrf.pdf May 2, 2022 1 MB 125742_S1_M5_bnt162 01 A adrg.pdf May 2, 2022 891 KB 125742_S1_M5_c4591001 S csdrg.pdf May 2, 2022 1 MB 125742_S1_M5_c4591001 S Supp acrf.pdf May 2, 2022 3 MB 125742_S1_M5_c4591001 S acrf.pdf May 2, 2022 3 MB 125742_S1_M5_bnt162 01 S csdrg.pdf May 2, 2022 1 MB 125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdf May 2, 2022 12 MB 125742_S1_M5_5351_c4591001 interim mth6 sample crf.pdf May 2, 2022 5 MB 125742_S1_M5_5351_c4591001 interim mth6 randomization sensitive.pdf May 2, 2022 65 MB 125742_S1_M5_5351_bnt162 01 interim3 sample crf.pdf May 2, 2022 9 MB 125742_S1_M5_5351_bnt162 01 interim3 report body.pdf May 2, 2022 42 MB 125742_S1_M5_5351_bnt162 01 interim3 protocol deviations.pdf May 2, 2022 1 MB 125742_S1_M5_5351_bnt162 01 interim3 protocol.pdf May 2, 2022 10 MB 125742_S1_M5_5351_bnt162 01 interim3 patient batches.pdf May 2, 2022 3 MB 125742_S1_M5_5351_bnt162 01 interim3 notes for reader.pdf May 2, 2022 1 MB 125742_S1_M5_5351_bnt162 01 interim3 synopsis.pdf May 2, 2022 4 MB 125742_S1_M5_5351_bnt162 01 interim3 sponsor signature.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01 interim3 sap.pdf May 2, 2022 3 MB 125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdf May 2, 2022 91 MB 125742_S1_M5_5351_bnt162 01 interim3 discontinued patients.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01 interim3 demographics.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01 interim3 compliance.pdf May 2, 2022 7 MB 125742_S1_M5_5351_bnt162 01 interim3 adverse events.pdf May 2, 2022 7 MB 125742_S1_M5_5351_bnt162 01 interim3 investigators.pdf May 2, 2022 6 MB 125742_S1_M5_5351_bnt162 01 interim3 invest signature.pdf May 2, 2022 634 KB 125742_S1_M5_5351_bnt162 01 interim3 iec irb.pdf May 2, 2022 1 MB 125742_S1_M5_5351_bnt162 01 interim3 excluded patients.pdf May 2, 2022 2 MB 125742_S1_M5_5351_bnt162 01_10075.pdf May 2, 2022 2 MB 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