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| FDA-CBER-2021-5683-0698920-0703842-125742_S1_M5_c4591001-S-D-suppae.xpt.zip | January 3, 2023 | 825 KB | |
| 125742_S58_M1_lab-1448-0-5-pkg-insert-track.pdf | January 3, 2023 | 879 KB | |
| FDA-CBER-2021-5683-0703843-0708840-125742_S1_M5_c4591001-S-Supp-D-suppae.xpt.zip | January 3, 2023 | 845 KB | |
| 125742_S64_M1_carton-com25ctkz-kzoo.pdf | January 3, 2023 | 217 KB | |
| 125742_S64_M1_carton-com25ctpus-puurs | January 3, 2023 | 242 KB | |
| 125742_S64_M1_carton-com195lkz-kzoo.pdf | January 3, 2023 | 135 KB | |
| 125742_S64_M1_carton-com195lpus-puurs | January 3, 2023 | 178 KB | |
| 125742_S64_M1_label-comvlabkz-kzoo.pdf | January 3, 2023 | 49 KB | |
| 125742_S64_M1_label-comvlabp-puurs.pdf | January 3, 2023 | 648 KB | |
| 125742_S64_M1_sticker-comdilrm.pdf | January 3, 2023 | 180 KB | |
| 125742_S68_M1_lab-1448-0-6-annotated.pdf | January 3, 2023 | 3 MB | |
| 125742_S68_M1_lab-1448-0-6-pkg-insert-clean.pdf | January 3, 2023 | 1 MB | |
| 4_BLA_125742-0_06-03-2021_First_Committee_Meeting_Summary.pdf | January 3, 2023 | 772 KB | |
| 7_BLA_125742-0_06-17-2021_Memo_Other.pdf | January 3, 2023 | 682 KB | |
| 10_BLA_125742-0_06-29-2021_Filing_Meeting_Summary.pdf | January 3, 2023 | 713 KB | |
| 125742_S68_M1_lab-1448-0-6-pkg-insert-track.pdf | January 3, 2023 | 1 MB | |
| 125742_S70_M1_lab-1448-0-7-annotated.pdf | January 3, 2023 | 2 MB | |
| 125742_S70_M1_lab-1448-0-7-pkg-insert-clean.pdf | January 3, 2023 | 1 MB | |
| 13_BLA_125742-0_07-02-2021_Committee Memo_APLB.pdf | January 3, 2023 | 848 KB | |
| 125742_S70_M1_lab-1448-0-7-pkg-insert-track.pdf | January 3, 2023 | 1 MB | |
| 36A_BLA_125742-0_07-28-2021_Telecon_Labeling Target Cl | January 3, 2023 | 1 MB | |
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| 125742_S73_M1_lab-1448-0-8-pkg-insert-clean.pdf | January 3, 2023 | 1 MB | |
| 72A_BLA_125742-0_08-13-2021_Telecon_Labeling via FAX_e.pdf | January 3, 2023 | 1 MB | |
| 77_BLA_125742-0_08-17-2021_Memo_Lot Release Clearance.pdf | January 3, 2023 | 805 KB | |
| 78_BLA_125742-0_08-17-2021_Memo_Other.pdf | January 3, 2023 | 814 KB | |
| 82A_BLA_125742-0_08-17-2021_Telecon_Labeling via FAX_e | January 3, 2023 | 1 MB | |
| 125742_S73_M1_lab-1448-0-8-pkg-insert-track.pdf | January 3, 2023 | 1 MB | |
| 91A_2_BLA_125742-0_08-18-2021_Telecon_Labeling via FAX_e.pdf | January 3, 2023 | 1 MB | |
| 125742_S76_M1_lab-1448-0-9-annotated.pdf | January 3, 2023 | 1 MB | |
| 125742_S76_M1_lab-1448-0-9-pkg-insert-clean.pdf | January 3, 2023 | 1 MB | |
| 98A_BLA_125742-0_08-19-2021_Telecon_Labeling via FAX_e.pdf | January 3, 2023 | 1 MB | |
| 125742_S76_M1_lab-1448-0-9-pkg-insert-track.pdf | January 3, 2023 | 1 MB | |
| FDA-CBER-2021-5683-0650114-0650115-125742_S1_M5_c4591001-S-D-ts | December 1, 2022 | 4 KB | |
| FDA-CBER-2021-5683-0634075-0650113-125742_S1_M5_c4591001-S-D-suppex | December 1, 2022 | 3 MB | |
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| FDA-CBER-2021-5683-0633790-0633944-125742_S1_M5_bnt162-01-S-D-adcevd | December 1, 2022 | 133 KB | |
| FDA-CBER-2021-5683-0623311-0633789-125742_S1_M5_c4591001-S-D-vs | December 1, 2022 | 8 MB | |
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| FDA-CBER-2021-5683-0600620-0616658-125742_S1_M5_c4591001-S-D-suppec | December 1, 2022 | 3 MB | |
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| FDA-CBER-2021-5683-0594977-0595464-125742_S1_M5_bnt162-01-S-D-suppvs | December 1, 2022 | 86 KB | |
| 125742_S1_M4_20256434.pdf.zip | November 1, 2022 | 20 MB | |
| FDA-CBER-2021-5683-0539816-0593326-125742_S1_M5_c4591001-01-S-Supp-D-face.xpt.zip | November 1, 2022 | 42 MB | |
| FDA-CBER-2021-5683-0593327-0593481-125742_S1_M5_bnt162-01-S-D-ce.xpt.zip | November 1, 2022 | 71 KB | |
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| FDA-CBER-2021-5683-0593596-0593620-125742_S1_M5_bnt162-01-S-D-se.xpt.zip | November 1, 2022 | 11 KB | |
| FDA-CBER-2021-5683-0593621-0593664-125742_S1_M5_bnt162-01-S-Supp-D-suppae.xpt.zip | November 1, 2022 | 6 KB | |
| FDA-CBER-2021-5683-0593665-0593743-125742_S1_M5_bnt162-01-S-Supp-D-suppcm.xpt.zip | November 1, 2022 | 19 KB | |
| FDA-CBER-2021-5683-0593744-0593769-125742_S1_M5_bnt162-01-S-Supp-D-suppds.xpt.zip | November 1, 2022 | 5 KB | |
| FDA-CBER-2021-5683-0593770-0593800-125742_S1_M5_bnt162-01-S-Supp-D-suppec.xpt.zip | November 1, 2022 | 7 KB | |
| FDA-CBER-2021-5683-0593801-0593831-125742_S1_M5_bnt162-01-S-Supp-D-suppex.xpt.zip | November 1, 2022 | 6 KB | |
| FDA CBER 2021 5683 0484461 0537913 125742_S1_M5_c4591001 S D face.zip (xpt) | October 3, 2022 | 52 MB | |
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| FDA-CBER-2021-5683-0396255-0484341_125742_S1_M5_c4591001-S-Supp-D-suppface.xpt | September 1, 2022 | 467 MB | |
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| FDA CBER 2021 5683 0396193 to 0396194_125742_S1_M5_c4591001 S D supppe.xpt | August 1, 2022 | 12 KB | |
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| FDA-CBER-2021-5683-0308157 to -0396186_125742_S1_M5_c4591001-S-D-suppface.xpt | August 1, 2022 | 467 MB | |
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| FDA CBER 2021 5683 0225598 to 0282129_125742_S1_M5_c4591001 A Supp D adfacevd.zip (xpt) | July 1, 2022 | 84 MB | |
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| 125742_S1_M5_5351_c4591001 interim mth6 lab measurements sensitive.pdf | July 1, 2022 | 5 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 interlab standard.pdf | July 1, 2022 | 11 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 excluded patients sensitive.pdf | July 1, 2022 | 3 MB | |
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| 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 | |
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| 125742_S1_M5_5351_c4591001 interim mth6 compliance sensitive.pdf | July 1, 2022 | 1 MB | |
| 125742_S2_M5_5354_wi235284 protocol.pdf | July 1, 2022 | 15 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_loa dmf 10953 stopper.pdf | July 1, 2022 | 861 KB | |
| 125742_S2_M1_hospira diluent label.pdf | July 1, 2022 | 776 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_M1_comvlabp vial puurs.pdf | July 1, 2022 | 648 KB | |
| 125742_S2_M1_comvlabkz vial kzoo.pdf | July 1, 2022 | 863 KB | |
| 125742_S2_M1_com195lpus carton puurs.pdf | July 1, 2022 | 691 KB | |
| 125742_S2_M1_com195lkz carton kzoo.pdf | July 1, 2022 | 1,024 KB | |
| 125742_S2_M1_com25ctpus carton puurs.pdf | July 1, 2022 | 672 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 | |
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| 125742_S1_M5_5351_c4591001 fa interim sap.pdf | July 1, 2022 | 3 MB | |
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| 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 | |
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| FDA CBER 2021 5683 0162690 to 0165892_125742_S1_M5_c4591001 S D ex.zip (xpt) | June 1, 2022 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1007 10071347.pdf | June 1, 2022 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1007 10071280.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 publications.pdf | June 1, 2022 | 11 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 patient batches.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001 fa interim protocol deviations sensitive.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001 fa interim patient batches.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001 fa interim discontinued patients.pdf | June 1, 2022 | 3 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 randomization.pdf | June 1, 2022 | 1 MB | |
| 125742_S1_M5_5314_shi sop 10011.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M2_summary biopharm.pdf | June 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001 fa interim adverse events.pdf | June 1, 2022 | 32 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 invest signature.pdf | May 2, 2022 | 634 KB | |
| 125742_S1_M5_5351_bnt162 01 interim3 investigators.pdf | May 2, 2022 | 6 MB | |
| 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 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_20242.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01_20215.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01_20116.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01_10075.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_5351_bnt162 01_10010.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdf | May 2, 2022 | 91 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_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 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 sample crf.pdf | May 2, 2022 | 9 MB | |
| 125742_S1_M5_c4591001 S Supp acrf.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_c4591001 S csdrg.pdf | May 2, 2022 | 1 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_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_CRF_c4591001 1006 10061176.pdf | May 2, 2022 | 3 MB | |
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| 125742_S1_M5_CRF_c4591001 1005 10051411.pdf | May 2, 2022 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1005 10051214.pdf | May 2, 2022 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1005 10051047.pdf | May 2, 2022 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1003 10031065.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1003 10031038.pdf | May 2, 2022 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1001 10011135.pdf | May 2, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1001 10011100.pdf | May 2, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1001 10011093.pdf | May 2, 2022 | 3 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 0058829 to 0058954_125742_S1_M5_bnt162 01 S define.xml | May 2, 2022 | 985 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 0058676 to 0058794_125742_S1_M5_bnt162 01 A define.xml | May 2, 2022 | 828 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 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xml | May 2, 2022 | 300 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 0058479 to 0058594_125742_S1_M5_c4591001 S define.xml | May 2, 2022 | 904 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 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xml | May 2, 2022 | 692 KB | |
| FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xpt | May 2, 2022 | 44 MB | |
| FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.zip (.xpt) | May 2, 2022 | 79 MB | |
| FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.zip (.xpt) | May 2, 2022 | 6 MB | |
| reissue_5.3.6 postmarketing experience.pdf | April 1, 2022 | 958 KB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdf | April 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf | April 1, 2022 | 28 MB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdf | April 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdf | April 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdf | April 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdf | April 1, 2022 | 5 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf | April 1, 2022 | 59 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-randomization.pdf | April 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-publications.pdf | April 1, 2022 | 10 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdf | April 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdf | April 1, 2022 | 677 KB | |
| 125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdf | April 1, 2022 | 8 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-demographics.pdf | April 1, 2022 | 28 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdf | April 1, 2022 | 869 KB | |
| 125742_S1_M1_priority-review-request.pdf | March 24, 2022 | 2 MB | |
| 125742_S1_M1_priority-review-request.pdf | March 24, 2022 | 2 MB | |
| FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsx | March 1, 2022 | 10 KB | |
| FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx | March 1, 2022 | 12 KB | |
| FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsx | March 1, 2022 | 17 KB | |
| FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsx | March 1, 2022 | 9 KB | |
| FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsx | March 1, 2022 | 10 KB | |
| FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx | March 1, 2022 | 10 KB | |
| FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsx | March 1, 2022 | 9 KB | |
| FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx | March 1, 2022 | 35 KB | |
| FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsx | March 1, 2022 | 12 KB | |
| FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx | March 1, 2022 | 84 KB | |
| FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx | March 1, 2022 | 23 KB | |
| FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx | March 1, 2022 | 18 KB | |
| FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx | March 1, 2022 | 19 KB | |
| FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx | March 1, 2022 | 22 KB | |
| FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx | March 1, 2022 | 13 KB | |
| FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsx | March 1, 2022 | 29 KB | |
| FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx | March 1, 2022 | 11 KB | |
| FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsx | March 1, 2022 | 24 KB | |
| FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx | March 1, 2022 | 21 KB | |
| FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx | March 1, 2022 | 12 KB | |
| FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx | March 1, 2022 | 12 KB | |
| FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsx | March 1, 2022 | 9 KB | |
| FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsx | March 1, 2022 | 9 KB | |
| FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsx | March 1, 2022 | 14 KB | |
| FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsx | March 1, 2022 | 9 KB | |
| FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsx | March 1, 2022 | 10 KB | |
| FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xsl | March 1, 2022 | 183 KB | |
| FDA-CBER-2021-5683-0023150 to -0023454_125742_S1_M5_c4591001-A-define.xml | March 1, 2022 | 1 MB | |
| FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txt | March 1, 2022 | 197 KB | |
| FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txt | March 1, 2022 | 75 KB | |
| FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txt | March 1, 2022 | 75 KB | |
| FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txt | March 1, 2022 | 29 KB | |
| FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt | March 1, 2022 | 24 KB | |
| FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txt | March 1, 2022 | 75 KB | |
| FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt | March 1, 2022 | 11 KB | |
| FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt | March 1, 2022 | 49 KB | |
| FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt | March 1, 2022 | 43 KB | |
| FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt | March 1, 2022 | 45 KB | |
| FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txt | March 1, 2022 | 12 KB | |
| FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txt | March 1, 2022 | 72 KB | |
| FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txt | March 1, 2022 | 20 KB | |
| FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txt | March 1, 2022 | 19 KB | |
| FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txt | March 1, 2022 | 18 KB | |
| FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txt | March 1, 2022 | 81 KB | |
| FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txt | March 1, 2022 | 15 KB | |
| FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txt | March 1, 2022 | 15 KB | |
| FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txt | March 1, 2022 | 35 KB | |
| FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txt | March 1, 2022 | 14 KB | |
| FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txt | March 1, 2022 | 15 KB | |
| FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt | March 1, 2022 | 32 KB | |
| FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txt | March 1, 2022 | 156 KB | |
| FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txt | March 1, 2022 | 27 KB | |
| FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txt | March 1, 2022 | 193 KB | |
| 125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_c4591001-A-report-cci-rheumatic.pdf | March 1, 2022 | 629 KB | |
| 125742_S1_M5_c4591001-A-report-cci-renal.pdf | March 1, 2022 | 629 KB | |
| 125742_S1_M5_c4591001-A-report-cci-pulmonary.pdf | March 1, 2022 | 630 KB | |
| 125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdf | March 1, 2022 | 632 KB | |
| 125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdf | March 1, 2022 | 625 KB | |
| 125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdf | March 1, 2022 | 626 KB | |
| 125742_S1_M5_CRF_c4591001-1085-10851246.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001-1085-10851216.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001-1085-10851129.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_CRF_c4591001-1085-10851116.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M5_CRF_c4591001-1085-10851018.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdf | March 1, 2022 | 17 MB | |
| 125742_S1_M5_c4591001-T-S-suppl-arg.pdf | March 1, 2022 | 738 KB | |
| 125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdf | March 1, 2022 | 667 KB | |
| 125742_S1_M5_c4591001-T-S-roadmap.pdf | March 1, 2022 | 703 KB | |
| 125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdf | March 1, 2022 | 627 KB | |
| 125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdf | March 1, 2022 | 626 KB | |
| 125742_S1_M5_c4591001-A-report-cci-dementia.pdf | March 1, 2022 | 626 KB | |
| 125742_S1_M5_c4591001-A-report-cci-chf.pdf | March 1, 2022 | 628 KB | |
| 125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdf | March 1, 2022 | 632 KB | |
| 125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdf | March 1, 2022 | 670 KB | |
| 125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdf | March 1, 2022 | 629 KB | |
| 125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdf | March 1, 2022 | 846 KB | |
| 125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdf | March 1, 2022 | 607 KB | |
| 125742_S1_M5_c4591001-A-comorbidity-categories.pdf | March 1, 2022 | 637 KB | |
| 125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdf | March 1, 2022 | 620 KB | |
| 125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdf | March 1, 2022 | 634 KB | |
| 125742_S1_M5_c4591001-A-report-cci-mild-liver.pdf | March 1, 2022 | 628 KB | |
| 125742_S1_M5_c4591001-A-report-cci-mi.pdf | March 1, 2022 | 624 KB | |
| 125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdf | March 1, 2022 | 636 KB | |
| 125742_S1_M5_c4591001-A-report-cci-lymphoma.pdf | March 1, 2022 | 640 KB | |
| 125742_S1_M5_c4591001-A-report-cci-leukemia.pdf | March 1, 2022 | 631 KB | |
| 125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdf | March 1, 2022 | 626 KB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf | March 1, 2022 | 37 MB | |
| 125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdf | March 1, 2022 | 13 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf | March 1, 2022 | 31 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdf | March 1, 2022 | 5 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdf | March 1, 2022 | 12 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf | March 1, 2022 | 16 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-errata.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M5_5351_c4591001-fa-interim-compliance.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdf | March 1, 2022 | 889 KB | |
| 125742_S1_M5_c4591001-A-bmi-12-15-scale.pdf | March 1, 2022 | 627 KB | |
| 125742_S1_M5_c4591001-A-adrg.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdf | March 1, 2022 | 602 KB | |
| 125742_S1_M1_us-agent-authorization.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M1_trans-of-oblig.pdf | March 1, 2022 | 717 KB | |
| 125742_S1_M1_ipsp-agreed-letter.pdf | March 1, 2022 | 658 KB | |
| 125742_S1_M1_financial-cert-bias.pdf | March 1, 2022 | 696 KB | |
| 125742_S1_M1_financial-cert-3454.pdf | March 1, 2022 | 3 MB | |
| 125742_S1_M1_fast-track-designation.pdf | March 1, 2022 | 649 KB | |
| 125742_S1_M1_exclusivity-claim.pdf | March 1, 2022 | 616 KB | |
| 125742_S1_M1_debarment.pdf | March 1, 2022 | 656 KB | |
| 125742_S1_M1_cover.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M1_3674.pdf | March 1, 2022 | 5 MB | |
| 125742_S1_M1_356h.pdf | March 1, 2022 | 714 KB | |
| 125742_S1_M4_4223_R-20-0072.pdf | March 1, 2022 | 5 MB | |
| 125742_S1_M4_4223_185350.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M2_27_synopses-indiv-studies.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M2_27_literature-references.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M2_26_pharmkin-written-summary.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M2_26_pharmkin-tabulated-summary.pdf | March 1, 2022 | 1 MB | |
| 125742_S1_M2_24_nonclinical-overview.pdf | March 1, 2022 | 2 MB | |
| 125742_S1_M2_22_introduction.pdf | March 1, 2022 | 670 KB | |
| 125742_S1_M1_waiver-req-designated-suffix.pdf | March 1, 2022 | 3 MB | |
| 125742_S1_M1_userfee.pdf | March 1, 2022 | 628 KB | |
| CRFs-for-site-1128.pdf | January 31, 2022 | 14 MB | |
| CRFs-for-site-1096.pdf | January 18, 2022 | 11 MB | |
| CRFs-for-site-1081.pdf | December 30, 2021 | 13 MB | |
| Supplemental-Index-12-22-21.pdf | December 22, 2021 | 2 MB | |
| STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdf | December 13, 2021 | 6 MB | |
| STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdf | December 13, 2021 | 3 MB | |
| STN-125742_0_0-Section-2.5-Clinical-Overview.pdf | December 13, 2021 | 4 MB | |
| signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf | December 13, 2021 | 207 KB | |
| CRFs-for-site-1055.pdf | December 13, 2021 | 6 MB | |
| BATES-FDA-CBER-2021-5683-0002379_te.xpt | December 13, 2021 | 3 KB | |
| BATES-FDA-CBER-2021-5683-0002380_ti.xpt | December 13, 2021 | 37 KB | |
| BATES-FDA-CBER-2021-5683-0002377_supppr.xpt | December 13, 2021 | 72 KB | |
| BATES-FDA-CBER-2021-5683-0002378_ta.xpt | December 13, 2021 | 8 KB | |
| BATES-FDA-CBER-2021-5683-0002376_relrec.xpt | December 13, 2021 | 567 KB | |
| BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt | December 13, 2021 | 5 KB | |
| BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt | December 13, 2021 | 9 KB | |
| BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt | December 13, 2021 | 9 KB | |
| BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt | December 13, 2021 | 9 KB | |
| Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdf | December 1, 2021 | 14 MB | |
| Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdf | December 1, 2021 | 12 MB | |
| BATES-93_tv.xpt | November 17, 2021 | 16 KB | |
| 5.2-tabular-listing.pdf | November 17, 2021 | 2 MB | |
| 5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdf | November 17, 2021 | 8 MB | |
| BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txt | November 17, 2021 | 9 KB | |
| 5.3.6-postmarketing-experience.pdf | November 17, 2021 | 984 KB | |