Get Involved Now!
Aenean ipsum magna, cursus eget orci ac, luctus fringilla eros. Sed Leo purus, dapibus in pulvinar et, euismod vitae est. Maecenas laoreet arcu eget tortor euismod tincidunt. Phasellus eu consectetur nisi. Proin condimentum mi vel lacus finibus fermentum.
Title | Date | File Size | Link |
---|---|---|---|
FDA CBER 2021 5683 0776793 0777994_125742_S1_M5_C4591001 S D_dm.zip | March 1, 2023 | 1 MB | |
FDA CBER 2021 5683 0776792_125742_S1_M5_C4591001 S D_dd.zip | March 1, 2023 | 3 KB | |
FDA CBER 2021 5683 0775805 0776791_125742_S1_M5_C4591001 S D_ae.zip | March 1, 2023 | 2 MB | |
FDA CBER 2021 5683 0774873 0775804_125742_S1_M5_C4591001 A D_adae.zip | March 1, 2023 | 6 MB | |
FDA CBER 2021 5683 0773671 0774872_125742_S1_M5_C4591001 A Supp D adsl.zip | March 1, 2023 | 7 MB | |
FDA CBER 2021 5683 0772469 0773670_125742_S1_M5_C4591001 A D_adsl.zip | March 1, 2023 | 7 MB | |
FDA CBER 2021 5683 0772467 0772468_125742_S1_M5_bnt162 01 S D_ts.zip | March 1, 2023 | 4 KB | |
FDA CBER 2021 5683 0772418 0772466_125742_S1_M5_bnt162 01 S D_sv.zip | March 1, 2023 | 19 KB | |
FDA CBER 2021 5683 0772290 0772417_125742_S1_M5_bnt162 01 S D_supplb.xpt.zip | March 1, 2023 | 21 KB | |
FDA CBER 2021 5683 0772254 0772289_125742_S1_M5_bnt162 01 S D_mb.zip | March 1, 2023 | 18 KB | |
FDA CBER 2021 5683 0772182 0772253_125742_S1_M5_bnt162 01 S D_is.zip | March 1, 2023 | 77 KB | |
FDA CBER 2021 5683 0772160 0772181_125742_S1_M4_20gr142 D_vs.zip | March 1, 2023 | 14 KB | |
FDA CBER 2021 5683 0772125 0772159_125742_S1_M4_38166 D_vs.zip | March 1, 2023 | 12 KB | |
FDA CBER 2021 5683 0772120 0772124_125742_S1_M4_38166 D_tx.zip | March 1, 2023 | 3 KB | |
FDA CBER 2021 5683 0772119_125742_S1_M4_20gr142 D_tx.zip | March 1, 2023 | 1 KB | |
FDA CBER 2021 5683 0772118_125742_S1_M4_38166 D_ts.zip | March 1, 2023 | 3 KB | |
FDA CBER 2021 5683 0772117_125742_S1_M4_20gr142 D_ts.zip | March 1, 2023 | 2 KB | |
FDA CBER 2021 5683 0772116_125742_S1_M4_38166 D_te.zip | March 1, 2023 | 779 B | |
FDA CBER 2021 5683 0772115_125742_S1_M4_20gr142 D_te.zip | March 1, 2023 | 749 B | |
FDA CBER 2021 5683 0772114_125742_S1_M4_38166 D_ta.zip | March 1, 2023 | 1,014 B | |
FDA CBER 2021 5683 0772113_125742_S1_M4_20gr142 D_ta.zip | March 1, 2023 | 827 B | |
FDA CBER 2021 5683 0772068 0772112_125742_S1_M4_20gr142 D_suppvs.zip | March 1, 2023 | 7 KB | |
FDA CBER 2021 5683 0772061 0772067_125742_S1_M4_20gr142 D_suppmi.zip | March 1, 2023 | 3 KB | |
FDA CBER 2021 5683 0771971 0772060_125742_S1_M4_38166 D_suppmi.zip | March 1, 2023 | 19 KB | |
FDA CBER 2021 5683 0771970_125742_S1_M4_38166 D_suppma.zip | March 1, 2023 | 1 KB | |
FDA CBER 2021 5683 0771969_125742_S1_M4_20gr142 D_suppma.zip | March 1, 2023 | 1 KB | |
FDA CBER 2021 5683 0779202 0779206_125742_S1_M5_bnt162 01 S Supp D_suppdm.zip | March 1, 2023 | 2 KB | |
FDA CBER 2021 5683 0779197 0779201_125742_S1_M5_bnt162 01 A D_adsl.zip | March 1, 2023 | 26 KB | |
FDA CBER 2021 5683 0777995 0779196_125742_S1_M5_C4591001 S Supp_dm.zip | March 1, 2023 | 1 MB | |
FDA CBER 2021 5683 0771516 0771519_125742_S1_M4_20gr142 D_suppds.zip | March 1, 2023 | 2 KB | |
FDA CBER 2021 5683 0771095 0771515_125742_S1_M4_20gr142 D_suppcl.zip | March 1, 2023 | 64 KB | |
FDA CBER 2021 5683 0771049 0771094_125742_S1_M4_20gr142 D_suppbw.zip | March 1, 2023 | 8 KB | |
FDA CBER 2021 5683 0770974 0771048_125742_S1_M4_20gr142 D_suppbg.zip | March 1, 2023 | 12 KB | |
FDA CBER 2021 5683 0770969 0770973_125742_S1_M4_20gr142 D_se.zip | March 1, 2023 | 2 KB | |
FDA CBER 2021 5683 0770955 0770968_125742_S1_M4_38166 D_se.zip | March 1, 2023 | 3 KB | |
FDA CBER 2021 5683 0770953 0770954_125742_S1_M4_20gr142 D_relrec.zip | March 1, 2023 | 1 KB | |
FDA CBER 2021 5683 0770914 0770952_125742_S1_M4_38166 D_relrec.zip | March 1, 2023 | 5 KB | |
FDA CBER 2021 5683 0770912 0770913_125742_S1_M4_20gr142 D_pooldef.zip | March 1, 2023 | 1 KB | |
FDA CBER 2021 5683 0770852 0770911_125742_S1_M4_20gr142 D_om.zip | March 1, 2023 | 48 KB | |
FDA CBER 2021 5683 0770669 0770851_125742_S1_M4_38166 D_om.zip | March 1, 2023 | 120 KB | |
FDA CBER 2021 5683 0770591 0770668_125742_S1_M4_20gr142 D_mi.zip | March 1, 2023 | 44 KB | |
FDA CBER 2021 5683 0770196 0770590_125742_S1_M4_38166 D_mi.zip | March 1, 2023 | 214 KB | |
FDA CBER 2021 5683 0770089 0770195_125742_S1_M4_20gr142 D_ma.zip | March 1, 2023 | 50 KB | |
FDA CBER 2021 5683 0769836 0770088_125742_S1_M4_38166 D_ma.zip | March 1, 2023 | 68 KB | |
FDA CBER 2021 5683 0769635 0769835_125742_S1_M4_20gr142 D_lb.zip | March 1, 2023 | 212 KB | |
FDA CBER 2021 5683 0769068 0769634_125742_S1_M4_38166 D_lb.zip | March 1, 2023 | 696 KB | |
FDA CBER 2021 5683 0769055 0769067_125742_S1_M4_20gr142 D_fw.zip | March 1, 2023 | 13 KB | |
FDA CBER 2021 5683 0769040 0769054_125742_S1_M4_38166 D_fw.zip | March 1, 2023 | 13 KB | |
FDA CBER 2021 5683 0769034 0769039_125742_S1_M4_20gr142 D_ex.zip | March 1, 2023 | 4 KB | |
FDA CBER 2021 5683 0769022 0769033_125742_S1_M4_38166 D_ex.zip | March 1, 2023 | 7 KB | |
FDA CBER 2021 5683 0769020 0769021_125742_S1_M4_20gr142 D_ds.zip | March 1, 2023 | 2 KB | |
FDA CBER 2021 5683 0769014 0769019_125742_S1_M4_38166 D_ds.zip | March 1, 2023 | 2 KB | |
FDA CBER 2021 5683 0769012 0769013_125742_S1_M4_20gr142 D_dm.zip | March 1, 2023 | 3 KB | |
FDA CBER 2021 5683 0769006 0769011_125742_S1_M4_38166 D_dm.zip | March 1, 2023 | 2 KB | |
FDA CBER 2021 5683 0769005_125742_S1_M4_20gr142 D_co.zip | March 1, 2023 | 2 KB | |
FDA CBER 2021 5683 0769003 0769004_125742_S1_M4_38166 D_co.zip | March 1, 2023 | 1 KB | |
FDA CBER 2021 5683 0768793 0769002_125742_S1_M4_20gr142 D_cl.zip | March 1, 2023 | 151 KB | |
FDA CBER 2021 5683 0768324 0768792_125742_S1_M4_38166 D_cl.zip | March 1, 2023 | 129 KB | |
FDA CBER 2021 5683 0768301 0768323_125742_S1_M4_20gr142 D_bw.zip | March 1, 2023 | 20 KB | |
FDA CBER 2021 5683 0768245 0768300_125742_S1_M4_38166 D_bw.zip | March 1, 2023 | 42 KB | |
FDA CBER 2021 5683 0768227 0768244_125742_S1_M4_20gr142 D_bg.zip | March 1, 2023 | 17 KB | |
FDA CBER 2021 5683 0768189 0768226_125742_S1_M4_38166 D_bg.zip | March 1, 2023 | 21 KB | |
FDA CBER 2021 5683 0768159 0768188_125742_S1_M4_38166_define2 0 0.zip | March 1, 2023 | 14 KB | |
FDA CBER 2021 5683 0768093 0768158_125742_S1_M4_38166_define.zip | March 1, 2023 | 28 KB | |
FDA CBER 2021 5683 0768063 0768092_125742_S1_M4_20gr142_define2 0 0.zip | March 1, 2023 | 14 KB | |
FDA CBER 2021 5683 0767981 0768062_125742_S1_M4_20gr142_define.zip | March 1, 2023 | 21 KB | |
FDA CBER 2021 5683 0771560 0771968_125742_S1_M4_20gr142 D_supplb.zip | March 1, 2023 | 53 KB | |
FDA CBER 2021 5683 0771520 0771559_125742_S1_M4_20gr142 D_suppfw.zip | March 1, 2023 | 7 KB | |
125742_S1_M4_20gr142_nsdrg.pdf | March 1, 2023 | 818 KB | |
125742_S1_M4_4.2.3.2 38166.pdf | March 1, 2023 | 21 MB | |
125742_S1_M4_38166_nsdrg.pdf | March 1, 2023 | 856 KB | |
pd production 030123.zip | March 1, 2023 | 45 MB | |
FDA CBER 2021 5683 0764727 0765714 125742_S1_M5_c4591001 S Supp D ae supp.zip | February 1, 2023 | 2 MB | |
FDA CBER 2021 5683 0764726 125742_S1_M5_c4591001 S D di.zip | February 1, 2023 | 2 KB | |
FDA CBER 2021 5683 0763794 0764725 125742_S1_M5_c4591001 A Supp D adae supp.zip | February 1, 2023 | 6 MB | |
FDA CBER 2021 5683 0710069 0763793 125742_S1_M5_c4591001 A D adc19ef.zip | February 1, 2023 | 33 MB | |
FDA CBER 2021 5683 0710059 0710068 125742_S1_M5_bnt162 01 S D co.zip | February 1, 2023 | 13 KB | |
125742_S1_M4_4.2.2.4 01049 20010.pdf | February 1, 2023 | 2 MB | |
125742_S1_M4_4.2.2.4 01049 20009.pdf | February 1, 2023 | 2 MB | |
125742_S1_M4_4.2.2.4 01049 20008.pdf | February 1, 2023 | 1 MB | |
125742_S1_M4_4.2.2.1 vr vtr 10671.pdf | February 1, 2023 | 5 MB | |
125742_S1_M4_4.2.2 072424.pdf | February 1, 2023 | 2 MB | |
125742_S1_M4_4.2.1 vr vtr 10741.pdf | February 1, 2023 | 3 MB | |
125742_S1_M4_4.2.1 r 20 0211.pdf | February 1, 2023 | 2 MB | |
125742_S1_M4_4.2.1 r 20 0112.pdf | February 1, 2023 | 5 MB | |
125742_S1_M4_4.2.1 r 20 0085.pdf | February 1, 2023 | 23 MB | |
125742_S1_M2_2.6.7.1toxicology tabulated summary.pdf | February 1, 2023 | 960 KB | |
125742_S1_M2_2.6.6 toxicology written summary.pdf | February 1, 2023 | 2 MB | |
125742_S1_M2_2.6.3.1 pharmacol tabulated summary | February 1, 2023 | 2 MB | |
125742_S1_M2_2.6.2 pharmacol written summary.pdf | February 1, 2023 | 7 MB | |
125742_S1_M2_2.6.1 introduction.pdf | February 1, 2023 | 2 MB | |
125742_S1_M4_4.3 munster jv 2020.pdf | February 1, 2023 | 3 MB | |
125742_S1_M4_4.2.3.2 20gr142.pdf | February 1, 2023 | 18 MB | |
125742_S1_M4_4.2.2.4 043725.pdf | February 1, 2023 | 12 MB | |
125742_S1_M4_4.2.2.4 01049 20022.pdf | February 1, 2023 | 2 MB | |
125742_S1_M4_4.2.2.4 01049 20021.pdf | February 1, 2023 | 2 MB | |
125742_S1_M4_4.2.2.4 01049 20020.pdf | February 1, 2023 | 2 MB | |
pd-production-020123.zip | February 1, 2023 | 126 MB | |
125742_S68_M1_lab-1448-0-6-pkg-insert-clean.pdf | January 3, 2023 | 1 MB | |
125742_S68_M1_lab-1448-0-6-annotated.pdf | January 3, 2023 | 3 MB | |
125742_S64_M1_sticker-comdilrm.pdf | January 3, 2023 | 180 KB | |
125742_S64_M1_label-comvlabp-puurs.pdf | January 3, 2023 | 648 KB | |
125742_S64_M1_label-comvlabkz-kzoo.pdf | January 3, 2023 | 49 KB | |
125742_S64_M1_carton-com195lpus-puurs | January 3, 2023 | 178 KB | |
125742_S64_M1_carton-com195lkz-kzoo.pdf | January 3, 2023 | 135 KB | |
125742_S64_M1_carton-com25ctpus-puurs | January 3, 2023 | 242 KB | |
125742_S64_M1_carton-com25ctkz-kzoo.pdf | January 3, 2023 | 217 KB | |
FDA-CBER-2021-5683-0703843-0708840-125742_S1_M5_c4591001-S-Supp-D-suppae.xpt.zip | January 3, 2023 | 845 KB | |
125742_S58_M1_lab-1448-0-5-pkg-insert-track.pdf | January 3, 2023 | 879 KB | |
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-clean.pdf | January 3, 2023 | 878 KB | |
FDA-CBER-2021-5683-0688438-0698919-125742_S1_M5_c4591001-S-D-vs.xpt.zip | January 3, 2023 | 7 MB | |
125742_S58_M1_lab-1448-0-5-annotated.pdf | January 3, 2023 | 3 MB | |
FDA-CBER-2021-5683-0681346-0688437-125742_S1_M5_c4591001-S-D-ds.xpt.zip | January 3, 2023 | 2 MB | |
125742_S54_M1_carton-com195lpus-puurs.pdf | January 3, 2023 | 179 KB | |
125742_S54_M1_carton-com195lkz-kzoo | January 3, 2023 | 135 KB | |
FDA-CBER-2021-5683-0678268-0681345-125742_S1_M5_c4591001-A-D-adds.xpt.zip | January 3, 2023 | 7 MB | |
FDA-CBER-2021-5683-0674998-0678267-125742_S1_M5_c4591001-S-Supp-D-suppmb.xpt.zip | January 3, 2023 | 438 KB | |
FDA-CBER-2021-5683-0671345-0674997-125742_S1_M5_c4591001-S-D-supplb.xpt.zip | January 3, 2023 | 504 KB | |
125742_S54_M1_carton-com25ctpus-puurs.pdf | January 3, 2023 | 691 KB | |
FDA-CBER-2021-5683-0663135-0671344-125742_S1_M5_c4591001-A-D-adsympt.xpt.zip | January 3, 2023 | 4 MB | |
125742_S54_M1_carton-com25ctkz-kzoo.pdf | January 3, 2023 | 218 KB | |
FDA-CBER-2021-5683-0661614-0663134-125742_S1_M5_bnt162-01-S-D-lb.xpt.zip | January 3, 2023 | 1 MB | |
125742_S51_M5_5351_c4591001-followup-table.pdf | January 3, 2023 | 606 KB | |
FDA-CBER-2021-5683-0658060-0661613-125742_S1_M5_bnt162-01-S-D-face.xpt.xpt.zip | January 3, 2023 | 2 MB | |
125742_S51_M1_lab-1448-0-4-pkg-insert-track.pdf | January 3, 2023 | 1 MB | |
FDA-CBER-2021-5683-0654507-0658059-125742_S1_M5_bnt162-01-S-Supp-D-suppface.xpt.zip | January 3, 2023 | 612 KB | |
125742_S51_M1_lab-1448-0-4-pkg-insert-clean.pdf | January 3, 2023 | 1 MB | |
125742_S51_M1_lab-1448-0-4-annotated | January 3, 2023 | 4 MB | |
125742_S46_M1_sticker-comdilrm.pdf | January 3, 2023 | 56 KB | |
125742_S46_M1_label-comvlabp-puurs.pdf | January 3, 2023 | 55 KB | |
125742_S46_M1_label-comvlabkz-kzoo.pdf | January 3, 2023 | 49 KB | |
FDA-CBER-2021-5683-0652981-0654506-125742_S1_M5_bnt162-01-A-D-adlb.xpt.zip | January 3, 2023 | 3 MB | |
125742_S46_M1_carton-com195lpus-puurs.pdf | January 3, 2023 | 179 KB | |
FDA-CBER-2021-5683-0652961-0652980-125742_S80_M1_lab-1448-1-0-pkg-insert-clean.docx | January 3, 2023 | 515 KB | |
FDA-CBER-2021-5683-0652941-0652960-125742_S79_M1_lab-1448-1-0-pkg-insert-clean.docx | January 3, 2023 | 515 KB | |
125742_S46_M1_carton-com195lkz-kzoo.pdf | January 3, 2023 | 140 KB | |
FDA-CBER-2021-5683-0652920-0652940-125742_S76_M1_lab-1448-0-9-annotated.docx | January 3, 2023 | 519 KB | |
125742_S46_M1_carton-com25ctpus-puurs.pdf | January 3, 2023 | 241 KB | |
FDA-CBER-2021-5683-0652899-0652919-125742_S76_M1_lab-1448-0-9-pkg-insert-track.docx | January 3, 2023 | 515 KB | |
FDA-CBER-2021-5683-0652879-0652898-125742_S76_M1_lab-1448-0-9-pkg-insert-clean.docx | January 3, 2023 | 515 KB | |
125742_S46_M1_carton-com25ctkz-kzoo | January 3, 2023 | 217 KB | |
FDA-CBER-2021-5683-0652859-0652878-125742_S73_M1_lab-1448-0-8-pkg-insert-track.docx | January 3, 2023 | 516 KB | |
FDA-CBER-2021-5683-0652839-0652858-125742_S73_M1_lab-1448-0-8-annotated.docx | January 3, 2023 | 521 KB | |
125742_S41_M1_c4591001-ve-tables.pdf | January 3, 2023 | 695 KB | |
FDA-CBER-2021-5683-0652819-0652838-125742_S73_M1_lab-1448-0-8-pkg-insert-clean.docx | January 3, 2023 | 515 KB | |
FDA-CBER-2021-5683-0652798-0652818-125742_S70_M1_lab-1448-0-7-pkg-insert-track.docx | January 3, 2023 | 515 KB | |
125742_S39_M1_lab-1448-0-3-pkg-insert-track.pdf | January 3, 2023 | 5 MB | |
FDA-CBER-2021-5683-0652777-0652797-125742_S70_M1_lab-1448-0-7-pkg-insert-clean.docx | January 3, 2023 | 522 KB | |
FDA-CBER-2021-5683-0652756-0652776-125742_S70_M1_lab-1448-0-7-annotated.docx | January 3, 2023 | 520 KB | |
125742_S39_M1_lab-1448-0-3-pkg-insert-clean | January 3, 2023 | 5 MB | |
FDA-CBER-2021-5683-0652735-0652755-125742_S68_M1_lab-1448-0-6-pkg-insert-track.docx | January 3, 2023 | 515 KB | |
FDA-CBER-2021-5683-0652714-0652734-125742_S68_M1_lab-1448-0-6-pkg-insert-clean.docx | January 3, 2023 | 514 KB | |
125742_S39_M1_lab-1448-0-3-annotated.pdf | January 3, 2023 | 6 MB | |
FDA-CBER-2021-5683-0652693-0652713-125742_S68_M1_lab-1448-0-6-annotated.docx | January 3, 2023 | 520 KB | |
125742_S39_M1_5351_c4591001-ve-tables.pdf | January 3, 2023 | 695 KB | |
FDA-CBER-2021-5683-0652673-0652692-125742_S58_M1_lab-1448-0-5-pkg-insert-clean.docx | January 3, 2023 | 514 KB | |
125742_S38_M5_c4591001-508-safety-tables.pdf | January 3, 2023 | 928 KB | |
FDA-CBER-2021-5683-0652653-0652672-125742_S58_M1_lab-1448-0-5-pkg-insert-track.docx | January 3, 2023 | 514 KB | |
FDA-CBER-2021-5683-0652633-0652652-125742_S58_M1_lab-1448-0-5-annotated.docx | January 3, 2023 | 523 KB | |
125742_S33_M5_5351_c4591001-508-efficacy-tables.pdf | January 3, 2023 | 821 KB | |
FDA-CBER-2021-5683-0652612-0652632-125742_S51_M1_lab-1448-0-4-pkg-insert-clean.docx | January 3, 2023 | 513 KB | |
125742_S29_M1_lab-1448-0-2-pkg-insert-track | January 3, 2023 | 1 MB | |
FDA-CBER-2021-5683-0652591-0652611-125742_S51_M1_lab-1448-0-4-annotated.docx | January 3, 2023 | 539 KB | |
FDA-CBER-2021-5683-0652570-0652590-125742_S51_M1_lab-1448-0-4-pkg-insert-track.docx | January 3, 2023 | 522 KB | |
125742_S29_M1_lab-1448-0-2-pkg-insert-clean.pdf | January 3, 2023 | 1 MB | |
FDA-CBER-2021-5683-0652548-0652569-125742_S39_M1_lab-1448-0-3-pkg-insert-clean.doc.zip | January 3, 2023 | 458 KB | |
FDA-CBER-2021-5683-0652526-0652547-125742_S39_M1_lab-1448-0-3-annotated.doc.zip | January 3, 2023 | 494 KB | |
125742_S29_M1_lab-1448-0-2-annotated.pdf | January 3, 2023 | 3 MB | |
125742_S28_M1_response-22jul2021-followup.pdf | January 3, 2023 | 767 KB | |
FDA-CBER-2021-5683-0652504-0652525-125742_S39_M1_lab-1448-0-3-pkg-insert-track.doc.zip | January 3, 2023 | 484 KB | |
125742_S27_M1_response-29jul2021 | January 3, 2023 | 1 MB | |
FDA-CBER-2021-5683-0652472-0652503-125742_S38_M5_c4591001-508-safety-tables.doc.docx | January 3, 2023 | 73 KB | |
FDA-CBER-2021-5683-0652443-0652471-125742_S33_M5_5351_c4591001-508-efficacy-tables.doc.zip | January 3, 2023 | 53 KB | |
125742_S21_M1_pvp-track.pdf | January 3, 2023 | 8 MB | |
125742_S21_M1_pharmacovigilance-plan | January 3, 2023 | 13 MB | |
125742_S16_M1_psp-track.pdf | January 3, 2023 | 922 KB | |
125742_S16_M1_ped-studies-deferral-track-change.pdf | January 3, 2023 | 664 KB | |
125742_S13_M5_5351_c4591001-narrative-1226-12262255 | January 3, 2023 | 626 KB | |
125742_S13_M5_5351_c4591001-adae-hiv-listing.pdf | January 3, 2023 | 683 KB | |
125742_S12_M1_waiver-req-preservative.pdf | January 3, 2023 | 710 KB | |
125742_S12_M1_13jul2021-response.pdf | January 3, 2023 | 1 MB | |
125742_S7_M1_response-08jun2021 | January 3, 2023 | 1 MB | |
125742_S6_M5_5351_c4591001-sequencing-listings.pdf | January 3, 2023 | 4 MB | |
125742_S1_M5_5351_c4591001-interim-mth6-iec-irb-consent-form.pdf | January 3, 2023 | 10 MB | |
FDA-CBER-2021-5683-0652414-0652442-125742_S29_M1_lab-1448-0-2-pkg-insert-track.doc.zip | January 3, 2023 | 529 KB | |
130_BLA _125742-0_09-01-2021_Committee Memo_Labeling.pdf | January 3, 2023 | 771 KB | |
FDA-CBER-2021-5683-0652385-0652413-125742_S29_M1_lab-1448-0-2-pkg-insert-clean.docx | January 3, 2023 | 535 KB | |
126_BLA 125742-0_08-23-2021_Memo_Other | January 3, 2023 | 649 KB | |
125742_S80_M1_lab-1448-1-0-pkg-insert-clean.pdf | January 3, 2023 | 875 KB | |
114A_2_BLA_125742-0_08-21-2021_Telecon_Labeling via FAX_e.pdf | January 3, 2023 | 1 MB | |
125742_S79_M1_lab-1448-1-0-pkg-insert-clean.pdf | January 3, 2023 | 875 KB | |
106A_2_BLA_125742-0_08-20-2021_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 | |
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-clean.pdf | January 3, 2023 | 1 MB | |
125742_S76_M1_lab-1448-0-9-annotated.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_S73_M1_lab-1448-0-8-pkg-insert-track.pdf | January 3, 2023 | 1 MB | |
82A_BLA_125742-0_08-17-2021_Telecon_Labeling via FAX_e | January 3, 2023 | 1 MB | |
78_BLA_125742-0_08-17-2021_Memo_Other.pdf | January 3, 2023 | 814 KB | |
77_BLA_125742-0_08-17-2021_Memo_Lot Release Clearance.pdf | January 3, 2023 | 805 KB | |
72A_BLA_125742-0_08-13-2021_Telecon_Labeling via FAX_e.pdf | January 3, 2023 | 1 MB | |
125742_S73_M1_lab-1448-0-8-pkg-insert-clean.pdf | January 3, 2023 | 1 MB | |
125742_S73_M1_lab-1448-0-8-annotated.pdf | January 3, 2023 | 3 MB | |
36A_BLA_125742-0_07-28-2021_Telecon_Labeling Target Cl | January 3, 2023 | 1 MB | |
125742_S70_M1_lab-1448-0-7-pkg-insert-track.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-clean.pdf | January 3, 2023 | 1 MB | |
125742_S70_M1_lab-1448-0-7-annotated.pdf | January 3, 2023 | 2 MB | |
125742_S68_M1_lab-1448-0-6-pkg-insert-track.pdf | January 3, 2023 | 1 MB | |
10_BLA_125742-0_06-29-2021_Filing_Meeting_Summary.pdf | January 3, 2023 | 713 KB | |
7_BLA_125742-0_06-17-2021_Memo_Other.pdf | January 3, 2023 | 682 KB | |
4_BLA_125742-0_06-03-2021_First_Committee_Meeting_Summary.pdf | January 3, 2023 | 772 KB | |
pd-production-010323-2.zip | January 3, 2023 | 30 MB | |
pd-production-010323-1.zip | January 3, 2023 | 124 MB | |
FDA-CBER-2021-5683-0594977-0595464-125742_S1_M5_bnt162-01-S-D-suppvs | December 1, 2022 | 86 KB | |
FDA-CBER-2021-5683-0595465-0595943-125742_S1_M5_bnt162-01-S-D-vs | December 1, 2022 | 391 KB | |
FDA-CBER-2021-5683-0595944-0600619-125742_S1_M5_c4591001-S-D-se | December 1, 2022 | 2 MB | |
FDA-CBER-2021-5683-0600620-0616658-125742_S1_M5_c4591001-S-D-suppec | December 1, 2022 | 3 MB | |
FDA-CBER-2021-5683-0616659-0623310-125742_S1_M5_c4591001-S-D-sv | December 1, 2022 | 2 MB | |
FDA-CBER-2021-5683-0623311-0633789-125742_S1_M5_c4591001-S-D-vs | December 1, 2022 | 8 MB | |
FDA-CBER-2021-5683-0633790-0633944-125742_S1_M5_bnt162-01-S-D-adcevd | December 1, 2022 | 133 KB | |
FDA-CBER-2021-5683-0633945-0634074-125742_S1_M5_bnt162-01-S-D-adva | December 1, 2022 | 169 KB | |
FDA-CBER-2021-5683-0634075-0650113-125742_S1_M5_c4591001-S-D-suppex | December 1, 2022 | 3 MB | |
FDA-CBER-2021-5683-0650114-0650115-125742_S1_M5_c4591001-S-D-ts | December 1, 2022 | 4 KB | |
pd-production-120122.zip | December 1, 2022 | 20 MB | |
FDA-CBER-2021-5683-0593801-0593831-125742_S1_M5_bnt162-01-S-Supp-D-suppex.xpt.zip | November 1, 2022 | 6 KB | |
FDA-CBER-2021-5683-0593770-0593800-125742_S1_M5_bnt162-01-S-Supp-D-suppec.xpt.zip | November 1, 2022 | 7 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-2021-5683-0593665-0593743-125742_S1_M5_bnt162-01-S-Supp-D-suppcm.xpt.zip | November 1, 2022 | 19 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-2021-5683-0593596-0593620-125742_S1_M5_bnt162-01-S-D-se.xpt.zip | November 1, 2022 | 11 KB | |
FDA-CBER-2021-5683-0593482-0593595-125742_S1_M5_bnt162-01-S-D-pe.xpt.zip | November 1, 2022 | 42 KB | |
FDA-CBER-2021-5683-0593327-0593481-125742_S1_M5_bnt162-01-S-D-ce.xpt.zip | November 1, 2022 | 71 KB | |
FDA-CBER-2021-5683-0539816-0593326-125742_S1_M5_c4591001-01-S-Supp-D-face.xpt.zip | November 1, 2022 | 42 MB | |
125742_S1_M4_20256434.pdf.zip | November 1, 2022 | 20 MB | |
pd-production-110122.zip | November 1, 2022 | 71 MB | |
FDA CBER 2021 5683 0484461 0537913 125742_S1_M5_c4591001 S D face.zip (xpt) | October 3, 2022 | 52 MB | |
FDA CBER 2021 5683 0539337 0539815 125742_S1_M5_bnt162 01 A D advs.xpt | October 3, 2022 | 16 MB | |
FDA CBER 2021 5683 0537914 0539336 125742_S1_M5_bnt162 01 A D adfacevd.xpt | October 3, 2022 | 63 MB | |
FDA CBER 2021 5683 0484452 0484460 125742_S1_M5_bnt162 01 S D ti.xpt | October 3, 2022 | 84 KB | |
FDA CBER 2021 5683 0484442 0484451 125742_S1_M5_bnt162 01 S D ex.xpt | October 3, 2022 | 77 KB | |
FDA CBER 2021 5683 0484419 0484441 125742_S1_M5_bnt162 01 S D eg.xpt | October 3, 2022 | 300 KB | |
FDA CBER 2021 5683 0484409 0484418 125742_S1_M5_bnt162 01 S D ec.xpt | October 3, 2022 | 81 KB | |
FDA CBER 2021 5683 0484384 0484408 125742_S1_M5_bnt162 01 S D ds.xpt | October 3, 2022 | 171 KB | |
FDA CBER 2021 5683 0484379 0484383 125742_S1_M5_bnt162 01 S D dm.xpt | October 3, 2022 | 65 KB | |
FDA CBER 2021 5683 0484356 0484378 125742_S1_M5_bnt162 01 S D xa.xpt | October 3, 2022 | 502 KB | |
FDA CBER 2021 5683 0484342 0484355 125742_S1_M5_bnt162 01 S D ae.xpt | October 3, 2022 | 423 KB | |
pd-production-100322.zip | October 3, 2022 | 55 MB | |
22-00004-LT- Interim release.pdf | September 30, 2022 | 41 KB | |
consolidated_registrants[1].csv | September 30, 2022 | 503 MB | |
consolidated_health_checkin.csv | September 30, 2022 | 23 GB | |
Consolidated_health_checkin_u3[1].csv | September 30, 2022 | 19 MB | |
consolidated_vaccinations[1].zip | September 30, 2022 | 151 MB | |
consolidated_registrants[1].zip | September 30, 2022 | 125 MB | |
consolidated_race_ethnicity[1].zip | September 30, 2022 | 93 MB | |
Consolidated_health_checkin_u3[1].zip | September 30, 2022 | 4 MB | |
consolidated_health_checkin.zip | September 30, 2022 | 5 GB | |
Amended 22-01962-Pfizer-2022-0426-pulled 2022-0823.xlsx | September 16, 2022 | 36 MB | |
FDA-CBER-2021-5683-0396255-0484341_125742_S1_M5_c4591001-S-Supp-D-suppface.xpt | September 1, 2022 | 467 MB | |
pd-production-090122.zip | September 1, 2022 | 11 MB | |
FDA CBER 2021 5683 0396249 0396254_125742_S1_M5_bnt162 01 S D xb.xpt | September 1, 2022 | 43 KB | |
FDA CBER 2021 5683 0396247 0396248_125742_S1_M5_bnt162 01 S D ta.xpt | September 1, 2022 | 18 KB | |
FDA CBER 2021 5683 0396242 0396246_125742_S1_M5_bnt162 01 S D suppxa.xpt | September 1, 2022 | 24 KB | |
FDA CBER 2021 5683 0396239 0396241_125742_S1_M5_bnt162 01 S D suppeg.xpt | September 1, 2022 | 13 KB | |
FDA CBER 2021 5683 0396234 0396238_125742_S1_M5_bnt162 01 S D suppdv.xpt | September 1, 2022 | 56 KB | |
FDA CBER 2021 5683 0396228 0396233_125742_S1_M5_bnt162 01 S D rp.xpt | September 1, 2022 | 62 KB | |
FDA CBER 2021 5683 0396223 0396227_125742_S1_M5_bnt162 01 S D dv.xpt | September 1, 2022 | 67 KB | |
FDA CBER 2021 5683 0396214 0396222_125742_S1_M5_bnt162 01 S D cm.xpt | September 1, 2022 | 200 KB | |
FDA CBER 2021 5683 0396200 0396213_125742_S1_M5_bnt162 01 A D adae.xpt | September 1, 2022 | 804 KB | |
FDA-CBER-2021-5683-0396199_125742_S1_M5_bnt162-01-S-D-tv.zip | August 1, 2022 | 1 KB | |
FDA CBER 2021 5683 0396198_125742_S1_M5_bnt162 01 S D te.xpt | August 1, 2022 | 7 KB | |
FDA CBER 2021 5683 0396197_125742_S1_M5_bnt162 01 S D supprp.xpt | August 1, 2022 | 3 KB | |
FDA CBER 2021 5683 0396196_125742_S1_M5_bnt162 01 S D supppe.xpt | August 1, 2022 | 6 KB | |
FDA CBER 2021 5683 0396195_125742_S1_M5_bnt162 01 S D relrec.xpt | August 1, 2022 | 2 KB | |
FDA CBER 2021 5683 0396193 to 0396194_125742_S1_M5_c4591001 S D supppe.xpt | August 1, 2022 | 12 KB | |
FDA CBER 2021 5683 0396188 to 0396192_125742_S1_M5_c4591001 S D suppmo.xpt | August 1, 2022 | 65 KB | |
FDA CBER 2021 5683 0396187_125742_S1_M5_c4591001 S D pr.xpt | August 1, 2022 | 19 KB | |
FDA CBER 2021 5683 0396199_125742_S1_M5_bnt162 01 S D tv.xpt | August 1, 2022 | 4 KB | |
FDA-CBER-2021-5683-0308157 to -0396186_125742_S1_M5_c4591001-S-D-suppface.xpt | August 1, 2022 | 467 MB | |
125742_S2_M5_54_ezeanolue e 2019.pdf | August 1, 2022 | 40 MB | |
pd-production-080122.zip | August 1, 2022 | 48 MB | |
22-01272-Pfizer-Shipped-2022-0426.xlsx | July 25, 2022 | 15 MB | |
22-01271-Pfizer-2022-0426.xlsx | July 25, 2022 | 6 MB | |
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 | 6 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 | 151 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 | |
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 | 1 MB | |
FDA CBER 2021 5683 0286072 to 0286266_125742_S1_M5_c4591001 S Supp D relrec.zip (xpt) | July 1, 2022 | 54 KB | |
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 | |
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 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 | |
125742_S1_M5_5351_c4591001 interim mth6 protocol deviations.pdf | July 1, 2022 | 2 MB | |
125742_S1_M5_5351_c4591001 fa interim sap.pdf | July 1, 2022 | 3 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 | |
pd-production-070122.zip | July 1, 2022 | 199 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 | |
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 10151101.pdf | June 1, 2022 | 1 MB | |
125742_S1_M5_CRF_c4591001 1015 10151089.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 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 | |
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 1013 10131699.pdf | June 1, 2022 | 2 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 1015 10151047.pdf | June 1, 2022 | 1 MB | |
125742_S1_M5_CRF_c4591001 1013 10131517.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 10131255.pdf | June 1, 2022 | 1 MB | |
125742_S1_M5_CRF_c4591001 1013 10131229.pdf | June 1, 2022 | 1 MB | |
125742_S1_M5_CRF_c4591001 1013 10131190.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 10121163.pdf | June 1, 2022 | 2 MB | |
125742_S1_M5_CRF_c4591001 1013 10131554.pdf | June 1, 2022 | 2 MB | |
125742_S1_M5_CRF_c4591001 1012 10121097.pdf | June 1, 2022 | 2 MB | |
125742_S1_M5_CRF_c4591001 1011 10111181.pdf | June 1, 2022 | 1 MB | |
125742_S1_M5_CRF_c4591001 1011 10111029.pdf | June 1, 2022 | 2 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 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 1012 10121112.pdf | June 1, 2022 | 2 MB | |
125742_S1_M5_CRF_c4591001 1008 10081337.pdf | June 1, 2022 | 1 MB | |
125742_S1_M5_CRF_c4591001 1008 10081184.pdf | June 1, 2022 | 1 MB | |
125742_S1_M5_CRF_c4591001 1008 10081152.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 10071443.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 1008 10081603.pdf | June 1, 2022 | 1 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 MB | |
125742_S1_M5_CRF_c4591001 1007 10071124.pdf | June 1, 2022 | 2 MB | |
125742_S1_M5_CRF_c4591001 1007 10071117.pdf | June 1, 2022 | 2 MB | |
125742_S1_M5_CRF_c4591001 1007 10071101.pdf | June 1, 2022 | 1 MB | |
125742_S1_M5_CRF_c4591001 1007 10071097.pdf | June 1, 2022 | 2 MB | |
125742_S1_M5_CRF_c4591001 1007 10071050.pdf | June 1, 2022 | 3 MB | |
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 | |
pd-production-060122.zip | June 1, 2022 | 157 MB | |
pd-production-050222.zip | May 2, 2022 | 396 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 | |
125742_S1_M5_CRF_c4591001 1006 10061098.pdf | May 2, 2022 | 2 MB | |
125742_S1_M5_CRF_c4591001 1006 10061094.pdf | May 2, 2022 | 2 MB | |
125742_S1_M5_CRF_c4591001 1006 10061052.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 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 10051347.pdf | May 2, 2022 | 1 MB | |
125742_S1_M5_CRF_c4591001 1005 10051293.pdf | May 2, 2022 | 2 MB | |
125742_S1_M5_CRF_c4591001 1005 10051214.pdf | May 2, 2022 | 1 MB | |
125742_S1_M5_CRF_c4591001 1005 10051069.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 10051047.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 10031197.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_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 | |
pd-production-040122.zip | April 1, 2022 | 128 MB | |
pd-production-032422.zip | March 24, 2022 | 2 MB | |
125742_S1_M1_priority-review-request.pdf | March 24, 2022 | 2 MB | |
125742_S1_M1_priority-review-request.pdf | March 24, 2022 | 2 MB | |
cd-production-031622.zip | March 17, 2022 | 101 KB | |
034 – Transcript of Scheduling Conference (December 14, 2021).pdf | March 17, 2022 | 141 KB | |
FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsx | March 1, 2022 | 17 KB | |
FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx | March 1, 2022 | 12 KB | |
FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsx | March 1, 2022 | 10 KB | |
FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsx | March 1, 2022 | 10 KB | |
FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsx | March 1, 2022 | 9 KB | |
FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsx | March 1, 2022 | 9 KB | |
FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx | March 1, 2022 | 10 KB | |
FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsx | March 1, 2022 | 12 KB | |
FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx | March 1, 2022 | 35 KB | |
FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx | March 1, 2022 | 23 KB | |
FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx | March 1, 2022 | 84 KB | |
FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx | March 1, 2022 | 22 KB | |
FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx | March 1, 2022 | 19 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-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsx | March 1, 2022 | 29 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-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx | March 1, 2022 | 21 KB | |
FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsx | March 1, 2022 | 24 KB | |
FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx | March 1, 2022 | 11 KB | |
FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx | March 1, 2022 | 12 KB | |
FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx | March 1, 2022 | 12 KB | |
FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsx | March 1, 2022 | 9 KB | |
FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.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-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.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-2021-5683-0023455 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-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txt | March 1, 2022 | 29 KB | |
FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txt | March 1, 2022 | 75 KB | |
FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txt | March 1, 2022 | 75 KB | |
FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt | March 1, 2022 | 24 KB | |
FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt | March 1, 2022 | 49 KB | |
FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt | March 1, 2022 | 11 KB | |
FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt | March 1, 2022 | 45 KB | |
FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt | March 1, 2022 | 43 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-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txt | March 1, 2022 | 12 KB | |
FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txt | March 1, 2022 | 19 KB | |
FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txt | March 1, 2022 | 20 KB | |
FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txt | March 1, 2022 | 81 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-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txt | March 1, 2022 | 35 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-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txt | March 1, 2022 | 15 KB | |
FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txt | March 1, 2022 | 15 KB | |
FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txt | March 1, 2022 | 14 KB | |
FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txt | March 1, 2022 | 156 KB | |
FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt | March 1, 2022 | 32 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 | |
pd-production-030122.zip | March 1, 2022 | 195 MB | |
Order-February-7-2022.pdf | February 7, 2022 | 151 KB | |
cd-production-020722.zip | February 7, 2022 | 151 KB | |
056-ORDER-GRANTING-IN-PART-THE-MOTION-TO-MODIFY-THE-PRODUCTION-SCHEDULE-AND-ADDOPTS-THE-JOINT-STATUS-REPORT-MODIFIED-AGREED-PRODUCTION-SCHEDULE.pdf | February 2, 2022 | 124 KB | |
cd-production-020222.zip | February 2, 2022 | 125 KB | |
CRFs-for-site-1128.pdf | January 31, 2022 | 14 MB | |
pd-production-013122.zip | January 31, 2022 | 14 MB | |
047-PLAINTIFFS-RESPONSE-TO-PFIZER-INC.S-MOTION-FOR-LEAVE-TO-INTERVENE-FOR-A-LIMITED-PURPOSE.pdf | January 25, 2022 | 293 KB | |
046-RESPONSE-filed-by-Food-and-Drug-Administration-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdf | January 25, 2022 | 128 KB | |
cd-production-012522.zip | January 25, 2022 | 422 KB | |
044-PL-PHPMTS-MOL-IN-OPPOSITION-TO-DEFENDANTS-MOTION-TO-MODIFY-THE-SCHEDULING-ORDER-OF-THE-COURT.pdf | January 24, 2022 | 420 KB | |
cd-production-012422.zip | January 24, 2022 | 420 KB | |
041-Memorandum-in-Support-filed-by-Pfizer-Inc.-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdf | January 21, 2022 | 1,014 KB | |
cd-production-012122.zip | January 21, 2022 | 1,014 KB | |
CRFs-for-site-1096.pdf | January 18, 2022 | 11 MB | |
038-Appendix-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order.pdf | January 18, 2022 | 1 MB | |
037-Brief-Memorandum-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order-1.pdf | January 18, 2022 | 247 KB | |
pd-production-011822.zip | January 18, 2022 | 11 MB | |
cd-production-011822.zip | January 18, 2022 | 1 MB | |
ORDER_2022_01_06.pdf | January 6, 2022 | 169 KB | |
cd-production-010622.zip | January 6, 2022 | 170 KB | |
CRFs-for-site-1081.pdf | December 30, 2021 | 13 MB | |
pd-production-123021.zip | December 30, 2021 | 13 MB | |
Supplemental-Index-12-22-21.pdf | December 22, 2021 | 2 MB | |
pd-production-122221.zip | 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-2021-5683-0002380_ti.xpt | December 13, 2021 | 37 KB | |
BATES-FDA-CBER-2021-5683-0002379_te.xpt | December 13, 2021 | 3 KB | |
BATES-FDA-CBER-2021-5683-0002378_ta.xpt | December 13, 2021 | 8 KB | |
BATES-FDA-CBER-2021-5683-0002377_supppr.xpt | December 13, 2021 | 72 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-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt | December 13, 2021 | 9 KB | |
BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt | December 13, 2021 | 9 KB | |
BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt | December 13, 2021 | 9 KB | |
032-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-31-Reply.pdf | December 13, 2021 | 24 MB | |
031-REPLY-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-22-Brief-Memorandum-in-Support-of-Motion.pdf | December 13, 2021 | 175 KB | |
030-FDAs-Appendix-in-Support-of-Brief.pdf | December 13, 2021 | 1 MB | |
029-FDAs-Reply-re-Brief-in-Support-of-Motion.pdf | December 13, 2021 | 280 KB | |
pd-production-121321.zip | December 13, 2021 | 21 MB | |
cd-production-121321.zip | December 13, 2021 | 26 MB | |
027-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-26-Brief-Memorandum-in-Support-of-Motion.pdf | December 7, 2021 | 16 MB | |
026-Brief-Memorandum-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-21-Order-Setting-DeadlineHearing.pdf | December 7, 2021 | 239 KB | |
cd-production-120721.zip | December 7, 2021 | 17 MB | |
023-FDA-Appendix-in-Support-1.pdf | December 6, 2021 | 9 MB | |
022-FDA-Brief-in-Advance-of-Scheduling-Conference.pdf | December 6, 2021 | 273 KB | |
cd-production-120621.zip | December 6, 2021 | 9 MB | |
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 | |
pd-production-120121.zip | December 1, 2021 | 26 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 | |
pd-production-111721.zip | November 17, 2021 | 11 MB | |
111521-Second-Joint-Status-Report.pdf | November 15, 2021 | 382 KB | |
cd-production-111521.zip | November 15, 2021 | 382 KB | |
091621-Complaint.pdf | September 16, 2021 | 1 MB | |
cd-production-091621.zip | September 16, 2021 | 1 MB |