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Pfizer’s Documents

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File NameDate ProducedFile SizeLink
125742_S1_M5_CRF_c4591001 1254 12541142.pdfMay 1, 20232 MB
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125742_S1_M5_CRF_c4591001 1218 12181001.pdfMay 1, 20233 MB
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125742_S1_M5_CRF_c4591001 1254 12541189.pdfMay 1, 20231 MB
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125742_S1_M5_CRF_c4591001 1146 11461200.pdfMay 1, 20231 MB
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125742_S1_M5_CRF_c4591001 1146 11461015.pdfMay 1, 20232 MB
125742_S1_M5_CRF_c4591001 1145 11451076.pdfMay 1, 20231 MB
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125742_S1_M5_CRF_c4591001 1134 11341432.pdfMay 1, 20231 MB
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125742_S1_M5_CRF_c4591001 1150 11501153.pdfMay 1, 20231 MB
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125742_S1_M5_CRF_c4591001 1146 11461235.pdfMay 1, 20232 MB
125742_S1_M5_5314_vr tm 10293.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr sop lc 11120.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10083 att04.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10083 att03.pdfApril 3, 20231 MB
125742_S1_M5_5314_vr mvr 10083 att02.pdfApril 3, 20231 MB
125742_S1_M5_5314_vr mvr 10083 att01.pdfApril 3, 20231 MB
125742_S1_M5_5314_vr mvr 10083.pdfApril 3, 2023998 KB
125742_S1_M5_5314_vr mvr 10081 att 01.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10081.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10080 att 02.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10080 att 01.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10080.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10214 att 03.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10214 att 02.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10214 att 01.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10214.pdfApril 3, 20233 MB
125742_S1_M5_5314_vr mqr 10212 att 01.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10212.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10211 att 01.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10211.pdfApril 3, 20232 MB
125742_S14_M1_cover.pdfApril 3, 20232 MB
125742_S7_M5_5351_bnt162 01 interim3 reports.pdfApril 3, 202325 MB
125742_S4_M1_response 18 may 2021 datasets.pdfApril 3, 2023714 KB
125742_S4_M1_cover.pdfApril 3, 2023675 KB
125742_S3_M1_proprietary name.pdfApril 3, 20232 MB
125742_S3_M1_cover.pdfApril 3, 2023705 KB
125742_S2_M5_5354_wi255886 protocol.pdfApril 3, 20231 MB
125742_S2_M5_5354_c4591022 protocol.pdfApril 3, 20233 MB
125742_S2_M5_5354_c4591014 protocol.pdfApril 3, 20233 MB
125742_S2_M5_5354_c4591012 protocol.pdfApril 3, 202315 MB
125742_S2_M5_5354_c4591011 protocol.pdfApril 3, 20235 MB
125742_S2_M5_5354_c4591009 protocol synopsis.pdfApril 3, 20232 MB
125742_S2_M5_5354_c4591008 protocol.pdfApril 3, 20232 MB
125742_S2_M5_5351_c4591015 protocol amend2.pdfApril 3, 202313 MB
125742_S2_M5_5351_c4591007 protocol amend1.pdfApril 3, 202324 MB
125742_S2_M1_pllr waiver request pregnancy registry.pdfApril 3, 20232 MB
125742_S2_M1_pllr waiver request drug utilization.pdfApril 3, 20232 MB
125742_S2_M1_pllr lit search summary.pdfApril 3, 20232 MB
125742_S2_M1_pllr cumulative review.pdfApril 3, 20232 MB
125742_S2_M1_loa dmf 9543 vials.pdfApril 3, 2023609 KB
125742_S2_M1_diluent labeling proposal.pdfApril 3, 20232 MB
125742_S2_M1_dca vaed.pdfApril 3, 2023744 KB
125742_S2_M1_dca anaphylactic reaction.pdfApril 3, 2023724 KB
125742_S2_M1_cover.pdfApril 3, 2023697 KB
125742_S1_M5_5351_c4591001 interim mth6 synopsis.pdfApril 3, 20234 MB
125742_S1_M5_5351_c4591001 interim mth6 report body.pdfApril 3, 202318 MB
125742_S1_M5_5351_c4591001 fa interim synopsis.pdfApril 3, 20231 MB
125742_S1_M5_5351_c4591001 fa interim report body.pdfApril 3, 202329 MB
125742_S1_M5_5314_vr tm 10304.pdfApril 3, 20235 MB
125742_S1_M5_5314_vr tm 10298.pdfApril 3, 20233 MB
125742_S1_M5_5314_vr tm 10294.pdfApril 3, 20232 MB
FDA CBER 2021 5683 0770953 0770954_125742_S1_M4_20gr142 D_relrec.zip (xpt)March 1, 20231 KB
FDA CBER 2021 5683 0770914 0770952_125742_S1_M4_38166 D_relrec.zip (xpt)March 1, 20235 KB
FDA CBER 2021 5683 0770912 0770913_125742_S1_M4_20gr142 D_pooldef.zip (xpt)March 1, 20231 KB
FDA CBER 2021 5683 0770852 0770911_125742_S1_M4_20gr142 D_om.zip (xpt)March 1, 202348 KB
FDA CBER 2021 5683 0770669 0770851_125742_S1_M4_38166 D_om.zip (xpt)March 1, 2023120 KB
FDA CBER 2021 5683 0770591 0770668_125742_S1_M4_20gr142 D_mi.zip (xpt)March 1, 202344 KB
FDA CBER 2021 5683 0770196 0770590_125742_S1_M4_38166 D_mi.zip (xpt)March 1, 2023214 KB
FDA CBER 2021 5683 0770089 0770195_125742_S1_M4_20gr142 D_ma.zip (xpt)March 1, 202350 KB
FDA CBER 2021 5683 0769836 0770088_125742_S1_M4_38166 D_ma.zip (xpt)March 1, 202368 KB
FDA CBER 2021 5683 0769635 0769835_125742_S1_M4_20gr142 D_lb.zip (xpt)March 1, 2023212 KB
FDA CBER 2021 5683 0769068 0769634_125742_S1_M4_38166 D_lb.zip (xpt)March 1, 2023696 KB
FDA CBER 2021 5683 0769055 0769067_125742_S1_M4_20gr142 D_fw.zip (xpt)March 1, 202313 KB
FDA CBER 2021 5683 0769040 0769054_125742_S1_M4_38166 D_fw.zip (xpt)March 1, 202313 KB
FDA CBER 2021 5683 0769034 0769039_125742_S1_M4_20gr142 D_ex.zip (xpt)March 1, 20234 KB
FDA CBER 2021 5683 0769022 0769033_125742_S1_M4_38166 D_ex.zip (xpt)March 1, 20237 KB
FDA CBER 2021 5683 0769020 0769021_125742_S1_M4_20gr142 D_ds.zip (xpt)March 1, 20232 KB
FDA CBER 2021 5683 0769014 0769019_125742_S1_M4_38166 D_ds.zip (xpt)March 1, 20232 KB
FDA CBER 2021 5683 0769012 0769013_125742_S1_M4_20gr142 D_dm.zip (xpt)March 1, 20233 KB
FDA CBER 2021 5683 0769006 0769011_125742_S1_M4_38166 D_dm.zip (xpt)March 1, 20232 KB
FDA CBER 2021 5683 0769005_125742_S1_M4_20gr142 D_co.zip (xpt)March 1, 20232 KB
FDA CBER 2021 5683 0769003 0769004_125742_S1_M4_38166 D_co.zip (xpt)March 1, 20231 KB
FDA CBER 2021 5683 0768793 0769002_125742_S1_M4_20gr142 D_cl.zip (xpt)March 1, 2023151 KB
FDA CBER 2021 5683 0768324 0768792_125742_S1_M4_38166 D_cl.zip (xpt)March 1, 2023129 KB
FDA CBER 2021 5683 0768301 0768323_125742_S1_M4_20gr142 D_bw.zip (xpt)March 1, 202320 KB
FDA CBER 2021 5683 0768245 0768300_125742_S1_M4_38166 D_bw.zip (xpt)March 1, 202342 KB
FDA CBER 2021 5683 0768227 0768244_125742_S1_M4_20gr142 D_bg.zip (xpt)March 1, 202317 KB
FDA CBER 2021 5683 0768189 0768226_125742_S1_M4_38166 D_bg.zip (xpt)March 1, 202321 KB
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FDA CBER 2021 5683 0768093 0768158_125742_S1_M4_38166_define.zip (xml)March 1, 202328 KB
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FDA CBER 2021 5683 0767981 0768062_125742_S1_M4_20gr142_define.zip (xml)March 1, 202321 KB
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FDA CBER 2021 5683 0772117_125742_S1_M4_20gr142 D_ts.zip (xpt)March 1, 20232 KB
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FDA CBER 2021 5683 0770955 0770968_125742_S1_M4_38166 D_se.zip (xpt)March 1, 20233 KB
125742_S1_M4_20gr142_nsdrg.pdfMarch 1, 2023817 KB
125742_S1_M4_38166_nsdrg.pdfMarch 1, 2023856 KB
125742_S1_M4_4.2.3.2 38166.pdfMarch 1, 202321 MB
FDA-CBER-2021-5683-0772469-0773670_125742_S1_M5_C4591001-A-D_adsl.zip (xpt)March 1, 20237 MB
FDA-CBER-2021-5683-0773671-0774872_125742_S1_M5_C4591001-A-Supp-D-adsl.zip (xpt)March 1, 20237 MB
FDA-CBER-2021-5683-0774873-0775804_125742_S1_M5_C4591001-A-D_adae.zip (xpt)March 1, 20236 MB
FDA-CBER-2021-5683-0775805-0776791_125742_S1_M5_C4591001-S-D_ae.zip (xpt)March 1, 20232 MB
FDA-CBER-2021-5683-0776793-0777994_125742_S1_M5_C4591001-S-D_dm.zip (xpt)March 1, 20231 MB
FDA-CBER-2021-5683-0777995-0779196_125742_S1_M5_C4591001-S-Supp_dm.zip (xpt)March 1, 20231 MB
FDA-CBER-2021-5683-0764727-0765714-125742_S1_M5_c4591001-S-Supp-D-ae-supp.zip (xpt)February 1, 20232 MB
FDA-CBER-2021-5683-0764726-125742_S1_M5_c4591001-S-D-di.zip (xpt)February 1, 20232 KB
FDA-CBER-2021-5683-0763794-0764725-125742_S1_M5_c4591001-A-Supp-D-adae-supp.zip (xpt)February 1, 20236 MB
FDA-CBER-2021-5683-0710069-0763793-125742_S1_M5_c4591001-A-D-adc19ef.zip (xpt)February 1, 202333 MB
FDA-CBER-2021-5683-0710059-0710068-125742_S1_M5_bnt162-01-S-D-co.zip (xpt)February 1, 202313 KB
125742_S1_M4_4.2.2.1 vr vtr 10671.pdfFebruary 1, 20235 MB
125742_S1_M4_4.2.2 072424.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.1 vr vtr 10741.pdfFebruary 1, 20233 MB
125742_S1_M4_4.2.1 r 20 0211.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.1 r 20 0112.pdfFebruary 1, 20235 MB
125742_S1_M4_4.2.1 r 20 0085.pdfFebruary 1, 202323 MB
125742_S1_M2_2.6.7.1toxicology tabulated summary.pdfFebruary 1, 2023960 KB
125742_S1_M2_2.6.6 toxicology written summary.pdfFebruary 1, 20232 MB
125742_S1_M2_2.6.3.1 pharmacol tabulated summary.pdfFebruary 1, 20232 MB
125742_S1_M2_2.6.2 pharmacol written summary.pdfFebruary 1, 20237 MB
125742_S1_M2_2.6.1 introduction.pdfFebruary 1, 20232 MB
125742_S1_M4_4.3 munster jv 2020.pdfFebruary 1, 20233 MB
125742_S1_M4_4.2.3.2 20gr142.pdfFebruary 1, 202318 MB
125742_S1_M4_4.2.2.4 043725.pdfFebruary 1, 202312 MB
125742_S1_M4_4.2.2.4 01049 20022.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.2.4 01049 20021.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.2.4 01049 20020.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.2.4 01049 20010.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.2.4 01049 20009.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.2.4 01049 20008.pdfFebruary 1, 20231 MB
FDA CBER 2021 5683 0674998 0678267 125742_S1_M5_c4591001 S Supp D suppmb (xpt)January 3, 2023444 KB
FDA CBER 2021 5683 0671345 0674997 125742_S1_M5_c4591001 S D supplb (xpt)January 3, 2023522 KB
FDA CBER 2021 5683 0663135 0671344 125742_S1_M5_c4591001 A D adsympt (xpt)January 3, 20236 MB
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FDA CBER 2021 5683 0658060 0661613 125742_S1_M5_bnt162 01 S D face.xpt (xpt)January 3, 20232 MB
FDA CBER 2021 5683 0654507 0658059 125742_S1_M5_bnt162 01 S Supp D suppface (xpt)January 3, 2023612 KB
FDA CBER 2021 5683 0652981 0654506 125742_S1_M5_bnt162 01 A D adlb (xpt)January 3, 20233 MB
FDA CBER 2021 5683 0703843 0708840 125742_S1_M5_c4591001 S Supp D suppae (xpt)January 3, 2023895 KB
FDA CBER 2021 5683 0698920 0703842 125742_S1_M5_c4591001 S D suppae (xpt)January 3, 2023873 KB
FDA CBER 2021 5683 0681346 0688437 125742_S1_M5_c4591001 S D ds (xpt)January 3, 20233 MB
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FDA CBER 2021 5683 0652633 0652652 125742_S58_M1_lab 1448 0 5 annotated.docxJanuary 3, 2023523 KB
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FDA CBER 2021 5683 0652591 0652611 125742_S51_M1_lab 1448 0 4 annotated.docxJanuary 3, 2023539 KB
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FDA CBER 2021 5683 0652472 0652503 125742_S38_M5_c4591001 508 safety tables.docxJanuary 3, 202373 KB
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FDA CBER 2021 5683 0652548 0652569 125742_S39_M1_lab 1448 0 3 pkg insert clean.docxJanuary 3, 2023760 KB
FDA CBER 2021 5683 0652526 0652547 125742_S39_M1_lab 1448 0 3 annotated.docxJanuary 3, 20231 MB
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FDA CBER 2021 5683 0652920 0652940 125742_S76_M1_lab 1448 0 9 annotated.docxJanuary 3, 2023519 KB
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125742_S70_M1_lab 1448 0 7 pkg insert track.pdfJanuary 3, 20231 MB
125742_S70_M1_lab 1448 0 7 pkg insert clean.pdfJanuary 3, 20231 MB
125742_S70_M1_lab 1448 0 7 annotated.pdfJanuary 3, 20232 MB
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125742_S68_M1_lab 1448 0 6 pkg insert clean.pdfJanuary 3, 20231 MB
125742_S68_M1_lab 1448 0 6 annotated.pdfJanuary 3, 20233 MB
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125742_S79_M1_lab 1448 1 0 pkg insert clean.pdfJanuary 3, 2023875 KB
125742_S76_M1_lab 1448 0 9 pkg insert track.pdfJanuary 3, 20231 MB
125742_S76_M1_lab 1448 0 9 pkg insert clean.pdfJanuary 3, 20231 MB
125742_S76_M1_lab 1448 0 9 annotated.pdfJanuary 3, 20231 MB
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125742_S73_M1_lab 1448 0 8 pkg insert clean.pdfJanuary 3, 20231 MB
125742_S73_M1_lab 1448 0 8 annotated.pdfJanuary 3, 20233 MB
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125742_S64_M1_carton com195lkz kzoo.pdfJanuary 3, 2023135 KB
125742_S64_M1_carton com25ctpus puurs.pdfJanuary 3, 2023242 KB
125742_S64_M1_carton com25ctkz kzoo.pdfJanuary 3, 2023217 KB
125742_S58_M1_lab 1448 0 5 pkg insert track.pdfJanuary 3, 2023879 KB
125742_S58_M1_lab 1448 0 5 pkg insert clean.pdfJanuary 3, 2023878 KB
125742_S58_M1_lab 1448 0 5 annotated.pdfJanuary 3, 20233 MB
125742_S54_M1_carton com195lpus puurs.pdfJanuary 3, 2023179 KB
125742_S54_M1_carton com195lkz kzoo.pdfJanuary 3, 2023135 KB
125742_S54_M1_carton com25ctpus puurs.pdfJanuary 3, 2023691 KB
125742_S54_M1_carton com25ctkz kzoo.pdfJanuary 3, 2023218 KB
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125742_S51_M1_lab 1448 0 4 pkg insert track.pdfJanuary 3, 20231 MB
125742_S51_M1_lab 1448 0 4 pkg insert clean.pdfJanuary 3, 20231 MB
125742_S51_M1_lab 1448 0 4 annotated.pdfJanuary 3, 20234 MB
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125742_S64_M1_label comvlabkz kzoo.pdfJanuary 3, 202349 KB
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125742_S46_M1_carton com25ctpus puurs.pdfJanuary 3, 2023241 KB
125742_S46_M1_carton com25ctkz kzoo.pdfJanuary 3, 2023217 KB
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125742_S39_M1_lab 1448 0 3 annotated.pdfJanuary 3, 20236 MB
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125742_S29_M1_lab 1448 0 2 pkg insert track.pdfJanuary 3, 20231 MB
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125742_S29_M1_lab 1448 0 2 annotated.pdfJanuary 3, 20233 MB
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125742_S46_M1_label comvlabkz kzoo.pdfJanuary 3, 202349 KB
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125742_S27_M1_response 29jul2021.pdfJanuary 3, 20231 MB
125742_S21_M1_pvp track.pdfJanuary 3, 20238 MB
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125742_S16_M1_psp track.pdfJanuary 3, 2023922 KB
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125742_S12_M1_waiver req preservative.pdfJanuary 3, 2023710 KB
125742_S12_M1_13jul2021 response.pdfJanuary 3, 20231 MB
125742_S7_M1_response 08jun2021.pdfJanuary 3, 20231 MB
125742_S6_M5_5351_c4591001 sequencing listings.pdfJanuary 3, 20234 MB
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125742_S28_M1_response 22jul2021 followup.pdfJanuary 3, 2023767 KB
126_BLA 125742 0_08 23 2021_Memo_Other.pdfJanuary 3, 2023649 KB
114A_2_BLA_125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
106A_2_BLA_125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
98A_BLA_125742 0_08 19 2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
91A_2_BLA_125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
82A_BLA_125742 0_08 17 2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
78_BLA_125742 0_08 17 2021_Memo_Other.pdfJanuary 3, 2023814 KB
77_BLA_125742 0_08 17 2021_Memo_Lot Release Clearance.pdfJanuary 3, 2023805 KB
72A_BLA_125742 0_08 13 2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
36A_BLA_125742 0_07 28 2021_Telecon_Labeling Target Cl.pdfJanuary 3, 20231 MB
13_BLA_125742 0_07 02 2021_Committee Memo_APLB.pdfJanuary 3, 2023848 KB
10_BLA_125742 0_06 29 2021_Filing_Meeting_Summary.pdfJanuary 3, 2023713 KB
7_BLA_125742 0_06 17 2021_Memo_Other.pdfJanuary 3, 2023682 KB
4_BLA_125742 0_06 03 2021_First_Committee_Meeting_Summary.pdfJanuary 3, 2023772 KB
130_BLA _125742 0_09 01 2021_Committee Memo_Labeling.pdfJanuary 3, 2023771 KB
FDA CBER 2021 5683 0688438 0698919 125742_S1_M5_c4591001 S D vs (xpt)January 3, 20238 MB
FDA-CBER-2021-5683-0650114-0650115-125742_S1_M5_c4591001-S-D-ts.zip (xpt)December 1, 20224 KB
FDA-CBER-2021-5683-0634075-0650113-125742_S1_M5_c4591001-S-D-suppex.zip (xpt)December 1, 20223 MB
FDA-CBER-2021-5683-0633945-0634074-125742_S1_M5_bnt162-01-S-D-adva.zip (xpt)December 1, 2022169 KB
FDA-CBER-2021-5683-0633790-0633944-125742_S1_M5_bnt162-01-S-D-adcevd.zip (xpt)December 1, 2022133 KB
FDA-CBER-2021-5683-0623311-0633789-125742_S1_M5_c4591001-S-D-vs.zip (xpt)December 1, 20228.2 MB
FDA-CBER-2021-5683-0616659-0623310-125742_S1_M5_c4591001-S-D-sv.zip (xpt)December 1, 20222.5 MB
FDA-CBER-2021-5683-0600620-0616658-125742_S1_M5_c4591001-S-D-suppec.zip (xpt)December 1, 20223 MB
FDA-CBER-2021-5683-0595944-0600619-125742_S1_M5_c4591001-S-D-se.zip (xpt)December 1, 20222 MB
FDA-CBER-2021-5683-0595465-0595943-125742_S1_M5_bnt162-01-S-D-vs.zip (xpt)December 1, 2022391 KB
FDA-CBER-2021-5683-0594977-0595464-125742_S1_M5_bnt162-01-S-D-suppvs.zip (xpt)December 1, 202286 KB
FDA-CBER-2021-5683-0593801-0593831-125742_S1_M5_bnt162-01-S-Supp-D-suppex.zip (xpt)November 1, 20227 KB
FDA-CBER-2021-5683-0593770-0593800-125742_S1_M5_bnt162-01-S-Supp-D-suppec.zip (xpt)November 1, 20227 KB
FDA-CBER-2021-5683-0593744-0593769-125742_S1_M5_bnt162-01-S-Supp-D-suppds.zip (xpt)November 1, 20225 KB
FDA-CBER-2021-5683-0593665-0593743-125742_S1_M5_bnt162-01-S-Supp-D-suppcm.zip (xpt)November 1, 202221 KB
FDA-CBER-2021-5683-0593621-0593664-125742_S1_M5_bnt162-01-S-Supp-D-suppae.zip (xpt)November 1, 20226 KB
FDA-CBER-2021-5683-0593596-0593620-125742_S1_M5_bnt162-01-S-D-se.zip (xpt)November 1, 202212 KB
FDA-CBER-2021-5683-0593482-0593595-125742_S1_M5_bnt162-01-S-D-pe.zip (xpt)November 1, 202245 KB
FDA-CBER-2021-5683-0593327-0593481-125742_S1_M5_bnt162-01-S-D-ce.zip (xpt)November 1, 2022106 KB
FDA-CBER-2021-5683-0539816-0593326-125742_S1_M5_c4591001-01-S-Supp-D-face.zip (xpt)November 1, 202251 MB
125742_S1_M4_20256434.pdfNovember 1, 202222 MB
FDA-CBER-2021-5683-0539337-0539815-125742_S1_M5_bnt162-01-A-D-advs.zip (xpt)October 3, 2022862 KB
FDA-CBER-2021-5683-0537914-0539336-125742_S1_M5_bnt162-01-A-D-adfacevd.zip (xpt)October 3, 20222 MB
FDA-CBER-2021-5683-0484461-0537913-125742_S1_M5_c4591001-S-D-face.zip (xpt)October 3, 202252 MB
FDA-CBER-2021-5683-0484452-0484460-125742_S1_M5_bnt162-01-S-D-ti.zip (xpt)October 3, 20225 KB
FDA-CBER-2021-5683-0484442-0484451-125742_S1_M5_bnt162-01-S-D-ex.zip (xpt)October 3, 20227 KB
FDA-CBER-2021-5683-0484419-0484441-125742_S1_M5_bnt162-01-S-D-eg.zip (xpt)October 3, 202216 KB
FDA-CBER-2021-5683-0484409-0484418-125742_S1_M5_bnt162-01-S-D-ec.zip (xpt)October 3, 20226 KB
FDA-CBER-2021-5683-0484384-0484408-125742_S1_M5_bnt162-01-S-D-ds.zip (xpt)October 3, 202210 KB
FDA-CBER-2021-5683-0484379-0484383-125742_S1_M5_bnt162-01-S-D-dm.zip (xpt)October 3, 20227 KB
FDA-CBER-2021-5683-0484356-0484378-125742_S1_M5_bnt162-01-S-D-xa.zip (xpt)October 3, 202218 KB
FDA-CBER-2021-5683-0484342-0484355-125742_S1_M5_bnt162-01-S-D-ae.zip (xpt)October 3, 202233 KB
FDA-CBER-2021-5683-0396200-0396213_125742_S1_M5_bnt162-01-A-D-adae.zip (xpt)September 1, 202264 KB
FDA-CBER-2021-5683-0396214-0396222_125742_S1_M5_bnt162-01-S-D-cm.zip (xpt)September 1, 202215 KB
FDA-CBER-2021-5683-0396223-0396227_125742_S1_M5_bnt162-01-S-D-dv.zip (xpt)September 1, 20226 KB
FDA-CBER-2021-5683-0396228-0396233_125742_S1_M5_bnt162-01-S-D-rp.zip (xpt)September 1, 20224 KB
FDA-CBER-2021-5683-0396234-0396238_125742_S1_M5_bnt162-01-S-D-suppdv.zip (xpt)September 1, 20223 KB
FDA-CBER-2021-5683-0396239-0396241_125742_S1_M5_bnt162-01-S-D-suppeg.zip (xpt)September 1, 20221 KB
FDA-CBER-2021-5683-0396242-0396246_125742_S1_M5_bnt162-01-S-D-suppxa.zip (xpt)September 1, 20223 KB
FDA-CBER-2021-5683-0396247-0396248_125742_S1_M5_bnt162-01-S-D-ta.zip (xpt)September 1, 20222 KB
FDA-CBER-2021-5683-0396249-0396254_125742_S1_M5_bnt162-01-S-D-xb.zip (xpt)September 1, 20224 KB
FDA-CBER-2021-5683-0396255-0484341_125742_S1_M5_c4591001-S-Supp-D-suppface.zip (xpt)September 1, 202211 MB
FDA-CBER-2021-5683-0396199_125742_S1_M5_bnt162-01-S-D-tv.zip (xpt)August 1, 20221 KB
FDA-CBER-2021-5683-0396198_125742_S1_M5_bnt162-01-S-D-te.zip (xpt)August 1, 20221 KB
FDA-CBER-2021-5683-0396197_125742_S1_M5_bnt162-01-S-D-supprp.zip (xpt)August 1, 20221 KB
FDA-CBER-2021-5683-0396196_125742_S1_M5_bnt162-01-S-D-supppe.zip (xpt)August 1, 20221 KB
FDA-CBER-2021-5683-0396195_125742_S1_M5_bnt162-01-S-D-relrec.zip (xpt)August 1, 20221 KB
FDA-CBER-2021-5683-0396193 to -0396194_125742_S1_M5_c4591001-S-D-supppe.zip (xpt)August 1, 20221.4 KB
FDA-CBER-2021-5683-0396188 to -0396192_125742_S1_M5_c4591001-S-D-suppmo.zip (xpt)August 1, 20228.6 KB
FDA-CBER-2021-5683-0396187_125742_S1_M5_c4591001-S-D-pr.zip (xpt)August 1, 20222.7 KB
FDA-CBER-2021-5683-0308157 to -0396186_125742_S1_M5_c4591001-S-D-suppface.zip (xpt)August 1, 202211 MB
125742_S2_M5_54_ezeanolue-e-2019.pdfAugust 1, 202240 MB
FDA-CBER-2021-5683-0296904 to -0307543_125742_S1_M5_c4591001-S-D-suppce.zip (xpt)July 1, 20221 MB
FDA-CBER-2021-5683-0286267 to -0296903_125742_S1_M5_c4591001-S-Supp-D-suppce.zip (xpt)July 1, 20222 MB
FDA-CBER-2021-5683-0286072 to -0286266_125742_S1_M5_c4591001-S-Supp-D-relrec.zip (xpt)July 1, 202254 KB
FDA-CBER-2021-5683-0285652 to -0286071_125742_S1_M5_c4591001-S-D-pe.zip (xpt)July 1, 2022170 KB
FDA-CBER-2021-5683-0285644 to -0285651_125742_S1_M5_c4591001-S-D-mo.zip (xpt)July 1, 20228 KB
FDA-CBER-2021-5683-0282366 to -0285643_125742_S1_M5_c4591001-S-D-mb.zip (xpt)July 1, 20222 MB
FDA-CBER-2021-5683-0282329 to -0282365_125742_S1_M5_c4591001-S-D-ie.zip (xpt)July 1, 202219 KB
FDA-CBER-2021-5683-0282130 to -0282328_125742_S1_M5_c4591001-S-D-cm.zip (xpt)July 1, 2022152 KB
FDA-CBER-2021-5683-0225598 to -0282129_125742_S1_M5_c4591001-A-Supp-D-adfacevd.zip (xpt)July 1, 202284 MB
FDA-CBER-2021-5683-0225100 to -0225597_125742_S1_M5_c4591001-A-D-adcm.zip (xpt)July 1, 20221 MB
125742_S2_M1_comvlabp vial puurs.pdfJuly 1, 2022648 KB
125742_S2_M1_com195lpus carton puurs.pdfJuly 1, 2022691 KB
125742_S2_M1_comvlabkz vial kzoo.pdfJuly 1, 2022863 KB
125742_S2_M1_com25ctpus carton puurs.pdfJuly 1, 2022672 KB
125742_S2_M1_com195lkz carton kzoo.pdfJuly 1, 20221,024 KB
125742_S2_M1_com25ctkz carton kzoo.pdfJuly 1, 2022632 KB
125742_S1_M5_5351_c4591001 interim mth6 sap.pdfJuly 1, 20225 MB
125742_S1_M5_5351_c4591001 interim mth6 protocol deviations.pdfJuly 1, 20222 MB
125742_S1_M5_5351_c4591001 interim mth6 lab measurements sensitive.pdfJuly 1, 20225 MB
125742_S1_M5_5351_c4591001 interim mth6 excluded patients sensitive.pdfJuly 1, 20223 MB
125742_S1_M5_5351_c4591001 interim mth6 excluded patients.pdfJuly 1, 20221 MB
125742_S1_M5_5351_c4591001 interim mth6 errata.pdfJuly 1, 20222 MB
125742_S1_M5_5351_c4591001 interim mth6 efficacy response.pdfJuly 1, 20221 MB
125742_S1_M5_5351_c4591001 interim mth6 discontinued patients.pdfJuly 1, 20224 MB
125742_S1_M5_5351_c4591001 fa interim sap.pdfJuly 1, 20223 MB
125742_S1_M5_5351_c4591001 interim mth6 compliance sensitive.pdfJuly 1, 20221 MB
125742_S2_M1_right of reference.pdfJuly 1, 20222 MB
125742_S2_M1_loa dmf 031786 vials.pdfJuly 1, 20222 MB
125742_S2_M1_loa dmf 012683 vials.pdfJuly 1, 2022631 KB
125742_S2_M1_loa dmf 011820 vials.pdfJuly 1, 2022616 KB
125742_S2_M1_loa dmf 011793 vials.pdfJuly 1, 2022701 KB
125742_S2_M1_loa dmf 011321 vials.pdfJuly 1, 20221,019 KB
125742_S2_M1_hospira diluent label.pdfJuly 1, 2022776 KB
125742_S2_M1_loa dmf 10953 stopper.pdfJuly 1, 2022861 KB
125742_S2_M1_hospira diluent carton.pdfJuly 1, 2022987 KB
125742_S2_M1_fk diluent stamp.pdfJuly 1, 2022598 KB
125742_S2_M1_fk diluent carton.pdfJuly 1, 2022607 KB
125742_S2_M5_5354_wi235284-protocol.pdfJuly 1, 202216 MB
125742_S1_M5_5351_c4591001-interim-mth6-interlab-standard.pdfJuly 1, 202211 MB
125742_S1_M5_5351_c4591001-fa-interim-narrative-sensitive.pdfJuly 1, 202219 MB
125742_S1_M5_5351_c4591001-interim-mth6-adverse-events.zip (pdf)July 1, 202228 MB
FDA-CBER-2021-5683-0208521 to -0216666_125742_S1_M5_c4591001-S-Supp-D-suppvs.zip (xpt)June 1, 2022917 KB
FDA-CBER-2021-5683-0205318 to -0208520_125742_S1_M5_c4591001-S-Supp-D-ex.zip (xpt)June 1, 20222 MB
FDA-CBER-2021-5683-0196049 to -0205317_125742_S1_M5_c4591001-S-Supp-D-ce.zip (xpt)June 1, 20228 MB
FDA-CBER-2021-5683-0187906 to -0196048_125742_S1_M5_c4591001-S-D-suppvs.zip (xpt)June 1, 2022915 KB
FDA-CBER-2021-5683-0182981 to -0187905_125742_S1_M5_c4591001-S-D-suppmh.zip (xpt)June 1, 2022616 KB
FDA-CBER-2021-5683-0180191 to -0182980_125742_S1_M5_c4591001-S-D-suppis.zip (xpt)June 1, 2022350 KB
FDA-CBER-2021-5683-0178319 to -0180190_125742_S1_M5_c4591001-S-D-suppho.zip (xpt)June 1, 2022259 KB
FDA-CBER-2021-5683-0174607 to -0178318_125742_S1_M5_c4591001-S-D-suppdv.zip (xpt)June 1, 2022623 KB
FDA-CBER-2021-5683-0171524 to -0174606_125742_S1_M5_c4591001-S-D-suppds.zip (xpt)June 1, 2022405 KB
FDA-CBER-2021-5683-0169082 to -0171523_125742_S1_M5_c4591001-S-D-suppdm.zip (xpt)June 1, 2022334 KB
FDA-CBER-2021-5683-0168683 to -0169081_125742_S1_M5_c4591001-S-D-suppcm.zip (xpt)June 1, 202271 KB
FDA-CBER-2021-5683-0165893 to -0168682_125742_S1_M5_c4591001-S-D-is.zip (xpt)June 1, 20221 MB
FDA-CBER-2021-5683-0162690 to -0165892_125742_S1_M5_c4591001-S-D-ex.zip (xpt)June 1, 20222 MB
FDA-CBER-2021-5683-0159487 to -0162689_125742_S1_M5_c4591001-S-D-ec.zip (xpt)June 1, 20222 MB
FDA-CBER-2021-5683-0158560 to -0159486_125742_S1_M5_c4591001-S-D-dv.zip (xpt)June 1, 2022558 KB
FDA-CBER-2021-5683-0149082 to -0158559_125742_S1_M5_c4591001-S-D-ce.zip (xpt)June 1, 20228 MB
FDA-CBER-2021-5683-0142307 to -0149081_125742_S1_M5_c4591001-A-Supp-D-adcevd.zip (xpt)June 1, 20228 MB
125742_S1_M5_CRF_c4591001 1081 10811194 reissue.pdfJune 1, 20222 MB
125742_S1_M5_CRF_c4591001 1015 10151238.pdfJune 1, 20223 MB
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STN 125742 0 0 Section 2.5 Clinical Overview reissue.pdfJune 1, 20225 MB
125742_S1_M5_CRF_c4591001 1128 11281009 reissue.pdfJune 1, 20222 MB
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125742_S1_M5_5351_c4591001 interim mth6 publications.pdfJune 1, 202211 MB
125742_S1_M5_5351_c4591001 interim mth6 patient batches.pdfJune 1, 20221 MB
125742_S1_M5_5351_c4591001 fa interim protocol deviations sensitive.pdfJune 1, 20222 MB
125742_S1_M5_5351_c4591001 fa interim discontinued patients.pdfJune 1, 20223 MB
125742_S1_M5_5351_c4591001 fa interim patient batches.pdfJune 1, 20221 MB
125742_S1_M5_5351_c4591001 fa interim adverse events.pdfJune 1, 202232 MB
125742_S1_M5_5314_shi sop 10011.pdfJune 1, 20222 MB
125742_S1_M2_summary biopharm.pdfJune 1, 20222 MB
125742_S1_M5_5351_c4591001 interim mth6 randomization.pdfJune 1, 20221 MB
FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.zip (.xpt)May 2, 20227 MB
FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.zip (.xpt)May 2, 202281 MB
FDA-CBER-2021-5683-0059000 to -0065773_125742_S1_M5_c4591001-A-D-adcevd.zip (.xpt)May 2, 20229 MB
FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xptMay 2, 202244 MB
FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xslMay 2, 2022183 KB
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FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xmlMay 2, 2022692 KB
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125742_S1_M5_CRF_c4591001 1003 10031065.pdfMay 2, 20223 MB
125742_S1_M5_bnt162 01 S acrf.pdfMay 2, 20221 MB
125742_S1_M5_bnt162 01 A adrg.pdfMay 2, 2022891 KB
125742_S1_M5_c4591001 S csdrg.pdfMay 2, 20221 MB
125742_S1_M5_c4591001 S Supp acrf.pdfMay 2, 20223 MB
125742_S1_M5_c4591001 S acrf.pdfMay 2, 20223 MB
125742_S1_M5_bnt162 01 S csdrg.pdfMay 2, 20221 MB
125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdfMay 2, 202212 MB
125742_S1_M5_5351_c4591001 interim mth6 sample crf.pdfMay 2, 20225 MB
125742_S1_M5_5351_c4591001 interim mth6 randomization sensitive.pdfMay 2, 202265 MB
125742_S1_M5_5351_bnt162 01 interim3 sample crf.pdfMay 2, 20229 MB
125742_S1_M5_5351_bnt162 01 interim3 report body.pdfMay 2, 202242 MB
125742_S1_M5_5351_bnt162 01 interim3 protocol deviations.pdfMay 2, 20221 MB
125742_S1_M5_5351_bnt162 01 interim3 protocol.pdfMay 2, 202210 MB
125742_S1_M5_5351_bnt162 01 interim3 patient batches.pdfMay 2, 20223 MB
125742_S1_M5_5351_bnt162 01 interim3 notes for reader.pdfMay 2, 20221 MB
125742_S1_M5_5351_bnt162 01 interim3 synopsis.pdfMay 2, 20224 MB
125742_S1_M5_5351_bnt162 01 interim3 sponsor signature.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01 interim3 sap.pdfMay 2, 20223 MB
125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdfMay 2, 202291 MB
125742_S1_M5_5351_bnt162 01 interim3 discontinued patients.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01 interim3 demographics.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01 interim3 compliance.pdfMay 2, 20227 MB
125742_S1_M5_5351_bnt162 01 interim3 adverse events.pdfMay 2, 20227 MB
125742_S1_M5_5351_bnt162 01 interim3 investigators.pdfMay 2, 20226 MB
125742_S1_M5_5351_bnt162 01 interim3 invest signature.pdfMay 2, 2022634 KB
125742_S1_M5_5351_bnt162 01 interim3 iec irb.pdfMay 2, 20221 MB
125742_S1_M5_5351_bnt162 01 interim3 excluded patients.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01_10075.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01_10010.pdfMay 2, 20221 MB
125742_S1_M5_5351_bnt162 01_20215.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01_20242.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01_20116.pdfMay 2, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdfApril 1, 20228 MB
125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdfApril 1, 2022677 KB
125742_S1_M5_5351_c4591001-fa-interim-demographics.pdfApril 1, 202228 MB
125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdfApril 1, 2022869 KB
125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdfApril 1, 20221 MB
reissue_5.3.6 postmarketing experience.pdfApril 1, 2022958 KB
125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdfApril 1, 202228 MB
125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdfApril 1, 20222 MB
125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdfApril 1, 20225 MB
125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdfApril 1, 202259 MB
125742_S1_M5_5351_c4591001-fa-interim-randomization.pdfApril 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-publications.pdfApril 1, 202210 MB
125742_S1_M1_priority-review-request.pdfMarch 24, 20222 MB
FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsxMarch 1, 202223 KB
FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsxMarch 1, 202235 KB
FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsxMarch 1, 202222 KB
FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsxMarch 1, 202284 KB
FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsxMarch 1, 202229 KB
FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsxMarch 1, 202218 KB
FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsxMarch 1, 202219 KB
FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsxMarch 1, 202211 KB
FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsxMarch 1, 202224 KB
FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsxMarch 1, 202221 KB
FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsxMarch 1, 202214 KB
FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsxMarch 1, 202217 KB
FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xslMarch 1, 2022183 KB
FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsxMarch 1, 202213 KB
FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsxMarch 1, 202213 KB
FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txtMarch 1, 202275 KB
FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txtMarch 1, 202243 KB
FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txtMarch 1, 202245 KB
FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txtMarch 1, 202275 KB
FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txtMarch 1, 2022197 KB
FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txtMarch 1, 202275 KB
FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txtMarch 1, 202229 KB
FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txtMarch 1, 202227 KB
FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txtMarch 1, 202272 KB
FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txtMarch 1, 2022193 KB
FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txtMarch 1, 202224 KB
FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txtMarch 1, 202219 KB
FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txtMarch 1, 202212 KB
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FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txtMarch 1, 202249 KB
FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txtMarch 1, 202232 KB
FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txtMarch 1, 2022156 KB
125742_S1_M5_CRF_c4591001-1085-10851216March 1, 20221 MB
FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sasMarch 1, 202281 KB
FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sasMarch 1, 202220 KB
FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sasMarch 1, 202215 KB
FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sasMarch 1, 202235 KB
FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sasMarch 1, 202218 KB
FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sasMarch 1, 202215 KB
FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sasMarch 1, 202215 KB
125742_S1_M5_CRF_c4591001-1085-10851246.pdfMarch 1, 20221 MB
FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txtMarch 1, 202214 KB
125742_S1_M5_c4591001-T-S-roadmap.pdfMarch 1, 2022703 KB
125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-A-report-cci-renal.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-report-cci-rheumatic.pdfMarch 1, 2022629 KB
125742_S1_M5_CRF_c4591001-1085-10851129.pdfMarch 1, 20222 MB
125742_S1_M5_CRF_c4591001-1085-10851018.pdfMarch 1, 20222 MB
125742_S1_M5_CRF_c4591001-1085-10851116.pdfMarch 1, 20221 MB
125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdfMarch 1, 202217 MB
125742_S1_M5_c4591001-T-S-suppl-arg.pdfMarch 1, 2022738 KB
125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdfMarch 1, 2022667 KB
125742_S1_M5_c4591001-A-report-cci-lymphoma.pdfMarch 1, 2022640 KB
125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdfMarch 1, 2022626 KB
125742_S1_M5_c4591001-A-report-cci-leukemia.pdfMarch 1, 2022631 KB
125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdfMarch 1, 2022632 KB
125742_S1_M5_c4591001-A-report-cci-pulmonary.pdfMarch 1, 2022630 KB
125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdfMarch 1, 2022625 KB
125742_S1_M5_c4591001-A-report-cci-mild-liver.pdfMarch 1, 2022628 KB
125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdfMarch 1, 2022626 KB
125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdfMarch 1, 2022636 KB
125742_S1_M5_c4591001-A-report-cci-mi.pdfMarch 1, 2022624 KB
125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdfMarch 1, 2022670 KB
125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdfMarch 1, 2022846 KB
125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdfMarch 1, 2022607 KB
125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdfMarch 1, 2022627 KB
125742_S1_M5_c4591001-A-comorbidity-categories.pdfMarch 1, 2022637 KB
125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdfMarch 1, 2022626 KB
125742_S1_M5_c4591001-A-report-cci-chf.pdfMarch 1, 2022628 KB
125742_S1_M5_c4591001-A-report-cci-dementia.pdfMarch 1, 2022626 KB
125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdfMarch 1, 2022632 KB
125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdfMarch 1, 20225 MB
125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdfMarch 1, 2022620 KB
125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdfMarch 1, 2022634 KB
125742_S1_M5_c4591001-A-adrg.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-A-bmi-12-15-scale.pdfMarch 1, 2022627 KB
125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdfMarch 1, 202237 MB
125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdfMarch 1, 2022602 KB
125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdfMarch 1, 202213 MB
125742_S1_M5_5351_c4591001-fa-interim-protocol.pdfMarch 1, 202231 MB
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-errata.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdfMarch 1, 20221 MB
125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdfMarch 1, 2022889 KB
125742_S1_M5_5351_c4591001-fa-interim-compliance.pdfMarch 1, 20222 MB
125742_S1_M4_4223_R-20-0072.pdfMarch 1, 20225 MB
125742_S1_M4_4223_185350.pdfMarch 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdfMarch 1, 202212 MB
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdfMarch 1, 202216 MB
125742_S1_M2_26_pharmkin-written-summary.pdfMarch 1, 20221 MB
125742_S1_M2_24_nonclinical-overview.pdfMarch 1, 20222 MB
125742_S1_M2_26_pharmkin-tabulated-summary.pdfMarch 1, 20221 MB
125742_S1_M2_22_introduction.pdfMarch 1, 2022670 KB
125742_S1_M1_waiver-req-designated-suffix.pdfMarch 1, 20223 MB
125742_S1_M1_us-agent-authorization.pdfMarch 1, 20221 MB
125742_S1_M1_userfee.pdfMarch 1, 2022628 KB
125742_S1_M2_27_synopses-indiv-studies.pdfMarch 1, 20222 MB
125742_S1_M1_trans-of-oblig.pdfMarch 1, 2022717 KB
125742_S1_M2_27_literature-references.pdfMarch 1, 20222 MB
125742_S1_M1_ipsp-agreed-letter.pdfMarch 1, 2022658 KB
125742_S1_M1_financial-cert-3454.pdfMarch 1, 20223 MB
125742_S1_M1_financial-cert-bias.pdfMarch 1, 2022696 KB
125742_S1_M1_fast-track-designation.pdfMarch 1, 2022649 KB
125742_S1_M1_exclusivity-claim.pdfMarch 1, 2022616 KB
125742_S1_M1_cover.pdfMarch 1, 20221 MB
125742_S1_M1_debarment.pdfMarch 1, 2022656 KB
125742_S1_M1_3674.pdfMarch 1, 20225 MB
125742_S1_M1_356h.pdfMarch 1, 2022714 KB
125742_S1_M1_priority-review-request.pdfMarch 1, 20222 MB
CRFs for site 1128.pdfJanuary 31, 202214 MB
CRFs for site 1096.pdfJanuary 18, 202211 MB
CRFs for site 1081.pdfDecember 30, 202113 MB
Supplemental Index 12-22-21.pdfDecember 22, 20212 MB
STN 125742_0_0 Section 2.7.4 summary-clin-safety.pdfDecember 13, 20216 MB
STN 125742_0_0 Section 2.7.3 Summary of Clinical Efficacy.pdfDecember 13, 20213 MB
STN 125742_0_0 Section 2.5 Clinical Overview.pdfDecember 13, 20214 MB
CRFs for site 1055.pdfDecember 13, 20216 MB
BATES-FDA-CBER-2021-5683-0002376_relrec.xptDecember 13, 2021567 KB
BATES-FDA-CBER-2021-5683-0002380_ti.xptDecember 13, 202137 KB
BATES-FDA-CBER-2021-5683-0002379_te.xptDecember 13, 20213 KB
BATES-FDA-CBER-2021-5683-0002378_ta.xptDecember 13, 20218 KB
signed F21-5683 CBER Dec 13 2021 Response Letter.pdfDecember 13, 2021207 KB
BATES-FDA-CBER-2021-5683-0002377_supppr.xptDecember 13, 202172 KB
BATES-FDA-CBER-2021-5683-0002375_addv-sas.txtDecember 13, 20215 KB
BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
Pages 42-289-Section 5.2 – listing-clinical-sites-cvs_Part B.pdfDecember 1, 202114 MB
Pages 42-289-Section 5.2 – listing-clinical-sites-cvs_Part A.pdfDecember 1, 202112 MB
5.2 listing of clinical sites and cvs pages 1-41.pdfNovember 17, 20218 MB
5.2 tabular listing.pdfNovember 17, 20212 MB
5.3.6 postmarketing experience.pdfNovember 17, 2021984 KB
BATES-93_tv.xptNovember 17, 202116 KB
BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txtNovember 17, 20219 KB