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| 125742_S1_M1_trans-of-oblig.pdf | 717.14 KB | ||
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| 125742_S1_M2_22_introduction.pdf | 670.17 KB | ||
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| 125742_S1_M4_4223_R-20-0072.pdf | 5.21 MB | ||
| 125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdf | 889.15 KB | ||
| 125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdf | 1.26 MB | ||
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| 125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdf | 2.39 MB | ||
| 125742_S1_M5_5351_c4591001-fa-interim-errata.pdf | 2.27 MB | ||
| 125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf | 15.7 MB | ||
| 125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdf | 1.81 MB | ||
| 125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdf | 4.78 MB | ||
| 125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdf | 12.02 MB | ||
| 125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdf | 2.29 MB | ||
| 125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf | 31.31 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdf | 13 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf | 36.94 MB | ||
| 125742_S1_M5_CRF_c4591001-1085-10851018.pdf | 2.25 MB | ||
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| 125742_S1_M5_CRF_c4591001-1085-10851246.pdf | 1.14 MB | ||
| 125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdf | 602.23 KB | ||
| 125742_S1_M5_c4591001-A-adrg.pdf | 1.54 MB | ||
| 125742_S1_M5_c4591001-A-bmi-12-15-scale.pdf | 627.05 KB | ||
| 125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdf | 634.25 KB | ||
| 125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdf | 620.2 KB | ||
| 125742_S1_M5_c4591001-A-comorbidity-categories.pdf | 636.9 KB | ||
| 125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdf | 606.89 KB | ||
| 125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdf | 846.03 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdf | 629.08 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdf | 670.23 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdf | 631.62 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-chf.pdf | 628.18 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-dementia.pdf | 625.82 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdf | 625.67 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdf | 626.79 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdf | 625.58 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-leukemia.pdf | 631.44 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-lymphoma.pdf | 640.12 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdf | 635.64 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-mi.pdf | 624.25 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-mild-liver.pdf | 628.36 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdf | 625.68 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdf | 624.81 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdf | 631.6 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-pulmonary.pdf | 629.63 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-renal.pdf | 628.94 KB | ||
| 125742_S1_M5_c4591001-A-report-cci-rheumatic.pdf | 629.4 KB | ||
| 125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdf | 2.22 MB | ||
| 125742_S1_M5_c4591001-T-S-roadmap.pdf | 702.77 KB | ||
| 125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdf | 666.79 KB | ||
| 125742_S1_M5_c4591001-T-S-suppl-arg.pdf | 738.13 KB | ||
| 125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdf | 17.43 MB | ||
| FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txt | 13.87 KB | ||
| FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txt | 14.67 KB | ||
| FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txt | 14.75 KB | ||
| FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txt | 15.11 KB | ||
| FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txt | 35.46 KB | ||
| FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txt | 17.94 KB | ||
| FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txt | 81.06 KB | ||
| FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txt | 19.55 KB | ||
| FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txt | 19.46 KB | ||
| FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txt | 12.27 KB | ||
| FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txt | 71.56 KB | ||
| FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txt | 192.86 KB | ||
| FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txt | 27.11 KB | ||
| FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt | 32.19 KB | ||
| FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txt | 155.76 KB | ||
| FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt | 11.04 KB | ||
| FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt | 48.94 KB | ||
| FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt | 24.03 KB | ||
| FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txt | 74.64 KB | ||
| FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txt | 74.71 KB | ||
| FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txt | 29.2 KB | ||
| FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txt | 75.39 KB | ||
| FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txt | 197.17 KB | ||
| FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt | 43.24 KB | ||
| FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt | 44.8 KB | ||
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| FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx | 12.98 KB | ||
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| FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx | 18.48 KB | ||
| FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx | 18.86 KB | ||
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| FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx | 84.13 KB | ||
| FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx | 22.73 KB | ||
| FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx | 34.78 KB | ||
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| FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx | 10.25 KB | ||
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| FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx | 11.67 KB | ||
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| FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx | 11.71 KB | ||
| FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx | 11.55 KB | ||
| FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx | 11.09 KB | ||
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| FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx | 21.34 KB | ||
| pd-production-032422 | |||
| 125742_S1_M1_priority-review-request.pdf | 2.37 MB | ||
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| 125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdf | 869.17 KB | ||
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| reissue_5.3.6 postmarketing experience.pdf | 957.62 KB | ||
| pd-production-050222 | |||
| 125742_S1_M5_5351_bnt162-01-interim3-adverse-events.pdf | 7.08 MB | ||
| 125742_S1_M5_5351_bnt162-01-interim3-compliance.pdf | 7.44 MB | ||
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| FDA-CBER-2021-5683-0058316 to -0058458_125742_S1_M5_c4591001-A-Supp-define.xml | 691.95 KB | ||
| FDA-CBER-2021-5683-0058459 to -0058478_125742_S1_M5_c4591001-A-Supp-define-2-0-0.xsl | 183.26 KB | ||
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| FDA-CBER-2021-5683-0058595 to -0058614_125742_S1_M5_c4591001-S-define-2-0-0.xsl | 183.26 KB | ||
| FDA-CBER-2021-5683-0058615 to -0058652_125742_S1_M5_c4591001-S-Supp-define.xml | 299.8 KB | ||
| FDA-CBER-2021-5683-0058653 to -0058675_125742_S1_M5_c4591001-S-Supp-define-2-0-0.xsl | 183.26 KB | ||
| FDA-CBER-2021-5683-0058676 to -0058794_125742_S1_M5_bnt162-01-A-define.xml | 828.13 KB | ||
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| FDA-CBER-2021-5683-0059000 to -0065773_125742_S1_M5_c4591001-A-D-adcevd.xpt | 394.37 MB | ||
| FDA-CBER-2021-5683-0065774 to -0066700_125742_S1_M5_c4591001-A-D-addv.xpt | 43.54 MB | ||
| FDA-CBER-2021-5683-0066701 to -0123167_125742_S1_M5_c4591001-A-D-adfacevd.xpt | 3.85 GB | ||
| FDA-CBER-2021-5683-0123168 to -0126026_125742_S1_M5_c4591001-A-D-adva.xpt | 162.85 MB | ||
| pd-production-060122 | |||
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| 125742_S1_M5_CRF_c4591001-1128-11281009 reissue.pdf | 1.88 MB | ||
| FDA-CBER-2021-5683-0142307 to -0149081_125742_S1_M5_c4591001-A-Supp-D-adcevd.xpt | 425.98 MB | ||
| FDA-CBER-2021-5683-0149082 to -0158559_125742_S1_M5_c4591001-S-D-ce.xpt | 368.08 MB | ||
| FDA-CBER-2021-5683-0158560 to -0159486_125742_S1_M5_c4591001-S-D-dv.xpt | 11.43 MB | ||
| FDA-CBER-2021-5683-0159487 to -0162689_125742_S1_M5_c4591001-S-D-ec.xpt | 46.56 MB | ||
| FDA-CBER-2021-5683-0162690 to -0165892_125742_S1_M5_c4591001-S-D-ex.xpt | 44.73 MB | ||
| FDA-CBER-2021-5683-0165893 to -0168682_125742_S1_M5_c4591001-S-D-is.xpt | 29.38 MB | ||
| FDA-CBER-2021-5683-0168683 to -0169081_125742_S1_M5_c4591001-S-D-suppcm.xpt | 2.75 MB | ||
| FDA-CBER-2021-5683-0169082 to -0171523_125742_S1_M5_c4591001-S-D-suppdm.xpt | 13.7 MB | ||
| FDA-CBER-2021-5683-0171524 to -0174606_125742_S1_M5_c4591001-S-D-suppds.xpt | 16.94 MB | ||
| FDA-CBER-2021-5683-0174607 to -0178318_125742_S1_M5_c4591001-S-D-suppdv.xpt | 23.37 MB | ||
| FDA-CBER-2021-5683-0178319 to -0180190_125742_S1_M5_c4591001-S-D-suppho.xpt | 8.22 MB | ||
| FDA-CBER-2021-5683-0180191 to -0182980_125742_S1_M5_c4591001-S-D-suppis.xpt | 7.99 MB | ||
| FDA-CBER-2021-5683-0182981 to -0187905_125742_S1_M5_c4591001-S-D-suppmh.xpt | 21.61 MB | ||
| FDA-CBER-2021-5683-0187906 to -0196048_125742_S1_M5_c4591001-S-D-suppvs.xpt | 39.15 MB | ||
| FDA-CBER-2021-5683-0196049 to -0205317_125742_S1_M5_c4591001-S-Supp-D-ce.xpt | 361.39 MB | ||
| FDA-CBER-2021-5683-0205318 to -0208520_125742_S1_M5_c4591001-S-Supp-D-ex.xpt | 44.73 MB | ||
| FDA-CBER-2021-5683-0208521 to -0216666_125742_S1_M5_c4591001-S-Supp-D-suppvs.xpt | 39.16 MB | ||
| STN 125742-0-0 Section 2.5 Clinical Overview reissue.pdf | 4.72 MB | ||
| pd-production-070122 | |||
| 125742_S1_M5_5351_c4591001-fa-interim-narrative-sensitive.pdf | 18.85 MB | ||
| 125742_S1_M5_5351_c4591001-fa-interim-sap.pdf | 3.23 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-adverse-events.pdf | 183.44 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-compliance-sensitive.pdf | 1.2 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-discontinued-patients.pdf | 4.19 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-efficacy-response.pdf | 1.22 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-errata.pdf | 1.8 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-excluded-patients-sensitive.pdf | 2.79 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-excluded-patients.pdf | 1.29 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-interlab-standard.pdf | 10.87 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-lab-measurements-sensitive.pdf | 5.4 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-protocol-deviations.pdf | 1.63 MB | ||
| 125742_S1_M5_5351_c4591001-interim-mth6-sap.pdf | 5.4 MB | ||
| 125742_S2_M1_com195lkz-carton-kzoo.pdf | 1023.85 KB | ||
| 125742_S2_M1_com195lpus-carton-puurs.pdf | 691.06 KB | ||
| 125742_S2_M1_com25ctkz-carton-kzoo.pdf | 631.94 KB | ||
| 125742_S2_M1_com25ctpus-carton-puurs.pdf | 671.91 KB | ||
| 125742_S2_M1_comvlabkz-vial-kzoo.pdf | 863.25 KB | ||
| 125742_S2_M1_comvlabp-vial-puurs.pdf | 648.34 KB | ||
| 125742_S2_M1_fk-diluent-carton.pdf | 607.13 KB | ||
| 125742_S2_M1_fk-diluent-stamp.pdf | 598.24 KB | ||
| 125742_S2_M1_hospira-diluent-carton.pdf | 987.15 KB | ||
| 125742_S2_M1_hospira-diluent-label.pdf | 776.28 KB | ||
| 125742_S2_M1_loa-dmf-011321-vials.pdf | 1019.09 KB | ||
| 125742_S2_M1_loa-dmf-011793-vials.pdf | 701.08 KB | ||
| 125742_S2_M1_loa-dmf-011820-vials.pdf | 616.16 KB | ||
| 125742_S2_M1_loa-dmf-012683-vials.pdf | 630.9 KB | ||
| 125742_S2_M1_loa-dmf-031786-vials.pdf | 1.95 MB | ||
| 125742_S2_M1_loa-dmf-10953-stopper.pdf | 860.66 KB | ||
| 125742_S2_M1_right-of-reference.pdf | 1.73 MB | ||
| 125742_S2_M5_5354_wi235284-protocol.pdf | 15.5 MB | ||
| FDA-CBER-2021-5683-0225100 to -0225597_125742_S1_M5_c4591001-A-D-adcm.xpt | 46.4 MB | ||
| FDA-CBER-2021-5683-0225598 to -0282129_125742_S1_M5_c4591001-A-Supp-D-adfacevd.xpt | 3.95 GB | ||
| FDA-CBER-2021-5683-0282130 to -0282328_125742_S1_M5_c4591001-S-D-cm.xpt | 3.99 MB | ||
| FDA-CBER-2021-5683-0282329 to -0282365_125742_S1_M5_c4591001-S-D-ie.xpt | 479.61 KB | ||
| FDA-CBER-2021-5683-0282366 to -0285643_125742_S1_M5_c4591001-S-D-mb.xpt | 48.15 MB | ||
| FDA-CBER-2021-5683-0285644 to -0285651_125742_S1_M5_c4591001-S-D-mo.xpt | 75.78 KB | ||
| FDA-CBER-2021-5683-0285652 to -0286071_125742_S1_M5_c4591001-S-D-pe.xpt | 8.89 MB | ||
| FDA-CBER-2021-5683-0286072 to -0286266_125742_S1_M5_c4591001-S-Supp-D-relrec.xpt | 568.2 KB | ||
| FDA-CBER-2021-5683-0286267 to -0296903_125742_S1_M5_c4591001-S-Supp-D-suppce.xpt | 83.19 MB | ||
| FDA-CBER-2021-5683-0296904 to -0307543_125742_S1_M5_c4591001-S-D-suppce.xpt | 53.58 MB | ||
| pd-production-111721 | |||
| 5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdf | 8.01 MB | ||
| 5.2-tabular-listing.pdf | 1.72 MB | ||
| 5.3.6-postmarketing-experience.pdf | 983.55 KB | ||
| BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txt | 9.11 KB | ||
| BATES-93_tv.xpt | 15.55 KB | ||
| pd-production-120121 | |||
| Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdf | 12.29 MB | ||
| Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdf | 13.78 MB | ||
| pd-production-121321 | |||
| BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt | 8.5 KB | ||
| BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt | 8.52 KB | ||
| BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt | 9.11 KB | ||
| BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt | 4.53 KB | ||
| BATES-FDA-CBER-2021-5683-0002376_relrec.xpt | 566.64 KB | ||
| BATES-FDA-CBER-2021-5683-0002377_supppr.xpt | 71.8 KB | ||
| BATES-FDA-CBER-2021-5683-0002378_ta.xpt | 8.44 KB | ||
| BATES-FDA-CBER-2021-5683-0002379_te.xpt | 3.28 KB | ||
| BATES-FDA-CBER-2021-5683-0002380_ti.xpt | 36.95 KB | ||
| CRFs-for-site-1055.pdf | 6.42 MB | ||
| STN-125742_0_0-Section-2.5-Clinical-Overview.pdf | 4.2 MB | ||
| STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdf | 3.15 MB | ||
| STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdf | 6.5 MB | ||
| signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf | 206.58 KB | ||
| pd-production-122221 | |||
| Supplemental-Index-12-22-21.pdf | 1.94 MB | ||
| pd-production-123021 | |||
| CRFs-for-site-1081.pdf | 13.2 MB |
The Pfizer Documents - July 2022 Update
| torrent name | size | uploader | age | seed | leech |
|---|---|---|---|---|---|
| 528.81 MB | Anonymous | 4 years | 0 | 3 |
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