Remarks: PFIZER (PHMP) for Transparency Documents Files: PHMP is non-profit, made up of public health professionals, medical professionals, scientists, and journalists exists solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines. The PHMP organization takes no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses. Any data PHMP receives is made public. FULL STORY HERE: https://www.4cmitv.com/2022/05/08/pfizer-phmp-for-transparency-documents-files/
BACKGROUND HEADLINES: Public Health and Medical Professionals (PHMP) for Transparency PFIZER Documents
| File Name | Date Produced | File Size | Link |
| FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.zip (.xpt) | May 2, 2022 | 7 MB | Download |
| FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.zip (.xpt) | May 2, 2022 | 81 MB | Download |
| FDA-CBER-2021-5683-0059000 to -0065773_125742_S1_M5_c4591001-A-D-adcevd.zip (.xpt) | May 2, 2022 | 9 MB | Download |
| FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xpt | May 2, 2022 | 44 MB | Download |
| FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xsl | May 2, 2022 | 183 KB | Download |
| FDA CBER 2021 5683 0058795 to 0058828_125742_S1_M5_bnt162 01 A define 2 0 0.xsl | May 2, 2022 | 183 KB | Download |
| FDA CBER 2021 5683 0058829 to 0058954_125742_S1_M5_bnt162 01 S define.xml | May 2, 2022 | 985 KB | Download |
| FDA CBER 2021 5683 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xml | May 2, 2022 | 300 KB | Download |
| FDA CBER 2021 5683 0058653 to 0058675_125742_S1_M5_c4591001 S Supp define 2 0 0.xsl | May 2, 2022 | 183 KB | Download |
| FDA CBER 2021 5683 0058676 to 0058794_125742_S1_M5_bnt162 01 A define.xsl | May 2, 2022 | 828 KB | Download |
| FDA CBER 2021 5683 0058595 to 0058614_125742_S1_M5_c4591001 S define 2 0 0.xsl | May 2, 2022 | 183 KB | Download |
| FDA CBER 2021 5683 0058459 to 0058478_125742_S1_M5_c4591001 A Supp define 2 0 0.xsl | May 2, 2022 | 183 KB | Download |
| FDA CBER 2021 5683 0058479 to 0058594_125742_S1_M5_c4591001 S define.xml | May 2, 2022 | 904 KB | Download |
| FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xml | May 2, 2022 | 692 KB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061098.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061176.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061094.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061040.pdf | May 2, 2022 | 4 MB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061052.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1006 10061020.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051411.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051387.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051293.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051347.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051214.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051054.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051069.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031038.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_CRF_c4591001 1001 10011100.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1001 10011135.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1001 10011093.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_CRF_c4591001 1005 10051047.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031197.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031207.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031186.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031149.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031113.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031111.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001 1003 10031065.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_bnt162 01 S acrf.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_bnt162 01 A adrg.pdf | May 2, 2022 | 891 KB | Download |
| 125742_S1_M5_c4591001 S csdrg.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_c4591001 S Supp acrf.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_c4591001 S acrf.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_bnt162 01 S csdrg.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdf | May 2, 2022 | 12 MB | Download |
| 125742_S1_M5_5351_c4591001 interim mth6 sample crf.pdf | May 2, 2022 | 5 MB | Download |
| 125742_S1_M5_5351_c4591001 interim mth6 randomization sensitive.pdf | May 2, 2022 | 65 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 sample crf.pdf | May 2, 2022 | 9 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 report body.pdf | May 2, 2022 | 42 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 protocol deviations.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 protocol.pdf | May 2, 2022 | 10 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 patient batches.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 notes for reader.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 synopsis.pdf | May 2, 2022 | 4 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 sponsor signature.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 sap.pdf | May 2, 2022 | 3 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdf | May 2, 2022 | 91 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 discontinued patients.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 demographics.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 compliance.pdf | May 2, 2022 | 7 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 adverse events.pdf | May 2, 2022 | 7 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 investigators.pdf | May 2, 2022 | 6 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 invest signature.pdf | May 2, 2022 | 634 KB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 iec irb.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_bnt162 01 interim3 excluded patients.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01_10075.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01_10010.pdf | May 2, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_bnt162 01_20215.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01_20242.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_bnt162 01_20116.pdf | May 2, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdf | April 1, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdf | April 1, 2022 | 8 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdf | April 1, 2022 | 677 KB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-demographics.pdf | April 1, 2022 | 28 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdf | April 1, 2022 | 869 KB | Download |
| 125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdf | April 1, 2022 | 1 MB | Download |
| reissue_5.3.6 postmarketing experience.pdf | April 1, 2022 | 958 KB | Download |
| 125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf | April 1, 2022 | 28 MB | Download |
| 125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdf | April 1, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdf | April 1, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdf | April 1, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdf | April 1, 2022 | 5 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf | April 1, 2022 | 59 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-randomization.pdf | April 1, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-publications.pdf | April 1, 2022 | 10 MB | Download |
| 125742_S1_M1_priority-review-request.pdf | March 24, 2022 | 2 MB | Download |
| FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx | March 1, 2022 | 10 KB | Download |
| FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsx | March 1, 2022 | 9 KB | Download |
| FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx | March 1, 2022 | 23 KB | Download |
| FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx | March 1, 2022 | 35 KB | Download |
| FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsx | March 1, 2022 | 12 KB | Download |
| 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 | Download |
| 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 | Download |
| FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsx | March 1, 2022 | 29 KB | Download |
| 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 | Download |
| FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx | March 1, 2022 | 19 KB | Download |
| FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx | March 1, 2022 | 11 KB | Download |
| FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsx | March 1, 2022 | 24 KB | Download |
| FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx | March 1, 2022 | 21 KB | Download |
| FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx | March 1, 2022 | 12 KB | Download |
| FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx | March 1, 2022 | 12 KB | Download |
| FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsx | March 1, 2022 | 10 KB | Download |
| FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsx | March 1, 2022 | 9 KB | Download |
| FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsx | March 1, 2022 | 9 KB | Download |
| FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsx | March 1, 2022 | 14 KB | Download |
| FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsx | March 1, 2022 | 9 KB | Download |
| FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsx | March 1, 2022 | 10 KB | Download |
| FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx | March 1, 2022 | 12 KB | Download |
| FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsx | March 1, 2022 | 17 KB | Download |
| FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsx | March 1, 2022 | 9 KB | Download |
| FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsx | March 1, 2022 | 10 KB | Download |
| FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xsl | March 1, 2022 | 183 KB | Download |
| FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx | March 1, 2022 | 13 KB | Download |
| FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx | March 1, 2022 | 13 KB | Download |
| 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 | Download |
| FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt | March 1, 2022 | 43 KB | Download |
| FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt | March 1, 2022 | 45 KB | Download |
| 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 | Download |
| FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txt | March 1, 2022 | 197 KB | Download |
| 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 | Download |
| 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 | Download |
| FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txt | March 1, 2022 | 27 KB | Download |
| 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 | Download |
| 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 | Download |
| FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt | March 1, 2022 | 24 KB | Download |
| 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 | Download |
| 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 | Download |
| FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt | March 1, 2022 | 11 KB | Download |
| FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt | March 1, 2022 | 49 KB | Download |
| FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt | March 1, 2022 | 32 KB | Download |
| 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 | Download |
| 125742_S1_M5_CRF_c4591001-1085-10851216 | March 1, 2022 | 1 MB | Download |
| FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas | March 1, 2022 | 81 KB | Download |
| FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas | March 1, 2022 | 20 KB | Download |
| FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas | March 1, 2022 | 15 KB | Download |
| FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas | March 1, 2022 | 35 KB | Download |
| FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas | March 1, 2022 | 18 KB | Download |
| FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas | March 1, 2022 | 15 KB | Download |
| FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas | March 1, 2022 | 15 KB | Download |
| 125742_S1_M5_CRF_c4591001-1085-10851246.pdf | March 1, 2022 | 1 MB | Download |
| 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 | Download |
| 125742_S1_M5_c4591001-T-S-roadmap.pdf | March 1, 2022 | 703 KB | Download |
| 125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M5_c4591001-A-report-cci-renal.pdf | March 1, 2022 | 629 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-rheumatic.pdf | March 1, 2022 | 629 KB | Download |
| 125742_S1_M5_CRF_c4591001-1085-10851129.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001-1085-10851018.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M5_CRF_c4591001-1085-10851116.pdf | March 1, 2022 | 1 MB | Download |
| 125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdf | March 1, 2022 | 17 MB | Download |
| 125742_S1_M5_c4591001-T-S-suppl-arg.pdf | March 1, 2022 | 738 KB | Download |
| 125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdf | March 1, 2022 | 667 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-lymphoma.pdf | March 1, 2022 | 640 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdf | March 1, 2022 | 626 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-leukemia.pdf | March 1, 2022 | 631 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdf | March 1, 2022 | 632 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-pulmonary.pdf | March 1, 2022 | 630 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdf | March 1, 2022 | 625 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-mild-liver.pdf | March 1, 2022 | 628 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdf | March 1, 2022 | 626 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdf | March 1, 2022 | 636 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-mi.pdf | March 1, 2022 | 624 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdf | March 1, 2022 | 670 KB | Download |
| 125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdf | March 1, 2022 | 846 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdf | March 1, 2022 | 629 KB | Download |
| 125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdf | March 1, 2022 | 607 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdf | March 1, 2022 | 627 KB | Download |
| 125742_S1_M5_c4591001-A-comorbidity-categories.pdf | March 1, 2022 | 637 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdf | March 1, 2022 | 626 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-chf.pdf | March 1, 2022 | 628 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-dementia.pdf | March 1, 2022 | 626 KB | Download |
| 125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdf | March 1, 2022 | 632 KB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdf | March 1, 2022 | 5 MB | Download |
| 125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdf | March 1, 2022 | 620 KB | Download |
| 125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdf | March 1, 2022 | 634 KB | Download |
| 125742_S1_M5_c4591001-A-adrg.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M5_c4591001-A-bmi-12-15-scale.pdf | March 1, 2022 | 627 KB | Download |
| 125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf | March 1, 2022 | 37 MB | Download |
| 125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdf | March 1, 2022 | 602 KB | Download |
| 125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdf | March 1, 2022 | 13 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf | March 1, 2022 | 31 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-errata.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdf | March 1, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdf | March 1, 2022 | 889 KB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-compliance.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M4_4223_R-20-0072.pdf | March 1, 2022 | 5 MB | Download |
| 125742_S1_M4_4223_185350.pdf | March 1, 2022 | 1 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdf | March 1, 2022 | 12 MB | Download |
| 125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf | March 1, 2022 | 16 MB | Download |
| 125742_S1_M2_26_pharmkin-written-summary.pdf | March 1, 2022 | 1 MB | Download |
| 125742_S1_M2_24_nonclinical-overview.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M2_26_pharmkin-tabulated-summary.pdf | March 1, 2022 | 1 MB | Download |
| 125742_S1_M2_22_introduction.pdf | March 1, 2022 | 670 KB | Download |
| 125742_S1_M1_waiver-req-designated-suffix.pdf | March 1, 2022 | 3 MB | Download |
| 125742_S1_M1_us-agent-authorization.pdf | March 1, 2022 | 1 MB | Download |
| 125742_S1_M1_userfee.pdf | March 1, 2022 | 628 KB | Download |
| 125742_S1_M2_27_synopses-indiv-studies.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M1_trans-of-oblig.pdf | March 1, 2022 | 717 KB | Download |
| 125742_S1_M2_27_literature-references.pdf | March 1, 2022 | 2 MB | Download |
| 125742_S1_M1_ipsp-agreed-letter.pdf | March 1, 2022 | 658 KB | Download |
| 125742_S1_M1_financial-cert-3454.pdf | March 1, 2022 | 3 MB | Download |
| 125742_S1_M1_financial-cert-bias.pdf | March 1, 2022 | 696 KB | Download |
| 125742_S1_M1_fast-track-designation.pdf | March 1, 2022 | 649 KB | Download |
| 125742_S1_M1_exclusivity-claim.pdf | March 1, 2022 | 616 KB | Download |
| 125742_S1_M1_cover.pdf | March 1, 2022 | 1 MB | Download |
| 125742_S1_M1_debarment.pdf | March 1, 2022 | 656 KB | Download |
| 125742_S1_M1_3674.pdf | March 1, 2022 | 5 MB | Download |
| 125742_S1_M1_356h.pdf | March 1, 2022 | 714 KB | Download |
| 125742_S1_M1_priority-review-request.pdf | March 1, 2022 | 2 MB | Download |
| CRFs for site 1128.pdf | January 31, 2022 | 14 MB | Download |
| CRFs for site 1096.pdf | January 18, 2022 | 11 MB | Download |
| CRFs for site 1081.pdf | December 30, 2021 | 13 MB | Download |
| Supplemental Index 12-22-21.pdf | December 22, 2021 | 2 MB | Download |
| STN 125742_0_0 Section 2.7.4 summary-clin-safety.pdf | December 13, 2021 | 6 MB | Download |
| STN 125742_0_0 Section 2.7.3 Summary of Clinical Efficacy.pdf | December 13, 2021 | 3 MB | Download |
| STN 125742_0_0 Section 2.5 Clinical Overview.pdf | December 13, 2021 | 4 MB | Download |
| CRFs for site 1055.pdf | December 13, 2021 | 6 MB | Download |
| BATES-FDA-CBER-2021-5683-0002376_relrec.xpt | December 13, 2021 | 567 KB | Download |
| BATES-FDA-CBER-2021-5683-0002380_ti.xpt | December 13, 2021 | 37 KB | Download |
| BATES-FDA-CBER-2021-5683-0002379_te.xpt | December 13, 2021 | 3 KB | Download |
| BATES-FDA-CBER-2021-5683-0002378_ta.xpt | December 13, 2021 | 8 KB | Download |
| signed F21-5683 CBER Dec 13 2021 Response Letter.pdf | December 13, 2021 | 207 KB | Download |
| BATES-FDA-CBER-2021-5683-0002377_supppr.xpt | December 13, 2021 | 72 KB | Download |
| BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt | December 13, 2021 | 5 KB | Download |
| BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt | December 13, 2021 | 9 KB | Download |
| BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt | December 13, 2021 | 9 KB | Download |
| BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt | December 13, 2021 | 9 KB | Download |
| Pages 42-289-Section 5.2 – listing-clinical-sites-cvs_Part B.pdf | December 1, 2021 | 14 MB | Download |
| Pages 42-289-Section 5.2 – listing-clinical-sites-cvs_Part A.pdf | December 1, 2021 | 12 MB | Download |
| 5.2 listing of clinical sites and cvs pages 1-41.pdf | November 17, 2021 | 8 MB | Download |
| 5.2 tabular listing.pdf | November 17, 2021 | 2 MB | Download |
| 5.3.6 postmarketing experience.pdf | November 17, 2021 | 984 KB | Download |
| BATES-93_tv.xpt | November 17, 2021 | 16 KB | Download |
| BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txt | November 17, 2021 | 9 KB | Download |
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