Index of /ipfs/QmbrnETT1FkV9eCSoNof7uyoAgD27XbtYvJECjDhwe2C3v
QmbrnETT1FkV9eCSoNof7uyoAgD27XbtYvJECjDhwe2C3v
 223 MB
 
125742_S1_M1_356h.pdf
QmcT…F3v8
732 kB
 
125742_S1_M1_3674.pdf
QmQU…TzrH
5.4 MB
 
125742_S1_M1_cover.pdf
QmUE…uUwy
1.4 MB
 
125742_S1_M1_debarment.pdf
QmWA…xQ1N
672 kB
 
125742_S1_M1_exclusivity-claim.pdf
QmUB…mPhZ
631 kB
 
125742_S1_M1_fast-track-designation.pdf
QmVD…czJG
665 kB
 
125742_S1_M1_financial-cert-3454.pdf
QmdN…EeBY
3.6 MB
 
125742_S1_M1_financial-cert-bias.pdf
Qmec…h3H6
713 kB
 
125742_S1_M1_ipsp-agreed-letter.pdf
QmXM…YiV9
674 kB
 
125742_S1_M1_priority-review-request.pdf
QmQW…cDmo
1.7 MB
 
125742_S1_M1_trans-of-oblig.pdf
QmZc…58GN
734 kB
 
125742_S1_M1_us-agent-authorization.pdf
QmeZ…pd6Y
1.1 MB
 
125742_S1_M1_userfee.pdf
QmcY…1Vhf
643 kB
 
125742_S1_M1_waiver-req-designated-suffix.pdf
Qmc9…G77H
2.9 MB
 
125742_S1_M2_22_introduction.pdf
QmRC…Pmcx
686 kB
 
125742_S1_M2_24_nonclinical-overview.pdf
QmPj…3YEX
1.7 MB
 
125742_S1_M2_26_pharmkin-tabulated-summary.pdf
Qmew…SuST
1.4 MB
 
125742_S1_M2_26_pharmkin-written-summary.pdf
QmdG…SYx5
1.5 MB
 
125742_S1_M2_27_literature-references.pdf
QmeZ…Nvbp
1.8 MB
 
125742_S1_M2_27_synopses-indiv-studies.pdf
QmYs…mznH
1.8 MB
 
125742_S1_M4_4223_185350.pdf
QmUf…G6a7
1.5 MB
 
125742_S1_M4_4223_R-20-0072.pdf
QmZy…UjrR
5.5 MB
 
125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdf
QmQu…AvEP
911 kB
 
125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdf
QmdQ…uonD
1.3 MB
 
125742_S1_M5_5351_c4591001-fa-interim-compliance.pdf
QmaB…a9Zt
2.1 MB
 
125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdf
QmaF…PLBr
2.5 MB
 
125742_S1_M5_5351_c4591001-fa-interim-errata.pdf
QmUr…DU6h
2.4 MB
 
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf
QmTU…7Rkw
16 MB
 
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdf
QmUd…to9P
1.9 MB
 
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdf
QmYN…9VjV
5.0 MB
 
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdf
QmS9…NELf
13 MB
 
125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdf
QmTx…JnyP
2.4 MB
 
125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf
QmZ3…2skw
33 MB
 
125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdf
QmWp…68Te
14 MB
 
125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf
Qmby…9EMH
39 MB
 
125742_S1_M5_CRF_c4591001-1085-10851018.pdf
QmSo…XKj4
2.4 MB
 
125742_S1_M5_CRF_c4591001-1085-10851116.pdf
QmdF…EJyH
1.3 MB
 
125742_S1_M5_CRF_c4591001-1085-10851129.pdf
QmPY…BF2i
2.0 MB
 
125742_S1_M5_CRF_c4591001-1085-10851216.pdf
Qmc8…tXhV
1.3 MB
 
125742_S1_M5_CRF_c4591001-1085-10851246.pdf
QmSR…9Jsm
1.2 MB
 
125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdf
QmXn…UAsQ
617 kB
 
125742_S1_M5_c4591001-A-adrg.pdf
QmQS…t2dk
1.6 MB
 
125742_S1_M5_c4591001-A-bmi-12-15-scale.pdf
QmVz…L6H6
642 kB
 
125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdf
QmW7…bbuJ
650 kB
 
125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdf
QmPN…rFwF
635 kB
 
125742_S1_M5_c4591001-A-comorbidity-categories.pdf
QmZs…9wFi
652 kB
 
125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdf
QmNn…BXxr
622 kB
 
125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdf
QmVR…YWko
867 kB
 
125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdf
QmPd…2uRk
644 kB
 
125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdf
QmPG…syxh
686 kB
 
125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdf
QmVJ…C4JS
647 kB
 
125742_S1_M5_c4591001-A-report-cci-chf.pdf
QmSL…Vh8v
643 kB
 
125742_S1_M5_c4591001-A-report-cci-dementia.pdf
Qmar…t1CB
641 kB
 
125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdf
QmNz…XVCG
641 kB
 
125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdf
QmQG…UYyk
642 kB
 
125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdf
QmSP…qFfu
641 kB
 
125742_S1_M5_c4591001-A-report-cci-leukemia.pdf
QmfA…doe7
647 kB
 
125742_S1_M5_c4591001-A-report-cci-lymphoma.pdf
Qmax…VC5N
656 kB
 
125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdf
QmQs…VuiS
651 kB
 
125742_S1_M5_c4591001-A-report-cci-mi.pdf
QmfS…ZM1H
639 kB
 
125742_S1_M5_c4591001-A-report-cci-mild-liver.pdf
QmRR…h6FZ
644 kB
 
125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdf
QmYw…Tdmk
641 kB
 
125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdf
QmVX…KQ17
640 kB
 
125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdf
QmTW…pPx6
647 kB
 
125742_S1_M5_c4591001-A-report-cci-pulmonary.pdf
Qmcd…4Xy6
645 kB
 
125742_S1_M5_c4591001-A-report-cci-renal.pdf
QmYD…461X
644 kB
 
125742_S1_M5_c4591001-A-report-cci-rheumatic.pdf
QmcD…5W6C
645 kB
 
125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdf
Qmcd…18cq
2.3 MB
 
125742_S1_M5_c4591001-T-S-roadmap.pdf
QmRJ…3pqX
720 kB
 
125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdf
QmaR…q6DT
683 kB
 
125742_S1_M5_c4591001-T-S-suppl-arg.pdf
QmVw…qUQr
756 kB
 
125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdf
QmWR…FXfY
18 MB
 
FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txt
Qme2…cTG1
14 kB
 
FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txt
QmTz…37S7
15 kB
 
FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txt
QmRu…CRjp
15 kB
 
FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txt
QmTx…yzeG
16 kB
 
FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txt
QmRS…JRX4
36 kB
 
FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txt
Qmcf…rHd9
18 kB
 
FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txt
QmTZ…GYLD
83 kB
 
FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txt
QmTS…dahs
20 kB
 
FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txt
QmRw…AzEL
20 kB
 
FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txt
QmV5…XNgR
13 kB
 
FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txt
QmYe…dCsB
73 kB
 
FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txt
QmUy…3KHY
198 kB
 
FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txt
QmYb…JqLr
28 kB
 
FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt
Qmba…q5yS
33 kB
 
FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txt
QmVm…FQfp
160 kB
 
FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt
Qmek…xzQk
11 kB
 
FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt
QmVr…GRg5
50 kB
 
FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt
Qmbv…SWRf
25 kB
 
FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txt
QmZX…fq53
76 kB
 
FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txt
QmZb…VrgR
76 kB
 
FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txt
QmYu…ofYe
30 kB
 
FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txt
Qmaj…uXhz
77 kB
 
FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txt
QmUv…pPSj
202 kB
 
FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt
QmWf…NXkL
44 kB
 
FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt
QmW6…PFk6
46 kB
 
FDA-CBER-2021-5683-0023150 to -0023454_125742_S1_M5_c4591001-A-define.xml
QmTX…xNoY
1.4 MB
 
FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xsl
QmbV…HHQi
188 kB
 
FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx
QmRR…tD4q
13 kB
 
FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsx
QmSs…r96q
29 kB
 
FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx
QmSu…jDzo
19 kB
 
FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx
QmUb…7gjB
19 kB
 
FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx
QmTE…YhYG
23 kB
 
FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx
Qmer…Mwtd
86 kB
 
FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx
QmSP…W8xV
23 kB
 
FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx
QmRt…TYsG
36 kB
 
FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsx
QmT3…LfKF
13 kB
 
FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx
QmRJ…HW2s
10 kB
 
FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsx
Qmbq…eJD5
9.7 kB
 
FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsx
QmQK…FqDC
9.4 kB
 
FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsx
QmUM…ivzK
10 kB
 
FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsx
QmWM…et6v
9.8 kB
 
FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx
QmR8…PmhU
12 kB
 
FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsx
Qmab…UHhc
17 kB
 
FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsx
QmNh…RgcD
15 kB
 
FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsx
QmV1…vb3A
9.1 kB
 
FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsx
QmfY…PhSr
11 kB
 
FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsx
Qmdm…BoNQ
9.4 kB
 
FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsx
QmSA…Rdu3
9.4 kB
 
FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx
QmPa…M8gu
12 kB
 
FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx
QmQ2…YrPG
12 kB
 
FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx
QmR7…iuoi
11 kB
 
FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsx
QmR7…adE3
24 kB
 
FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx
QmWX…DHRj
22 kB