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BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt8.50KB2022-04-05 12:10:50BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt8.52KB2022-04-05 12:10:58BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt9.11KB2022-04-05 12:11:01BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt4.53KB2022-04-05 12:11:09BATES-FDA-CBER-2021-5683-0002376_relrec.xpt566.64KB2022-04-05 12:12:56BATES-FDA-CBER-2021-5683-0002377_supppr.xpt71.80KB2022-04-05 12:11:16BATES-FDA-CBER-2021-5683-0002378_ta.xpt8.44KB2022-04-05 12:12:35BATES-FDA-CBER-2021-5683-0002379_te.xpt3.28KB2022-04-05 12:12:41BATES-FDA-CBER-2021-5683-0002380_ti.xpt36.95KB2022-04-05 12:12:46CRFs-for-site-1055.pdf6.42MB2022-04-05 12:13:17CRFs-for-site-1081.pdf13.20MB2022-04-05 12:26:05Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdf12.29MB2022-04-05 12:09:38Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdf13.78MB2022-04-05 12:10:33STN-125742_0_0-Section-2.5-Clinical-Overview.pdf4.20MB2022-04-05 12:13:43STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdf3.15MB2022-04-05 12:14:08STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdf6.50MB2022-04-05 12:24:33Supplemental-Index-12-22-21.pdf1.94MB2022-04-05 12:25:00signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf206.58KB2022-04-05 12:11:42