File Name Date Produced File Size Link BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txt November 17, 2021 9 KB BATES-93_tv.xpt November 17, 2021 16 KB 5.3.6 postmarketing experience.pdf November 17, 2021 984 KB 5.2 tabular listing.pdf November 17, 2021 2 MB 5.2 listing of clinical sites and cvs pages 1-41.pdf November 17, 2021 8 MB Pages 42-289-Section 5.2 – listing-clinical-sites-cvs_Part A.pdf December 1, 2021 12 MB Pages 42-289-Section 5.2 – listing-clinical-sites-cvs_Part B.pdf December 1, 2021 14 MB BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt December 13, 2021 9 KB BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt December 13, 2021 9 KB BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt December 13, 2021 9 KB BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt December 13, 2021 5 KB BATES-FDA-CBER-2021-5683-0002377_supppr.xpt December 13, 2021 72 KB signed F21-5683 CBER Dec 13 2021 Response Letter.pdf December 13, 2021 207 KB BATES-FDA-CBER-2021-5683-0002378_ta.xpt December 13, 2021 8 KB BATES-FDA-CBER-2021-5683-0002379_te.xpt December 13, 2021 3 KB BATES-FDA-CBER-2021-5683-0002380_ti.xpt December 13, 2021 37 KB BATES-FDA-CBER-2021-5683-0002376_relrec.xpt December 13, 2021 567 KB CRFs for site 1055.pdf December 13, 2021 6 MB STN 125742_0_0 Section 2.5 Clinical Overview.pdf December 13, 2021 4 MB STN 125742_0_0 Section 2.7.3 Summary of Clinical Efficacy.pdf December 13, 2021 3 MB STN 125742_0_0 Section 2.7.4 summary-clin-safety.pdf December 13, 2021 6 MB Supplemental Index 12-22-21.pdf December 22, 2021 2 MB CRFs for site 1081.pdf December 30, 2021 13 MB CRFs for site 1096.pdf January 18, 2022 11 MB CRFs for site 1128.pdf January 31, 2022 14 MB 125742_S1_M1_priority-review-request.pdf March 1, 2022 2 MB 125742_S1_M1_356h.pdf March 1, 2022 714 KB 125742_S1_M1_3674.pdf March 1, 2022 5 MB 125742_S1_M1_cover.pdf March 1, 2022 1 MB 125742_S1_M1_debarment.pdf March 1, 2022 656 KB 125742_S1_M1_exclusivity-claim.pdf 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