Public Health and Medical Professionals for Transparency Documents

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

File Name	Date Produced	File Size	Link
091621-Complaint.pdf	September 16, 2021	1 MB	Download
111521-Second-Joint-Status-Report.pdf	November 15, 2021	382 KB	Download
FDA Brief in Advance of Scheduling Conference.pdf	December 6, 2021	273 KB	Download
FDA Appendix in Support.pdf	December 6, 2021	9 MB	Download
Brief, Memorandum in Support filed by Public Health and Medical Professionals for Transparency re [21] Order Setting Deadline,Hearing.pdf	December 7, 2021	239 KB	Download
Appendix in Support filed by Public Health and Medical Professionals for Transparency re [26] Brief, Memorandum in Support of Motion.pdf	December 7, 2021	16 MB	Download
FDA’s Reply re Brief in Support of Motion.pdf	December 13, 2021	280 KB	Download
FDA’s Appendix in Support of Brief.pdf	December 13, 2021	1 MB	Download
REPLY filed by Public Health and Medical Professionals for Transparency re [22] Brief, Memorandum in Support of Motion.pdf	December 13, 2021	175 KB	Download
Appendix in Support filed by Public Health and Medical Professionals for Transparency re [31] Reply.pdf	December 13, 2021	24 MB	Download
ORDER_2022_01_06.pdf	January 6, 2022	169 KB	Download
037 – Brief Memorandum in Support filed by FDA re [36] MOTION To Partially Modify Scheduling Order.pdf	January 18, 2022	247 KB	Download
038 – Appendix in Support filed by FDA re [36] MOTION To Partially Modify Scheduling Order.pdf	January 18, 2022	1 MB	Download
041 – Memorandum in Support filed by Pfizer, Inc. re [40] MOTION to Intervene for a Limited Purpose.pdf	January 21, 2022	1,014 KB	Download
044 – PL PHPMT’S MOL IN OPPOSITION TO DEFENDANT’S MOTION TO MODIFY THE SCHEDULING ORDER OF THE COURT.pdf	January 24, 2022	420 KB	Download
046 – RESPONSE filed by Food and Drug Administration re [40] MOTION to Intervene for a Limited Purpose.pdf	January 25, 2022	128 KB	Download
047 – PLAINTIFF’S RESPONSE TO PFIZER INC.’S MOTION FOR LEAVE TO INTERVENE FOR A LIMITED PURPOSE.pdf	January 25, 2022	293 KB	Download
056 – ORDER GRANTING IN PART THE MOTION TO MODIFY THE PRODUCTION SCHEDULE AND ADDOPTS THE JOINT STATUS REPORT MODIFIED AGREED PRODUCTION SCHEDULE.pdf	February 2, 2022	124 KB	Download
Order February 7, 2022.pdf	February 7, 2022	151 KB	Download
034 – Transcript of Scheduling Conference (December 14, 2021).pdf	March 16, 2022	141 KB	Download

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