Court Filing — TXND Case 353278, Doc. 23
- Date
- 2021-12-06
Full text
Exhibit A
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Exhibit B
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Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 21 of 110 PageID 260
~12 pages
~289 page
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5.3.5
Expanded sections for the Phase 1 / 2/ 3 study are below
~31 pages
~48 pages
~2033 pages
~1 page
~3611 pages
~1584 pages
~ 2 pages
~ 3697 pages
~ 14 pages
Index not being provided for
section 5.3.1 (would need
disclosure review first)
~240 pages (~20
journal articles)
~38 pages
Details of 5.3.5
are provided
below
There are 2
studies, shown
here. The record
descriptions for
each follow
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That is the end of the first study
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See below for the Phase I/II study
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Exhibit C
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From:
Aaron Siri
To:
Enlow, Courtney D. (CIV)
Cc:
Elizabeth Brehm; Gabrielle Palmer
Subject:
[EXTERNAL] RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D. Tex.
2021)
Date:
Thursday, November 04, 2021 4:06:13 PM
Attachments:
image001.png
image002.png
image003.png
image004.png
Also, CFRs for site 1085 which is on page 33 of the PDF.
From: Aaron Siri
Sent: Thursday, November 4, 2021 12:58 PM
To: Enlow, Courtney D. (CIV) <Courtney.D.Enlow@usdoj.gov>
Cc: Elizabeth Brehm <ebrehm@sirillp.com>; Gabrielle Palmer <gpalmer@sirillp.com>
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D.
Tex. 2021)
Hi Courtney,
Nice meeting yesterday. Based on our follow-up preliminary discussion with our client earlier today,
they would like to know if the FDA will produce the following items by November 17:
1. Pdf page 27: CRFs for site 1055
2. Pdf page 31: CRFs for site 1081
3. Pdf page 38: CRFs for site 1096
4. Pdf page 46: CRFs for site 1128
5. Pdf page 10: Program Files/SAS files. They want 3 to 4 SAS files as a sample, in the first instance,
so that they client can assess whether it would like to prioritize the complete universe of SAS
files.
6. Pdf page 1: 5.2 - Tabular Listing of all Clinical Studies
7. Pdf page 1: 4 – Nonclinical Study Reports
8. Pdf page 2: 5.3.6 - Reports of Postmarketing Experience
9. Pdf page 3: 16.1.1 - Protocol and/or Amendment, and specifically, Final Analysis Interim
Independent Oversight Committees
10. Pdf page 6: Under the Analysis Datasets (ADaM), the Analysis Data Reviewers Guide, Analysis
Dataset Definition, and Analysis Dataset Definition Stylesheet
11. Pdf page 11: Tabulation Datasets
If we can get agreement on producing these limited items as noted, we can advise as much in our
joint letter and that we are continuing to discuss a production schedule for the remaining data and
information.
Please let us know if the FDA will agree to their proposal.
Thanks,
Aaron
From: Enlow, Courtney D. (CIV) <Courtney.D.Enlow@usdoj.gov>
Sent: Thursday, November 4, 2021 11:07 AM
To: Gabrielle Palmer <gpalmer@sirillp.com>
Cc: Aaron Siri <aaron@sirillp.com>; Elizabeth Brehm <ebrehm@sirillp.com>
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D.
Tex. 2021)
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