Exhibit A — Case 4:21-cv-01058-P, Document 23, Filed 12/06/21 (App001)
Summary
These pages, filed as Document 23 on 12/06/21, contain Exhibit A and Exhibit B and an email chain captioned Public Health and Medical Professionals for Transparency v. FDA. A list of document sections with approximate page counts includes expanded sections for 5.3.5, and a note says an index is not being provided for section 5.3.1 because it would need disclosure review first. An email addressed to Courtney and signed Aaron asks whether the FDA will produce listed items by November 17, including CRFs for several sites, a sample of SAS files, and the tabular listing of all clinical studies. It adds that a joint letter could say discussion of a production schedule for the remaining data continues.
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- Date
- 2021-12-06
Cite this document
“Exhibit A — Case 4:21-cv-01058-P, Document 23, Filed 12/06/21 (App001).”
Original at archive.org, dated 2021-12-06. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/2021-12-06-covid-era-misc/
, SHA-256 70e4ff546a2ce63e5ac568e219ed3b1efba7c56162e97847a23583ee6f7d1ac5.Full text
Exhibit A App001 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 1 of 110 PageID 240 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 1 of 110 PageID 240 App002 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 2 of 110 PageID 241 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 2 of 110 PageID 241 App003 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 3 of 110 PageID 242 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 3 of 110 PageID 242 App004 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 4 of 110 PageID 243 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 4 of 110 PageID 243 App005 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 5 of 110 PageID 244 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 5 of 110 PageID 244 App006 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 6 of 110 PageID 245 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 6 of 110 PageID 245 App007 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 7 of 110 PageID 246 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 7 of 110 PageID 246 App008 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 8 of 110 PageID 247 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 8 of 110 PageID 247 App009 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 9 of 110 PageID 248 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 9 of 110 PageID 248 App010 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 10 of 110 PageID 249 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 10 of 110 PageID 249 App011 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 11 of 110 PageID 250 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 11 of 110 PageID 250 App012 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 12 of 110 PageID 251 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 12 of 110 PageID 251 App013 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 13 of 110 PageID 252 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 13 of 110 PageID 252 App014 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 14 of 110 PageID 253 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 14 of 110 PageID 253 App015 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 15 of 110 PageID 254 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 15 of 110 PageID 254 App016 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 16 of 110 PageID 255 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 16 of 110 PageID 255 App017 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 17 of 110 PageID 256 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 17 of 110 PageID 256 App018 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 18 of 110 PageID 257 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 18 of 110 PageID 257 App019 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 19 of 110 PageID 258 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 19 of 110 PageID 258 App020 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 20 of 110 PageID 259 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 20 of 110 PageID 259 Exhibit B App021 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 21 of 110 PageID 260 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 21 of 110 PageID 260 ~12 pages ~289 page App022 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 22 of 110 PageID 261 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 22 of 110 PageID 261 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 App023 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 23 of 110 PageID 262 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 23 of 110 PageID 262 App024 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 24 of 110 PageID 263 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 24 of 110 PageID 263 App025 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 25 of 110 PageID 264 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 25 of 110 PageID 264 App026 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 26 of 110 PageID 265 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 26 of 110 PageID 265 App027 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 27 of 110 PageID 266 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 27 of 110 PageID 266 App028 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 28 of 110 PageID 267 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 28 of 110 PageID 267 App029 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 29 of 110 PageID 268 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 29 of 110 PageID 268 App030 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 30 of 110 PageID 269 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 30 of 110 PageID 269 App031 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 31 of 110 PageID 270 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 31 of 110 PageID 270 App032 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 32 of 110 PageID 271 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 32 of 110 PageID 271 App033 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 33 of 110 PageID 272 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 33 of 110 PageID 272 App034 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 34 of 110 PageID 273 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 34 of 110 PageID 273 App035 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 35 of 110 PageID 274 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 35 of 110 PageID 274 App036 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 36 of 110 PageID 275 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 36 of 110 PageID 275 App037 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 37 of 110 PageID 276 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 37 of 110 PageID 276 App038 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 38 of 110 PageID 277 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 38 of 110 PageID 277 App039 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 39 of 110 PageID 278 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 39 of 110 PageID 278 App040 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 40 of 110 PageID 279 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 40 of 110 PageID 279 App041 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 41 of 110 PageID 280 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 41 of 110 PageID 280 App042 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 42 of 110 PageID 281 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 42 of 110 PageID 281 App043 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 43 of 110 PageID 282 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 43 of 110 PageID 282 App044 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 44 of 110 PageID 283 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 44 of 110 PageID 283 App045 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 45 of 110 PageID 284 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 45 of 110 PageID 284 App046 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 46 of 110 PageID 285 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 46 of 110 PageID 285 App047 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 47 of 110 PageID 286 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 47 of 110 PageID 286 App048 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 48 of 110 PageID 287 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 48 of 110 PageID 287 App049 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 49 of 110 PageID 288 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 49 of 110 PageID 288 App050 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 50 of 110 PageID 289 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 50 of 110 PageID 289 App051 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 51 of 110 PageID 290 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 51 of 110 PageID 290 App052 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 52 of 110 PageID 291 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 52 of 110 PageID 291 App053 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 53 of 110 PageID 292 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 53 of 110 PageID 292 App054 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 54 of 110 PageID 293 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 54 of 110 PageID 293 App055 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 55 of 110 PageID 294 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 55 of 110 PageID 294 App056 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 56 of 110 PageID 295 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 56 of 110 PageID 295 App057 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 57 of 110 PageID 296 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 57 of 110 PageID 296 App058 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 58 of 110 PageID 297 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 58 of 110 PageID 297 App059 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 59 of 110 PageID 298 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 59 of 110 PageID 298 App060 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 60 of 110 PageID 299 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 60 of 110 PageID 299 App061 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 61 of 110 PageID 300 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 61 of 110 PageID 300 App062 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 62 of 110 PageID 301 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 62 of 110 PageID 301 App063 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 63 of 110 PageID 302 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 63 of 110 PageID 302 App064 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 64 of 110 PageID 303 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 64 of 110 PageID 303 App065 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 65 of 110 PageID 304 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 65 of 110 PageID 304 App066 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 66 of 110 PageID 305 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 66 of 110 PageID 305 App067 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 67 of 110 PageID 306 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 67 of 110 PageID 306 App068 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 68 of 110 PageID 307 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 68 of 110 PageID 307 App069 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 69 of 110 PageID 308 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 69 of 110 PageID 308 App070 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 70 of 110 PageID 309 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 70 of 110 PageID 309 App071 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 71 of 110 PageID 310 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 71 of 110 PageID 310 App072 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 72 of 110 PageID 311 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 72 of 110 PageID 311 App073 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 73 of 110 PageID 312 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 73 of 110 PageID 312 App074 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 74 of 110 PageID 313 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 74 of 110 PageID 313 App075 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 75 of 110 PageID 314 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 75 of 110 PageID 314 App076 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 76 of 110 PageID 315 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 76 of 110 PageID 315 App077 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 77 of 110 PageID 316 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 77 of 110 PageID 316 App078 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 78 of 110 PageID 317 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 78 of 110 PageID 317 App079 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 79 of 110 PageID 318 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 79 of 110 PageID 318 App080 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 80 of 110 PageID 319 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 80 of 110 PageID 319 App081 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 81 of 110 PageID 320 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 81 of 110 PageID 320 App082 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 82 of 110 PageID 321 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 82 of 110 PageID 321 App083 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 83 of 110 PageID 322 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 83 of 110 PageID 322 App084 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 84 of 110 PageID 323 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 84 of 110 PageID 323 App085 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 85 of 110 PageID 324 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 85 of 110 PageID 324 App086 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 86 of 110 PageID 325 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 86 of 110 PageID 325 App087 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 87 of 110 PageID 326 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 87 of 110 PageID 326 App088 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 88 of 110 PageID 327 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 88 of 110 PageID 327 App089 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 89 of 110 PageID 328 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 89 of 110 PageID 328 App090 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 90 of 110 PageID 329 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 90 of 110 PageID 329 App091 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 91 of 110 PageID 330 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 91 of 110 PageID 330 App092 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 92 of 110 PageID 331 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 92 of 110 PageID 331 App093 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 93 of 110 PageID 332 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 93 of 110 PageID 332 App094 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 94 of 110 PageID 333 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 94 of 110 PageID 333 App095 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 95 of 110 PageID 334 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 95 of 110 PageID 334 App096 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 96 of 110 PageID 335 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 96 of 110 PageID 335 App097 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 97 of 110 PageID 336 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 97 of 110 PageID 336 App098 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 98 of 110 PageID 337 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 98 of 110 PageID 337 App099 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 99 of 110 PageID 338 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 99 of 110 PageID 338 App100 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 100 of 110 PageID 339 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 100 of 110 PageID 339 App101 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 101 of 110 PageID 340 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 101 of 110 PageID 340 App102 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 102 of 110 PageID 341 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 102 of 110 PageID 341 That is the end of the first study App103 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 103 of 110 PageID 342 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 103 of 110 PageID 342 See below for the Phase I/II study App104 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 104 of 110 PageID 343 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 104 of 110 PageID 343 App105 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 105 of 110 PageID 344 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 105 of 110 PageID 344 App106 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 106 of 110 PageID 345 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 106 of 110 PageID 345 App107 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 107 of 110 PageID 346 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 107 of 110 PageID 346 App108 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 108 of 110 PageID 347 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 108 of 110 PageID 347 Exhibit C App109 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 109 of 110 PageID 348 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 109 of 110 PageID 348 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) App110 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 110 of 110 PageID 349 Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 110 of 110 PageID 349
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