Document text
Exhibit A
App001Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 1 of 110 PageID 240Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 1 of 110 PageID 240
App002Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 2 of 110 PageID 241Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 2 of 110 PageID 241
App003Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 3 of 110 PageID 242Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 3 of 110 PageID 242
App004Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 4 of 110 PageID 243Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 4 of 110 PageID 243
App005Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 5 of 110 PageID 244Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 5 of 110 PageID 244
App006Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 6 of 110 PageID 245Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 6 of 110 PageID 245
App007Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 7 of 110 PageID 246Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 7 of 110 PageID 246
App008Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 8 of 110 PageID 247Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 8 of 110 PageID 247
App009Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 9 of 110 PageID 248Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 9 of 110 PageID 248
App010Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 10 of 110 PageID 249Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 10 of 110 PageID 249
App011Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 11 of 110 PageID 250Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 11 of 110 PageID 250
App012Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 12 of 110 PageID 251Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 12 of 110 PageID 251
App013Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 13 of 110 PageID 252Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 13 of 110 PageID 252
App014Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 14 of 110 PageID 253Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 14 of 110 PageID 253
App015Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 15 of 110 PageID 254Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 15 of 110 PageID 254
App016Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 16 of 110 PageID 255Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 16 of 110 PageID 255
App017Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 17 of 110 PageID 256Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 17 of 110 PageID 256
App018Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 18 of 110 PageID 257Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 18 of 110 PageID 257
App019Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 19 of 110 PageID 258Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 19 of 110 PageID 258
App020Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 20 of 110 PageID 259Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 20 of 110 PageID 259
Exhibit B
App021Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 21 of 110 PageID 260Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 21 of 110 PageID 260
~12pages
~289page
App022Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 22 of 110 PageID 261Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 22 of 110 PageID 261
5.3.5
Expanded sections for the Phase1 / 2/ 3 study are below
~31pages
~48pages
~2033pages
~1 page
~3611pages
~1584pages
~ 2pages
~ 3697pages
~ 14pagesIndex not being provided for
section5.3.1 (wouldneed
disclosure review first)
~240 pages(~20
journal articles)~38 pagesDetails of 5.3.5
are provided
below
There are 2
studies, shown
here. The record
descriptions for
each follow
App023Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 23 of 110 PageID 262Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 23 of 110 PageID 262
App024Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 24 of 110 PageID 263Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 24 of 110 PageID 263
App025Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 25 of 110 PageID 264Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 25 of 110 PageID 264
App026Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 26 of 110 PageID 265Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 26 of 110 PageID 265
App027Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 27 of 110 PageID 266Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 27 of 110 PageID 266
App028Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 28 of 110 PageID 267Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 28 of 110 PageID 267
App029Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 29 of 110 PageID 268Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 29 of 110 PageID 268
App030Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 30 of 110 PageID 269Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 30 of 110 PageID 269
App031Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 31 of 110 PageID 270Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 31 of 110 PageID 270
App032Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 32 of 110 PageID 271Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 32 of 110 PageID 271
App033Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 33 of 110 PageID 272Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 33 of 110 PageID 272
App034Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 34 of 110 PageID 273Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 34 of 110 PageID 273
App035Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 35 of 110 PageID 274Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 35 of 110 PageID 274
App036Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 36 of 110 PageID 275Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 36 of 110 PageID 275
App037Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 37 of 110 PageID 276Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 37 of 110 PageID 276
App038Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 38 of 110 PageID 277Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 38 of 110 PageID 277
App039Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 39 of 110 PageID 278Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 39 of 110 PageID 278
App040Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 40 of 110 PageID 279Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 40 of 110 PageID 279
App041Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 41 of 110 PageID 280Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 41 of 110 PageID 280
App042Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 42 of 110 PageID 281Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 42 of 110 PageID 281
App043Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 43 of 110 PageID 282Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 43 of 110 PageID 282
App044Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 44 of 110 PageID 283Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 44 of 110 PageID 283
App045Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 45 of 110 PageID 284Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 45 of 110 PageID 284
App046Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 46 of 110 PageID 285Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 46 of 110 PageID 285
App047Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 47 of 110 PageID 286Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 47 of 110 PageID 286
App048Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 48 of 110 PageID 287Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 48 of 110 PageID 287
App049Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 49 of 110 PageID 288Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 49 of 110 PageID 288
App050Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 50 of 110 PageID 289Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 50 of 110 PageID 289
App051Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 51 of 110 PageID 290Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 51 of 110 PageID 290
App052Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 52 of 110 PageID 291Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 52 of 110 PageID 291
App053Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 53 of 110 PageID 292Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 53 of 110 PageID 292
App054Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 54 of 110 PageID 293Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 54 of 110 PageID 293
App055Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 55 of 110 PageID 294Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 55 of 110 PageID 294
App056Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 56 of 110 PageID 295Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 56 of 110 PageID 295
App057Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 57 of 110 PageID 296Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 57 of 110 PageID 296
App058Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 58 of 110 PageID 297Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 58 of 110 PageID 297
App059Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 59 of 110 PageID 298Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 59 of 110 PageID 298
App060Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 60 of 110 PageID 299Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 60 of 110 PageID 299
App061Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 61 of 110 PageID 300Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 61 of 110 PageID 300
App062Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 62 of 110 PageID 301Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 62 of 110 PageID 301
App063Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 63 of 110 PageID 302Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 63 of 110 PageID 302
App064Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 64 of 110 PageID 303Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 64 of 110 PageID 303
App065Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 65 of 110 PageID 304Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 65 of 110 PageID 304
App066Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 66 of 110 PageID 305Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 66 of 110 PageID 305
App067Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 67 of 110 PageID 306Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 67 of 110 PageID 306
App068Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 68 of 110 PageID 307Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 68 of 110 PageID 307
App069Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 69 of 110 PageID 308Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 69 of 110 PageID 308
App070Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 70 of 110 PageID 309Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 70 of 110 PageID 309
App071Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 71 of 110 PageID 310Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 71 of 110 PageID 310
App072Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 72 of 110 PageID 311Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 72 of 110 PageID 311
App073Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 73 of 110 PageID 312Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 73 of 110 PageID 312
App074Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 74 of 110 PageID 313Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 74 of 110 PageID 313
App075Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 75 of 110 PageID 314Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 75 of 110 PageID 314
App076Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 76 of 110 PageID 315Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 76 of 110 PageID 315
App077Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 77 of 110 PageID 316Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 77 of 110 PageID 316
App078Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 78 of 110 PageID 317Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 78 of 110 PageID 317
App079Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 79 of 110 PageID 318Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 79 of 110 PageID 318
App080Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 80 of 110 PageID 319Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 80 of 110 PageID 319
App081Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 81 of 110 PageID 320Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 81 of 110 PageID 320
App082Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 82 of 110 PageID 321Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 82 of 110 PageID 321
App083Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 83 of 110 PageID 322Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 83 of 110 PageID 322
App084Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 84 of 110 PageID 323Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 84 of 110 PageID 323
App085Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 85 of 110 PageID 324Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 85 of 110 PageID 324
App086Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 86 of 110 PageID 325Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 86 of 110 PageID 325
App087Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 87 of 110 PageID 326Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 87 of 110 PageID 326
App088Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 88 of 110 PageID 327Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 88 of 110 PageID 327
App089Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 89 of 110 PageID 328Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 89 of 110 PageID 328
App090Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 90 of 110 PageID 329Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 90 of 110 PageID 329
App091Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 91 of 110 PageID 330Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 91 of 110 PageID 330
App092Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 92 of 110 PageID 331Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 92 of 110 PageID 331
App093Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 93 of 110 PageID 332Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 93 of 110 PageID 332
App094Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 94 of 110 PageID 333Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 94 of 110 PageID 333
App095Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 95 of 110 PageID 334Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 95 of 110 PageID 334
App096Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 96 of 110 PageID 335Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 96 of 110 PageID 335
App097Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 97 of 110 PageID 336Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 97 of 110 PageID 336
App098Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 98 of 110 PageID 337Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 98 of 110 PageID 337
App099Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 99 of 110 PageID 338Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 99 of 110 PageID 338
App100Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 100 of 110 PageID 339Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 100 of 110 PageID 339
App101Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 101 of 110 PageID 340Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 101 of 110 PageID 340
App102Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 102 of 110 PageID 341Case 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
App103Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 103 of 110 PageID 342Case 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
App104Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 104 of 110 PageID 343Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 104 of 110 PageID 343
App105Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 105 of 110 PageID 344Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 105 of 110 PageID 344
App106Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 106 of 110 PageID 345Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 106 of 110 PageID 345
App107Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 107 of 110 PageID 346Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 107 of 110 PageID 346
App108Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 108 of 110 PageID 347Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 108 of 110 PageID 347
Exhibit C
App109Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 109 of 110 PageID 348Case 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) <[email protected]>
Cc: Elizabeth Brehm <[email protected]>; Gabrielle Palmer <[email protected]>
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) < [email protected] >
Sent: Thursday, November 4, 2021 11:07 AM
To: Gabrielle Palmer < [email protected] >
Cc: Aaron Siri < [email protected] >; Elizabeth Brehm < [email protected] >
Subject: RE: Public Health and Medical Professionals for Transparency v. FDA,, 4:41-cv-01058-P (N.D.
Tex. 2021)
App110Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 110 of 110 PageID 349Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 110 of 110 PageID 349