throbber
From:
`Sent:
`
`To:
`
`CC:
`
`cara lansden/cambridge/biogen;nsf;cara.lansdenflibiogenidec.com;smtp
`Tue Oct 25 2005 15:54:43 EDT
`n
`”Am“ Inmlrorllnnrlnnllnlnunnfffikinlmnirlnn‘ n
`uuuun Amyl\yal ‘uuuv‘u V‘Vb"“\?¥ unvbynnuwu.5uunu
`
`yang/cambridgc/biogcni’rjlbiogcnidcc:
`
`alison tibbettsfcambridge/biogen@biogenidec;anelie fanchini/londowbiogen@biogenidec;ann dodds-
`frerichs/cambridgeI’biogenaj‘lbiogenidec;christine giacobbe/cambridge/biogenaflbiogenidec;c11ristop11er
`Ienlioor/cambridge/biogen@biogenidec:cun hoffman/cambndge/biogen@biogenidec:dale
`spriggs/c ambridgefbiogen‘fq‘lbiogenidec ;damon demady/cambridge/biogen@biogenidec ;ed
`berkhofflcambridge/biogenéiibiogenidecxric page/cambridge/biogenaiT-biogenidec;frances
`lyIni/cambridge/biogen@biogenidec;rachel lebouteiller/london/biogen@biogenidec:rama
`lingamancni/cambridgc/biogcn@biogcnidcc;susan goclzi’cambridgc/l)iogcnrrrfibiogcnidcc:sycd
`saiiad/cambridge/biogen@biogenidecJammy samelli/cambridge/biogen@biogenidec:
`
`Subject:
`
`Information Update - Description has changed: BG 12 MS CDT
`
`BGl2 MS C DTs
`
`DATE2Wednesday
`TIME: 12noon EDT, 9am PDT, 5pm UK
`ROOM: Bio 4, Room 4902
`
`Agenda:
`C-1900 Unblinding Plan - R. Lebouteiller
`Phase 3 Strategy - Follow up discussion
`
`@
`
`013m Unblinding plan flow chalt 25 Oct Didoc
`
`Dial-In Information
`
`Domestic Dial-In Number: (866) 309-3684
`International Dial-In Number: (706) 758-0773
`Conference Code: 6176792658
`Cara will dial in as leader.
`
`Page 1 of 2
`
`Biogen Exhibit 2090
`
`Mylan v. Biogen
`IPR 2018-01403
`
`

`

`Flow Diagram of C4966 unbiinding Process
`
`Database lock for the Treatment phase study C-1 900
`()2 Nov ()5
`
`
`
`Transfer of responsibilities to a second blinded set of
`statisticians and programmers that assume routine stats
`
`responsibilities for the extension phase (SMC, SMT)
`
`Initial unblinding and analysis of 01900 Treatment
`phase — Mon 21 Nov 05 — Week 47 -
`
`2 statistician (Minhua Yang, Frances Lynn
`and 3 programmers (Sarah McLaughlin,
`Huijuan Xu and Tim Tian) are unblinded.
`
`Review of analysis by 2 Medical Directors (Alfred
`Sandroek, Gilmore O’Neill) — Wed 23rd Nov— Week 47
`GON to grouped results ONLY.
`
`Presentation of analysis to members of senior
`management committee (Whaijen 800, Laura
`Meyerson, Cannen Bozic, Glyn Belcher, Dale Spriggs)
`Mon 28 Nov -Week 48 - By Gilmore O’Neill
`
`.
`.
`_
`.
`.
`Approxnnately 12 mdrvrduals unblmded ‘0
`data rCSUIIS
`
`Presentation of analysis to Neurology SBU Bob
`Hanan, HP Hasler by GON — Tues 29 Nov -
`
`Presentation ofthe grouped results to C- 1900 Advisory
`Committee (Eflicacy only) and to the C-l900 SMC
`(Safety data only) by GON — Wed 30 Nov -
`
`Approximately 23 individuals unblinded to
`data results
`
`
`
`
`
`Dec -
`
`Presentation ot'the grouped results (Efficacy only) to
`the Program Team By Gilmore O‘Neill
`- Thu 015'
`
`
`
`
`Presentation ot'the grouped results to 2 individuals from.
`Regulatory Affairs and 1 Medical writer for Gemtan
`MAA update and MS IND Filing, and IB update,
`respectively — by GON — Thu 0 1“ Dec
`
`Presentation ot'the grouped results to Furnapharm By
`Gilmore O'Neill - Week 49 -
`
`
`
`DOC ‘5 00/ No GO Meeting — Mon 12 Dec —
`
`
`
`Presentation oftlte grouped results (Efi‘ieacy only) to
`C-l900 Investigators by teleconference — Week 50 —
`
`ONLY in case ofa press release.
`
`Page 2 of 2
`
`

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