`
`Thursday 20 July ZU06
`
`Attendees:
`
` Rama Lingamanciii (RL ),
`
`
`
`
`
`0 Lnd 01' Phase 2 meeting scheduled for August 30 2006. Deadline for completion of
`thc protocols has been moved fomard due to the addition ofan 18-month interim
`analysis to both study dcsignsvprotocols 1 l0<).\-1S3()I and I00,\1S3()2).
`lhe DOPE
`pukugc iiicludiiig the final “approvcd“ drafts ofthc phase 3 protocol: will bu
`submitted to the FDA on Friday. '_’8Jul\'06.
`
`l’rutucol Status 8; Plans for Si-In-off
`
`Page 1 “*3
`
`Biogen Exhibit 2106
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`CRO selection
`
`0 - and) informed the team that. has been selected to submit safety
`x‘cpo1‘ts,»“d0cL1111cntalion to rcgulutoly agencies in Europe. - clzuificd that BUB US
`RcuuI;atox ' Affairs is res onsible for these submissions in . A.
`
`Page 2 of 3
`
`
`
`'3'
`
`ICFS
`
`l(.'l4s required: Model ICF, relapse ICF, genetic lCl-'. HIPPA (US) and MRI [C15
`l\‘-‘Iudcl ICF will be llualincd .I1flc1' l.llC PSP and [B are ztppmvcd. Tln: IB and PSP are
`due to be finalized and approved by l8Aug06.
`
`°2° V’endor selection
`
`Vendors needed for: IVRS, MR1 reading comer, C cnlral Labs (CCLS), ECG reading
`CCIHC1‘
`
`Page 3 of 3
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