`109-MS-301 and 109-MS-302
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`Thursday, 9”‘ November 2006
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`DISTRIBUTION I ATTENDEES
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`!a“ac“er
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`awson
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`!atna lmgamaneni ate
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`ulnnua Lng
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`Page 1 Of 5
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`Biogen Exhibit 2206
`Coalition v. Biogen
`IPR2015-01993
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`109MS301: Study Start-up Update -H
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`re urned
`245 CDAs have been sent out, 1
`-
`192 SRQS have been sent out. 101 returned
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`68 SRQS reviewed by BIIB, 46 sites have been approved to participate
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`Australia:
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`7? has not yet confirmed initiation visit date
`er potential Australian sites are reviewing the budget
`-
`o
`EC submission dates for‘ and -are pending
`New Zealand:
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`- ‘EC central submission is scheduled for 14 Nov
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`to contact Imperial Graphics to check if there is a specific VAS for NZ
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`Action:
`Canada:
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`CTA submission completed 7 Nov
`-
`South Africa
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`- There are particular ethics committees in South Africa that will not accept the 1996 Dec of
`Helsinki. only the 2000 version.
`If we ask sites to use other ethics committees that we are not
`familiar with, we run the risk they will not accept the 1996 version.
`Action: BIIB clinical/commercial to discuss and provide guidance to]
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`109MS302: Study Start-up Update --
`o
`195 CDAS have been sent out, 164 returned
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`158 SRQs have been sent out, 55 returned
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`Page 2 of 5
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`Page 3 of 5
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`Page 3 of 5
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`ACTION ITEMS
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`Reg to confirm date for Health Canada
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`28 Sept
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`a
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`=_—-
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`
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`submission date for 301 & 302 ‘ Completed
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`Ekf“ "
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`A
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`"
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`I to Contact Imperial Graphics to get VAS
`_for Belgium by Friday 3 Ngv__
`I to distribute 301v1 Guidelines and 302
`CRFS and schedule review meetins
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`Completed
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`Completed
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`BG12 SMT Meeting Minutes
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`9 November 2006
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`Page 4 of 5
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`fi’?§1’9,’?"?,":9§ _
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`se
`I KD to develop telephone r
`I KD and
`questionnaire for 301 and 302.
`the team to consider whether to capture in
`the CRF_
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`.
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`On target for next week