`109-MS-301 and 109-MS-302
`
`Thursday, 07 September 2006
`
`DISTRIBUTION I ATTEN DEES
`
`
`
`Kate Dawson
`
`Ratna Lingamaneni
`
` Minhua Yang
`
`Names in BOLD attended this meetin
`
`Study Status
`
`MINUTES
`
`1. Protocol changes (as per! email)
`at
`Annual Relapse Rate
`years will be the primary endpoint. Proportion relapsing will move
`to a secondary endpoint.
`Increase in number of patients is off-set by decrease in
`Addition of 480 mg dose arm.
`changing the endpoint. N stays about the same.
`301 becomes a 1:121, 302 becomes a 1:1:1:1
`Avonex will be offered as rescue therapy (after 48 wks) once a patient has had tw_o relapses
`("banking" ofa relapse will be removed, now relapses will count from the moment a patient
`enters the trial).
`
`BG12 SMT Meeting Minutes
`
`07 September 06
`
`Page 1 of 5
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`Biogen Exhibit 2234
`Coalition v. Biogen
`IPR2015-01993
`
`
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`CRO Kick-Off Meetin/Investiator Meetin Udate
`
`- Kick off is tentatively planned for October 3"’ and 4"‘ in the UK office. Date will depend on when
`protocol is signed off.
`Action: - to update team on details
`a
`Investigator meeting planned for end of January/ early February, depending on protocol sign
`off.
`
`Action: - to follow up with meeting planner for ideas on venues close to a large international airport.
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`Page 2 of 5
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`ACTION ITEMS
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`ICF to be modified due to results from EOP2
`meeting
`
`CRO kick off moved from mid-Sept to first week
`Oct
`
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