`
`109-MS-301 and 109-MS-302
`
`Thursday, 21*‘ September 2006
`
`DISTRIBUTION I ATTENDEES
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`39 awson
`
`E naamanen
`ang
`
`Names in BOLD attended this meeting
`
`Biogen Exhibit 2241
`
`Coalition V. Biogen
`IPR2015—01993
`
`
`
`MINUTES
`
`Pl'OtOCOl Status 8: ICF * DEVGIO mentIA roval Timeline
`
`1. Pl'OtOCO|
`
`o Carmen Bozic to si n off toda
`
`Action:- KD, MY and“ to also sign protocol
`o Lead investigator preferably Prof. to be confirmed.
`o Ongoing discussions regarding whether to use Lyophilised or Liquid (PFS) Avonex for
`the study, depending on availability.
`Action. to confirm with] regards Avonex Lyo / PFS
`Action: MY to have internal discussions regarding how the relapse rates are calculated for
`patients on Avonex open label.
`
`2. lCFs
`
`o Draft lCFs MRI, EDSS) reviewed, comments being incorporated by medical writing
`
`i).
`
`o Finalise 4 ICFs: models (Intl, NA), suspected Relapse and sustain progression for
`tomorrow.
`Action:- to sign off model ICF for EU, Ratna to sign off NA model ICF on Friday 22"“
`September.
`Action:
`Action:
`
`and KD to also sign off model lCFs.
`to send comments on ICF to‘
`
`Page 2 of 7
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`
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`CRO Kick off meeting
`Finalised date and venue to 18th and 19th October in UK office
`ction: MY to discuss with
` whether to attend in person
`
`A
`
`Investigator Meetings
`Australian mini investigator meeting planned in November (either week of 13th November
`
`or 20 h November) details TBC.
`Large investigator meeting planned for last week in Jan / last week in Feb in Dublin.
`Details TBC.
`
`
`
`Page 3 of 7
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`Page 4 of 7Page 4 of 7Page 4 of 7
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`Page 4 of 7
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`Page 5 of 7Page 5 of 7Page 5 of 7
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`Page 5 of 7
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`CRO Kick Off Meeting
`
` to distr bute agenda and attendee
`details to the team when details have been
`confirmed.
`MY to discuss with
`person
` to follow up with meeting planner for
`ideas on venues close to a large
`international airport
`
` whether to attend in
`
`MY
`
`CRO kick off moved from mid-Sept to 18th and
`19th October
`
`07th Sept
`
`Pending
`
`21st Sept
`
`07th Sept
`
`Venue confirmed as Dublin
`
`Complete
`d
`
`CRF
`Sample drug kits will be brought to the SMT
`next week to aid discussion
`
` /
`
`07th Sept
`
`Pending
`
`Pending
`
`R
`
`R
`
`R
`
`R
`
`R
`
`R
`
`R
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`Page 6 of 7
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`Page 7 of 7
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