`Friday, 2 February 2007
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`DISTRIBUTION l ATTENDEES
`
`Committee Members
`
`
`
`Bloien Idec
`a 6
`awson
`Phill Gallacher
`
`
`
`Names 1n BOLD attended this meeting
`
`
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`Page 1 0f 3
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`Biogen Exhibit 2212
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`INEC Assessment Documentation Review
`
`
`
`
`
`
`
`
`The INEC assessment documentation was shared with the Advisory Committee.
`has been hired to serve as the administrator and monitor of the
`
`INEC.
`The Advisory Committee was asked if the information provided would be enough for an INEC
`member to confirm if a patient has had a relapse.
`o
`Consistency is the goal; the clinical team wants the decision to be made using the same
`body of information.
`o
`Of the data we are already capturing, what would an independent body need to make an
`assessment?
`It was suggested the clinical team speak to neurologists who have been on this type of committee
`before.
`o
`
` were suggested as possible contacts.
`
`Study Update
`
`
`
`o
`
` provided the committee with a high-level summary of study status:
`119 sites have been approved to participate. One site in Slovakia declined after being
`approved.
`
`109MS301 Advisory Committee 2 February 2007
`
`Page 2 of 3
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`
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`o
`o
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`The clinical team would like to add 41 more sites to the study to meet timelines.
`The timeline will be amended to reflect study start-up challenges.
`
`109MS301 Advisory Committee 2 February 2007
`
`Page 3 of 3
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