`Friday, 19 January 2007
`
`DISTRIBUTION I ATTENDEES
`
`Committee Members
`
`
`
`Biogen ldec
`!ale REIWSOH
`Phlll Gallacher
`
`Names in BOLD attended this meeting
`
`- ‘ provided the committee with a high-level summary of study status:
`L.
`06 sites have been approved to participate in the study.
`There have been 4 Ethics Committee submissions with one approval (Canada)
`There have been 4 Regulatory submissions, with 2 approvals (Australia and Canada)
`Two sites have been initiated_ in Australia and— in Canada)
`Feasibility has begun in Romania and Bulgaria
`A
`m We are expecting feedback from the Belgian Ethics Committee next week
`
`109MS301 Advisory Committee 19 January 2007
`
`Page 1 0‘ 2
`
`Biogen Exhibit 2213
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`Any Other Business
`
`
`
`Clinical received feedback from the FDA on the SPA submission, which included a set of
`stipulations on the number of MRIs to be performed in the sub-study. The team initially thought they
`would have to increase the number of sites in the study to meet this criteria, however, after review,
`neither the number of sites nor the number of patients in the sub-study will be increased. A 6-month
`MRI may be added in as discussed previously in the upcoming amendment. The target is for MRIs
`
`Page 2 of 2
`
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