`
`109-MS-301 and 109-MS-302
`
`Thursday, 11"‘ January 2007
`
`DISTRIBUTION I ATTENDEES
`
`BIIB Attendees
`
`Minhua Yan
`
`I
`
`33C er
`
`a na
`
`ingamaneni
`
`awson
`
`
`
`ate
`
`Names in BOLD attended this meeting
`
`MINUTES
`
`109MS301 Study Status Update — P Gallacher
`o
`94 sites have been approved to participate to date.
`Australia
`
`o ‘: Drug was released to the site earlier this week.
`o
`FPI targeted for February. ‘ has two potential patients, and‘ is following up
`with the site.
`Canada:
`
`o -1 The SIV was pushed out to 18"‘ Jan. Final EC approval is still pending.
`
`BG12 SMT Meeting Minutes
`
`Page 1 Of 6
`
`Biogen Exhibit 2220
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`New Zealand:
`
`First EC submission made for‘ site.
`-
`Other:
`
`o The clinical team is moving ahead with France
`if we add these two
`- The clinical team is moving ahead with feasibility in Bulgaria and Romania.
`countries, we will need to modify the quality metrics contract so we can get the SF36 to-
`
`109MS302 Study Status Update -_
`
`o participate to date.
`49 sites have been approve
`o
`. Target for FPl is has shifted from Belgium to Canada based on questions raised by the
`regulatory authority in Belgium. The FPI site(s) are currently being identified.
`
`c We are waiting for EC meeting datesf in the hopes to activate a site
`
`arc .
`in February, however FPI will likely be in
`has agreed to be the Coordinating Investigator in Belgium.
`Feasibility has started in Romania, Bulgaria and Italy, and we have also increased the number of
`US sites to 70.
`
`o
`
`contacted Bl|B Med Affairs to find out if they can give us more sites in the US.
`o
`
`confirmed that_ji is going to do 301 study first.
`o
`0 Copaxone availability: Copaxone to be shipped to BllB tomorrow, need about 4 weeks to get it
`prepared, targeting 13 February for shipping to sites in Canada if necessary.
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