`109-315-301 and 109-MS-302
`
`Thursday, 22nd February 2007
`
`DlS'l'RlBL"1'l0N / A'l"1’EE\'DEES
`
`BIIB Attendees
`
`!!a”ac|1cr
`lama “in amaneni
`
`Minhua Yan
`
`Kate Dawson E
`
`Nmncs in BOLD zmended Ihi» 1llc.‘c:l1Il_E
`
`Clinical Update:
`109.\'lS30l Study Status Lpdate
`0
`129 sites Spousal nppmvcd
`o
`155 PSSV cmnplcled (13 sites in rccruilmcnl and 43 in follow up)
`o
`['8 sire number has been increased from 1',’ to 24 I0 rcdncc overlap
`
`BG12 SMT Meeting Minutes
`
`Page 1 Of 4
`
`Biogen Exhibit 2203
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`Australia:
`
`0 I update: 2 patients have been screened.
`
`Post—mr-etina note: FPI within the next few weeks (8th March possibly)
`
`Belgium:
`0 Regulatory approval received
`
`0
`
`5th March.I 6thMarch.-: 8th March.
`SIV dates confnmed
`: 301 1Mar'eh
`2: 13th March.
`o Awaiting Central Ethics approval - expected by 28th Feb
`Post—meeting note - Central Ethics approval received Friday 2nd March
`
`New Zealand:
`
`0 SIV dates Mid to End March
`
`9|_hs_I;
`0 UK - Regulatory approval received
`-
`Submissions made in: Czcch Republic. Slovakia. Austria & Germany
`o Contining to do feasibility in backup cormtries
`0 Canada & Russia - Potential SIV dates in April
`
`109318302 Study Status Update
`0
`101 sites Sponsor approved
`0
`137 PSSV completed (45 in recruitment. 87 in feasibility)
`
`Canada:
`7-; Potential FPI site
`
`Russia:
`
`0 Regulatory Submission made
`o Have received Central ethics and Pliannacological committee approval
`0
`Potential SIV dates in April - dependant on approval
`
`
`
`Other:
`
`0 Regulatory Submission: Canada. Czech Republic. Spain have been completed
`0 Belgilnn & Hungary submission are currently being subnritted
`
`INEC Members Update
`o
`3 nienibers: 1 outstanding contract
`[NEC high-level timeline & update -
`0 Weekly meeting with. (Scheduled on Wednesdays at 11.00am EST)
`— Status update including system development. eonnnunications with INEC etc
`0 Review of portal meeting (Scheduled for 22nd Feb at 1.00pm EST). portal should be available after
`meeting
`0 - representative will be presenting at the Investigator‘ nreeting; Training will include;
`- Communication process with TNEC‘ and how! is involved
`Sites currently have instructions on how to sen information to JNEC when there is a relapse. Currently
`this states information is to be sent to’. - have been instructed to amend these instructions
`and will be sent to. for distribution
`
`0
`
`BG12 SMT Meeting Minutes
`
`Page 2 of 4
`
`
`
`Data Management Update
` 301 & 302 CRFs including the questionnaires are available at the warehouse
` V2 for 301 and V1 for 302
`
`DSMC update & Charter
` First meeting was held on 21st February 2007
` Minor changes will need to be made to DSMC charter
` DSMC are interested in seeing efficacy data – they requested additional tables
`Action:
` to send DSMC Charter out to team within the next couple of weeks
`
`Investigator meeting reminder
`
`First Investigator meeting to be held 26th & 27th February in Dublin
`
`Meeting planners are coordinating all details
`
`Presentations are currently being finalized
`
`April meeting invites to be sent in the next couple of weeks
`
`Boston meeting - to be held in June. Currently discussing possible location due to AAN also being
`held in Boston
`
`BG12 SMT Meeting Minutes
`
`Page 3 of 4
`
`
`
`
`
`BG12 SMT Meeting Minutes
`
`
`
`8th February 2007
`
`Page 4 of 4
`
`
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