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`109-MS-301 and 109-MS-302
`
`Thursday, 14”‘ December 2006
`
`DISTRIBUTION I ATTENDEES
`
`BIIB Attendees
`
`
`
`Minhua Yang
`
`
`lawacuer
`!a!na lmgamaneni
`
`ate
`
`awson
`
`
`
`MINUTES
`
`FDA Response to SPA Submission -9
`
`-
`
`IS was more of a process check call and reminder that
`.
`BIIB team had a telecom with F
`the 301 & 302 SPA submission does not fall under the SPA/Protocol review criteria as we do
`
`not meet all the requirements i.e. Toxicology & OTC data. Hence we could either
`o Withdraw protocol from SPA submission
`0 Or have the protocols put on clinical hold
`
`o
`
`BIIB decided to withdraw the protocols and received comments from FDA (received on
`Monday 11“ Dec 2006)
`o Comments are currently being reviewed by sub teams and will be addressed within the cardiac
`risk plan
`
`BG12 SMT Meeting Minutes
`
`14 December 06
`
`Page 1 Of 5
`
`Biogen Exhibit 2213
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`-
`
`Feedback to the SMT will be given by early January 2007 (Kate Dawson — may review and
`feedback sooner if needed)
`o Clinical Team is to continue to work towards the current submission deadlines. They will be
`notified if any changes occur
`
`a Responses from Health Canada
`
`to me CMC questions were received two weeks ago.
`
`These have all been addressed by BIIB
`o HC had also requested clarifications to be made to the ICF. These have been completed and
`sent to the reviewer (13"‘ Dec 06). Approval has also been received
`If nothing
`BIIB are waiting for any additional questions (deadline to receive any - 15"‘ Dec 06).
`is received then should receive a letter from HC with their decision by Monday 18“ Dec 06.
`
`a
`
`
`
`109MS301 Study Status Update — P. Gallacher
`o
`PSSV update:
`r:
`95 PSSV completed
`c
`12 PSSV scheduled before Christmas
`
`o
`e
`
`33 PSSV to be scheduled - some will take place before New Year but not all
`140 Total potential PSSV
`
`Australia:
`
`o Site Initiation Visit SIV at
`
`site re-scheduled for 2"” or 3"‘ Jan
`
`
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`Page 2 of 5
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