`l09.\1S301, l09MS302 & l09MS303
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`Tuesday I8 Janlmry 2011
`D.“ SMT Meeting Minutes
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`l)lS'l‘RlBUT[()1'\' / .\’l"l‘l".I\'l)FF.S
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`BIIB Attendees
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`Jolm O‘Gm1nan
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`Minhua Yun
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`Kate Dawson
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`Phill Gallachcr
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`Tannnv Sm1n:lli
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`Names in BOLD attended Ibis meeting
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`BGO0012 SMT Meeting Minutes FINAL 18-Jan-2011
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`Page 1 0‘ 4
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`Biogen Exhibit 2223
`Coalition v. Biogen
`IPR2015-01993
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`301i'302l303 Timelines
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`q distributed the updated Final DBL timelines to the SMT. The 302 Final DBL timelines
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`were revise
`0 account for the new LPLV date of 06Jun11 (previous LPLV was 20May2011). The
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`Timeline remains 6 weeks from LPLV to DBL, however, many of the activities and durations have
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`shifted from the previous timelines. - explained that she needed to add additional days to some
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`activities and remove days from other activities and thus these do not match up with the predecessors
`and durations of the 301 Final DBL timelines.
`confirmed the differences between 301 and 302
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`timelines are not due to errors, but expected to ave differences given the 301 DBL is 7 weeks and 302
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`DBL is 6 weeks. Minhua asked to add in activities related to reconciliation of 303 data listings against
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`both 301 and 302 data listings as well as adding in an additional 3”’ review prior to the Data Audit.
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`ACTlONi to update the timelines and redistribute to the SMT for final review.
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`Trend of increased re:gue[y rate
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`E will present on the query trend for 301/302i'303 and revisit the Quality Management P|ani'Gap
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`Analysis for BG12 at the SMT on 01 February.
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`POST MEETING NOTE:
`to still provide an update on the increased re—query rate trend as this is
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`a separate topic from
`query trending (region/countylsite).
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`Unblindin after Database lock — Informin Sites of treatment arm
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`in follow up to an EC annual renewal report, the question arose if and when would we notify sites and
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`pts of their treatment arm on 301 and 302. Per the 303 protocol, if a favorable dose is determined from
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`301/302 then all pts would then be switched to that dose in 303.
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`BGO0012 SMT Meeting Minutes FINAL 18-Jan-2011
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`Page 2 of 4
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`Page 3 of 4
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`Page 3 of 4
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`Page 4 of 4
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`Page 4 of 4
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