`25
`2006
`
`Cara Lansden, Tammy
`
`Page 1 of2
`
`Biogeo Exhibit 2124
`Coalition v. Biogeo
`IPR2015-01993
`
`
`
`3. Scenario planning for regulatory feedback
`
`I
`o The three EU scientific agencies with meeting in June (Sweden 6/12,
`Netherlands 6/21 , UK 6/27) will all receive the same briefing
`document, no time to change between them
`o Spain meeting to be in July, could be used for validating
`contingency plan if trial design needs to be changed
`o France could be added if additional fallback guidance is
`needed
`o Four key issues that we should expect to receive feedback:
`o Choice of endpoint, no direct comparison between active
`comparator and BG-12, choice of Copaxone as comparator
`(including lack of double dummy placebo) and using subset
`of patients for MRI
`If we receive consistent feedback from EU agencies we should
`change plan accordingly prior to receiving advice from FDA
`o Need to revisit discussion at next week's Program Team meeting to
`finalize recommendation on our approach to mixed feedback from
`EU agencies
`
`o
`
`une,
`
`to request
`targeting mid-August for actual meeting
`o Timeline to complete draft of FDA Briefing document by June 13,
`then iterate and review for mid-July submission
`o Timeline could be impacted if we make changes based on EU
`agency feedback
`o Need contingency plan with clear decision point to make changes to
`clinical development
`-
`· Cara and Tammy will review clinical and regulatory timelines,
`~sit at next week's Program Team meeting
`
`o
`
`4. Planning for FDA EOP2 meeting
`
`Page 2 of2
`
`
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