BG00012 Proposed End of Phase 2 Briefing Document
`
`Activity
`
`•
`
`•
`
`Line reviewed first drafts complete
`Publish
`Team Review (authors and regulatory)
`Review
`Comment incorporation
`meeting
`Meeting request submission
`Comment incorporation
`•
`Publish
`Cross-Functional review:
`
`•
`
`Comment incorporation
`Publish
`VP review/approval
`
`Date
`
`June 13
`June 14-15
`
`June 16-22
`June 23
`
`June 26
`June 26-27
`June 28-29
`June 30 – July 7
`
`July 10-14
`July 17
`July 18-20
`
`CMC???
`Comment incorporation
`Content Final
`Regulatory Operations (submission
`preparation)
`Submit EOP2 briefing document
`End of Phase 2 meeting
`
`July 21-25
`July 26
`July 26-28
`
`July 28
`August 30
`
`Duration
`(working days)
`
`2 days
`
`5 days
`1 day
`
`2 days
`2 days
`5 days
`
`5 days
`1 day
`4 days
`
`3 days
`
`3 days
`
`3 – 4.30 PM
`
`Page 1 of 1
`
`Biogen Exhibit 2366
`Coalition v. Biogen
`IPR2015-01993
`
`
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