`24 May 2006
`
`Attendees:
`
`1. Primary Objective
`-
`defmed the primary objective of this meeting is to establish the timeline and
`•
`responsibilities for the delivery of the two BG 12 protocols: L09-MS-301 (monotberapy,
`double-blind, placebo-controlled) and 109-MS-302 (3-Ann, double-blind, placebo(cid:173)
`controlled, reference comparator). The deadline for obtaining CTRB Chairperson (C.
`Bozic) approval for the two protocols is 13July06, as these protocols will be included in tbe
`End of Phase 2 (EOP2) submission to the FDA.
`o Note: for l3July06 delivery date, the protocols need only have the approval of the
`CTRB Chairperson . Signature is nor required at tbat time.
`o Final sign-off of the protocols will take place following FDA review and comment
`from the EOP2 Meeting (estimated to take place in August 2006).
`• RL clarified the protocols must be approved/completed no later than NOON on 13July06 in
`order to complete the EOP2 submission package. The EOP2 submission is scheduled to go
`to the FDA on 14July06.
`• RL advised the team that Regulatory anticipates the BG 12 EOP2 meeting will be scheduled
`some time during between the dates of August 15-24, 2006.
`
`Page 1 of2
`
`Biogeo Exhibit 2115
`Coalition v. Biogeo
`IPR2015-01993
`
`
`
`Page 2 of 2
`
`Page 2 of 2
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