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`CONFIDENTIAL
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` AGENCY TELEPHONE CONTACT REPORT
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`PRODUCT: BG000012
`
`Application #: IND 73,061
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`DATE/TIME OF CONTACT 26 April 2006
`OUTGOING:
`INCOMING:
`
`AGENCY REPRESENTATIVE(S):
`James Reese, Project Manager 301-796-1136
`Biogen Idec PARTICIPANT(S): Tammy Sarnelli
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`
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`SUBJECT:
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`Submission of an End of Phase 2 Meeting Request While on Clinical Hold
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`I called Jim Reese to inform him that Biogen Idec’s responses to the Clinical Hold have a target
`submission for late next week. He thanked me for informing him about the timing of this submission.
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`I took the opportunity to ask Jim if he knew of any regulations that would prevent us from requesting
`an End of Phase 2 meeting while we are on clinical hold. Jim stated that we are entitled to request
`any meeting at any time, whether we are on clinical hold or not.
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`He did caution that FDA could deny our request, but they would need to provide a clear explanation
`of the reason(s) for the denial (e.g. the meeting request did not meet the requirements put forth for
`Formal Meetings). He also stated that with FDA’s limited resources, we would not be able to have
`more than one EOP2 meeting. I clarified for Jim that it is our intention to have one EOP2 meeting
`whereby we would supply the data from a completed Phase 2 study (C-1900) and provide the Phase
`3 study designs for FDA feedback.
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`Jim reminded me that we couldn’t begin a long-term study in the US until results from the 12-month
`non-human primate toxicology study have been submitted. I confirmed that this was our
`understanding from the Pre-IND meeting.
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` thanked Jim for his time and the call was ended.
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` I
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`ACTION(S) REQUIRED
`FOLLOW-UP ACTIVITY
`RESPONSIBILITY
`Core Team to define timeline for EOP2 meeting
`T. Sarnelli et al.
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`DATE DUE
`May 2006
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`cc: Regulatory CMC, Regulatory Cambridge, Regulatory UK, BG12 Program Team
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`Page 1 of 1
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`Page 1 of 1
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`Biogen Exhibit 2381
`Coalition v. Biogen
`IPR2015-01993
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`
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