`
`. FOOD DRVG ADMINISTRATION
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`10903-NEW HAMPSIDRB A VENUE
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`Page 1 of2
`
`Biogen Exhibit 2296
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`JAN-27- 1996 10:03
`
`P.02/02
`
`IND 73,061
`
`Tammy Samelli
`Biogen Idee
`
`Please refer to your Investigational New Drug Application (IND) submitted under section
`505(i) of the Federal Food, Drug, and Cosmetic Act for BG00012 (Dimethyl Fumarate)
`capsules.
`
`We also refer to your June 23,2006, correspondence requesting an End of Phase 2
`meeting to discuss the clinical development ofBG00012.
`
`Based on the statement of purpose, objectives, and proposed agenda, we consider the
`meeting a type B meeting as described in our guidance for industry titled Formal
`Meetings with Sponsors and Applicants for PDUFA Products (February 2000). The
`meeting is scheduled for:
`
`Date: August 30, 2006
`Time: 3:00- 4:30PM Eastern Time
`Face to Face
`
`CDER participants:
`Russell Katz
`Marc Walton
`Eric Bastings
`J aneth Rouzer Kammeyer
`Paul Roney
`Lois Freed
`Martha Heimann
`Ramana Uppoor
`Kun Jin
`James Reese
`
`If you have any questions, call James Reese, Regulatory Project Manager, at (301) 796-
`1136
`
`Jim Reese
`
`Page 2 of2
`
`TOTAL P . 02
`
`
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