`
`March 11, 2008
`
`Center for Drug Evaluation and Research
`Food and Drug Administration
`5901 -8 Ammendale Ad
`Beltsville, MD 20705-1 266
`
`Attn: Russell Katz, MD
`
`RE: INO 73,061: BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Response to Request for Information
`Serial No.: 0047
`
`Dear Dr. Katz:
`
`This submission contains the final report from a 2-year carcinogenicity study in rats
`administered BG00012 (Report No. P00012-04-11), entitled:
`
`"A Two Year Oral (Gavage) Carcinogenicity Study in Rats with BG00012".
`
`Page 1 of2
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`Biogeo Exhibit 2283
`Coalition v. Biogeo
`IPR2015-01993
`
`
`
`biogen idee
`
`Should you require any additional information, please contact Tammy Sarnelli, Director,
`Regulatory Affairs at 617-679-3513. The contact for technical aspects for this
`, Senior Director, Regulatory Affairs Operations at 617-679-2416.
`submission is
`
`Senior Vice President, Regulatory Affairs
`Phone (617) 679-3783
`
`Fax (617) 679-3170
`
`Siogen Idee 11 Ga•llood!-JP Cwnt.r C.ltn\)tttlyc, MA 02142 Plwnt: 617 67H ::000 wv.w.b1ogenodec.com
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`Page 2 of2
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