`
`Center for Drug Evaluation and Research
`Food and Drug Administration
`5901 -B Ammendale Rd
`Beltsville, MD 20705-1 266
`Attn: Russell Katz, MD
`
`RE:
`
`IND 73,061 : BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Information Amendment: Study C-1903- Clinical Study Report
`Serial No.: 0008
`
`Dear Dr. Katz:
`
`Biogen Idee, Inc. is submitting to the IND the final clinical study report for Phase 1 study (C-
`1903), entitled:
`
`"A Single-Center, Randomized, Crossover Study to Investigate Possible Food Effects on
`BG00012, When Administered as Single Oral Doses in Healthy Volunteers" .
`
`·------------------
`
`Blogen Idee Inc. Is also submitting new Investigator information for the following study:
`
`1 09-HV-1 01: "A Single-Center, Randomized, Blinded, Placebo- and Active-Controlled
`Study to Evaluate the OTc Interval Prolongation Potential of BG00012 When
`Administered to Healthy Volunteers."
`
`Should you require any additional information, please contact Tammy Samelli, Associate
`Director, Regulatory Affairs at 61 7-679-3513. The contact for technical aspects for this
`submission i
`, Senior Director, Regulatory Affairs Operations at 617·679-2416.
`
`Senior Vice President, Regulatory Affairs
`Phone (61 7) 679-3783
`FAX (61 7) 679-4459
`
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`Biogeo Exhibit 2328
`Coalition v. Biogeo
`IPR2015-01993
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