`
`Cente' 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
`Serial No.: 0007
`Response to Non-Hold Issues
`
`Dear Or. Katz:
`
`Reference is made to the IND clinical hold letter for BG00012 dated April1 9, 2006, which listed
`both Clinical-hold and Non-hold deficiencies. Biogen Idee submitted a complete response to the
`clinical hold issues on May 12, 2006 and was informed on June 14, 2006 by the FDA that the
`clinical hold for INO 73,061 has been lifted.
`
`In response to the non-hold deficiencies identified in the April 19, 2006 letter, the following
`information is included In this submission:
`
`I.
`2 .
`
`Responses to IND non-hold deficiencies
`Copy of the revised Investigator's Brochure along with Summary of Changes
`
`In addition, a copy of the final protocol for Study 1 09-HV-1 01 (a copy of the draft version was
`submitted in the initiai iND) has been included.
`
`This submission is provided electronically as an amendment to the electronic IND.
`
`Should you require any additional information, please contact Tammy Sarnelli, Associate
`Direcbr, Regulatory Affairs at617-679-3513. The contact for technical aspects for this
`
`submission is··························
`
`Biogen Idee 11 Cambndgc Cenler Cambn~e. \1A02142 !'hone 61? tl?9 2000 www.biogerri oc-c.wm
`
`Page 1oft
`
`Biogeo Exhibit 2225
`Coalition v. Biogeo
`IPR2015-01993
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