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CRMTS 6909 Cover Letter - Wilate, December 23, 2008
Our Reference: CRMTS #6909, STN 125251/0/29
Attention: Mr. Stanley Ammons
c/o U.S. Associate for Octapharma
121 River Street, 12th floor
Hoboken, NJ 07030
Dear Mr. Ammons:
We have reviewed your submissions under STN 125251/0/29, CRMTS #6909, for von Willebrand Factor/Factor VIII Concentrate (Human) (VWF:RCo) [WILATE], to seek agreement with FDA on the proposal for the use of a modified analytical method to measure the relevant concentrations of VWF:RCo in plasma after WILATE infusion, and for potency estimations of VWF-containing concentrates. The proposal relates to items #1 and #31 of the Complete Response letter dated January 8, 2008. You also sought concurrence from FDA to resume previous advanced discussions on the acceptability of Octapharma's European efficacy data for the licensure of WILATE in the United States.
FDA sent a fax on December 8, 2008, responding to the questions posed in your meeting package. Octapharma notified FDA on December 10, 2008 that after reviewing the responses you wish to cancel the face-to-face meeting with FDA scheduled for December. 12, 2008 from 9:30 a.m. to 11:00 a.m.
In lieu of the meeting, enclosed is a copy of the December 10, 2008 fax, which will serve as the Official Meeting minutes.
If you have any questions, please contact Pauline Cottrell of this office at (301) 827-6162.
Basil Golding M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research