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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telephone Call from CBER RE Wilate, November 5, 2009

From: Serro, Xenia [xenia.serro@octapharma.com]
Sent: Thursday, November 05, 2009 8:46 AM
To: Cottrell, Pauline
Cc: Rangetiner, Barbara; Ammons, Stanley
Subject: RE: Telephone Call from CBER RE Wilate (STN 125251/0)

Dear Ms. Cottrell,

Thank you for the telephone conversation right now.

Please be informed that we choose the manual method for VWF:RCo assay as submitted in the original BLA in December 2006 for labeling purposes.

In case you have any further questions please do not hesitate to contact us.

Kind regards,

Xenia Serro
Regulatory Affairs Manager
octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235
A-1100 Vienna, Austria
Phone: +43-1-610 32-1263
Fax: +43-1-610 32-9122
e-mail: xenia.serro@octapharma.com