08/18/ 2008 Email - RiaSTAP

Dear David,

Thanks for the response!

I just wanted to remind you that the data should consists of plasma concentrations vs time, individual pK parameters, dose, gender, age and weight.

Thanks Vasantha

Vasantha Kumar, M.S., Ph.D.
FDA/CBER/OBRR/DBA/RPMB
Room 485N/HFM-380
1401 Rockville Pike Rockville, MD 20852
Phone: 301-827-3524 Fax: 301-827-2857
E-Mail:  vasantha.kumar@fda.hhs.gov

 From: David.Desris@cslbehring.com [mailto:David.Desris@cslbehring.com] 
Sent: Friday, August 15, 2008 2:56 PM 
To: Kumar, Vasantha 
Subject: RE: STN.125317/0.CSL Behring. Human Fibrinogen Concentrate, Pasteurized. Riastap

Dear Vasantha

I have requested the PK data in an Excel format and will get back to you next week on how soon we can provide this to you. David

From: Kumar, Vasantha [mailto:Vasantha.kumar@fda.hhs.gov] 
Sent: Friday, August 15, 2008 2:07 PM 
To: Desris, David US/KOP; Hill, John US/KOP 
Subject: STN.125317/0.CSL Behring. Human Fibrinogen Concentrate, Pasteurized. Riastap
Importance: High

Hi David and John,

I had a request from the PK reviewer to request you to provide raw plasma concentration/time data in an Excel format. I would appreciate it very much if you could provide your response at the earliest.

Thanks Vasantha

 Vasantha Kumar, M.S., Ph.D.
FDA/CBER/OBRR/DBA/RPMB
Room 485N/HFM-380
1401 Rockville Pike Rockville, MD 20852
Phone: 301-827-3524 Fax: 301-827-2857
E-Mail:  vasantha.kumar@fda.hhs.gov

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