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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request, November 19, 2012 - HPC, Cord Blood BLA 125432


From:                      Borigini, Mark
To:                           "JAEvans@lifesouth.org"
Cc:              Lin, Stan;  Jarvis, Candace
Subject:     Information Request
Date:                       Monday, November 19, 2012 2:45:20 PM
Ms. Evans--
We were reviewing the dataset you submitted, and note that the "Product" sheet includes separate columns for "Infused Nucleated Cell Count" and "Total Infused Nucleated Cell Count."  What is the difference between these two?  We note that sometimes the values for these two are the same for a given patient; but there are also instances where the Total Infused Nucelated Cell Count is significantly higher than the Infused Nucleated Cell Count for the same patient.  (It appears you have calculated Post Thaw Cell Dose on the Infused Nucleated Cell Count.)
Please respond by noontime tomorrow (November 20, 2012); it would be appreciated.
Mark Borigini
Medical Officer