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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Submission Review Email, September 27, 2012 - HPC, Cord Blood BLA 125432

From: Lin, Stan
To: jaevans@lifesouth.org
Cc: Jarvis, Candace;  Borigini, Mark
Subject: Cord Blood BLA 125432
Date: Thursday, September 27, 2012 1:01:12 PM


Hi Ms Evans,

I'm a statistical review at the FDA. I'm now working on the BLA12543 submission. It appears the submission consists of two electronic discs of data in the form of Microsoft Excel files. In working with the files (2011 and 2012) I note that the column headings of the data sheets within the files are not defined. Therefore, it limits our ability to work with the data sheets to produce summary tables. I would think that when these files were created, the column headings must have been defined. Would you please provide us with a definition file of these column headings, for each of the Excel sheets (e.g., Baseline, Infusion, ...) within the datasets (CIBMTR_Outcomes_data  ... 2011 and 2012 Excel files)? That would help us to create summary tables for our review of the submission.

Thank you in advance.

Stan Lin