Information Request for STN: 125335/0From: Cordaro, Debbie
Sent: Wednesday, February 16, 2011 4:53 PM
To: 'jennifer Spinella'
Subject: FW: Information Request for STN: 125335/0
The biostatistician has noted that we need the data sets to verify their reports.
Please submit the data sets you used in preparing the integrated summary of safety report so that we can verify the results in the report.
Regulatory Project Manager
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From: Jennifer Spinella [mailto:firstname.lastname@example.org]
Sent: Monday, February 14, 2011 2:33 PM
To: Cordaro, Debbie
Cc: Linda Martinez; Milton Ellis
Subject: Information Request for STN: 125335/0
Although I'm traveling I am working to formally respond to the information request for STN: 125335/0. We will provide the path for the xpt files. I have a question on the request for the ISS. This is a stand alone document. All information is included in the document, there are no appendices. Is there something in particular that the reviewer is missing? All tables and listings are included. Please clarify.
Jennifer Spinella, MT(ASCP), RAC
Vice President, Regulatory Affairs and Quality Assurance
Rare Disease Therapeutics, Inc.