Information Request for STN: 125335/0From: Jennifer Spinella [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.