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Information Request Email, February 16, 2011 - Anascorp


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

Hi Jennifer

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. 

Debbie

Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR
Voice: 301-827-6157
debbie.cordaro@fda.hhs.gov

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender by e-mail or phone.



 

From: Jennifer Spinella [mailto:jspinella@raretx.com]
Sent: Monday, February 14, 2011 2:33 PM
To: Cordaro, Debbie
Cc: Linda Martinez; Milton Ellis
Subject: Information Request for STN: 125335/0


Hi Debbie,
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.
Thanks,
Jennifer

Jennifer Spinella, MT(ASCP), RAC
Vice President, Regulatory Affairs and Quality Assurance
Rare Disease Therapeutics, Inc.
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Phone:  858-586-0751
Fax:  858-586-1108
Cell:  619-905-0489
Email:  jspinella@raretx.com