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RE: Statistical Consult - Provenge, October 15, 2009

From:                     Gupta, Ghanshyam
To:                         Dapolito, Gail;
cc:                         Ball, Robert; Zhen, Boguang (CBER); Hsu, Henry; Gupta, Ghanshyam;
Subject:                  RE: Statistical Consult
Date:                      Thursday, October 15, 2009 3:13:19 PM
Attachments:            D9902B summary and Question.pdf
 

 

Thanks Gail:
The document is enclosed. It is only two page document.
I will send an email to inform him about the FedEx. I will also inform him that we will be contacting him for a telecon sometime next week to discuss the issue and to find out if he needs additional information.

Thanks for your support.

>Ghanshyam Gupta
>Chief, Therapeutics Evaluation Branch
>Division of Biostatistics, FDA/CBER/OBE
>Phone: 301-827-6024
>Fax: 301-827-5218

-----Original Message-----
From: Dapolito, Gail
Sent: Thursday, October 15, 2009 2:53 PM
To: Gupta, Ghanshyam
Cc: Ball, Robert; Zhen, Boguang (CBER); Hsu, Henry
Subject: RE:Statistical Consult

2 ways
Call him first and tell him a confidential fax is coming, so you can be waiting at the fax machine or
Send it to him by FedEx - it will arrive tomorrow.

If you need help sending it by FedEx and are comfortable sending me the electronic document, I will print out and put it in FedEx this afternoon.

Gail

-----Original Message-----

From: Gupta, Ghanshyam
Sent: Thursday, October 15, 2009 2:50 PM
To: Dapolito, Gail
Cc: Ball, Robert; Zhen, Boguang (CBER); Hsu, Henry
Subject: RE: Statistical Consult

Hi Gail:

When I started to draft this letter to Prof D'Agostino, I realized that we plan to send an extremely sensitive proprietary information to him in an email. As we all very well know, an email sent to an unsecured destination can be easily read by someone who is not the right owner of the email. This can lead to serious consequences.

How do you suggest we send the material to Prof. D'Agostino?

 

>Ghanshyam Gupta
>Chief, Therapeutics Evaluation Branc
>Division of Biostatistics, FDA/CBER/OBE
>Phone: 301-827-6024
>Fax: 301-827-5218

-----Original Message-----
From: Dapolito, Gail
Sent: Thursday, October 15, 2009 2:09 PM
To: Gupta, Ghanshyam
Subject: RE: Statistical Consult

That is good because I told him we would get him something this week.

-----Original Message-----
From: Gupta, Ghanshyam
Sent: Thursday, October 15, 2009 2:08 PM
To: Dapolito, Gail
Subject: RE: Statistical Consult

Thank you.

We plan to send him an email today.

>Ghanshyam Gupta
>Chief, Therapeutics Evaluation Branch
>Division of Biostatistics, FDA/CBER/OBE
>Phone: 301-827-6024
>Fax: 301-827-5218

-----Original Message-----
From: Dapolito, Gail
Sent: Thursday, October 15, 2009 1:58 PM
To: Gupta, Ghanshyam
Subject: FW: Statistical Consult

Dr. D'Agostino's contact information:

Ralph B. D'Agostino, Sr., Chair
Mathematics and Statistics Department
Professor of Mathematics/Statistics and Public Health
Executive Director MA/PhD Program in Biostatistics
Director, Statistics and Consulting Unit
Director, Framingham Study: Statistics/Data Management
Statistical Consultant, New England Journal of Medicin
Editor, Statistics in Medicine
Editor, Encyclopedia of Clinical Trials
Boston University
111 Cummington Street
Boston, MA 02215
tel (617) 353 2767
fax (617) 353 4767
email ralph@bu.edu

Gail