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Request for Clarification Email, March 15, 2011 - Laviv

From: Jeanne Novak [jnovak@cbrintl.com]
Sent: Tuesday, March 15, 2011 6:14 PM
To: Tull, Lori
Cc: Dana Weinberger; Jeanne Novak
Subject: RE: Request for clarification

Importance: High

Attachments: emfalert.txt

Dear Lori,

Dana and the team looked into this issue and determined that the table you sent over seems to be misaligned between the subject ID number and the treatment assignment columns . We can send you a fax or pdf showing how these should be aligned (one row off). In short, -(b)(6)- did receive azficel-T in IT-R-006.

Let us know if you would like to have us send the annotated document back to you.

Jeanne and Dana

 

Jeanne M. Novak, Ph.D.

CEO and Principal Consultant

CBR International Corp.®

720-746-1190

720-746-1192 (Fax)

www.cbrintl.com

 

This electronic transmission (including any and all attachments) is intended solely for the use of the individual or entity to whom it is addressed and may contain information that is privileged and/or confidential. If you are not the intended recipient of this electronic transmission, you are hereby notified that any disclosure, copying or distribution, or the taking of any action in reliance upon the contents of this electronic transmission, is strictly prohibited, and you are further requested to purge this electronic transmission and all copies thereof from your computer system.

 

From: Tull, Lori [mailto:Lori.Tull@fda.hhs.gov]
Sent: Monday, March 14, 2011 8:27 AM
To: Jeanne Novak; Dana Weinberger
Subject: Request for clarification

 

Hi Jeanne and Dana,

 

Would you please help us clarify the following:

Subject -(b)(6)- received Placebo (see Table below in red ink) during study 006 according the assignment chart below; however, you stated that the subject received three treatments of azficel-t instead of placebo in study 006 in Amendment 35 (see paragraph on page 6 of amendment 35 below in red ink).

"On 25 June 2010 the subject received 0.2 mL azficel-T intradermally in his right arm

and 0.2 mL placebo (saline) in his left arm as part of the Fibrocell IT-H-001 clinical

study. (Note: Previously, subject had received three treatments, five weeks apart of

1.15 mL azficel-T to his face for the treatment of nasolabial fold wrinkles in 2007 as

part of the Fibrocell IT-R-006 clinical study)".

 

ASSIGNMENT PATIENT IDENTIFICATION NUMBER LOCATION

(b)(6)
--------(b)(6)--------
Placebo

(b)(6)
--------(b)(6)--------
IT

(b)(6)
--------(b)(6)--------
Placebo

(b)(6)
--------(b)(6)--------
Placebo

(b)(6)
--------(b)(6)--------
IT

(b)(6)
--------(b)(6)--------
IT

(b)(6)
--------(b)(6)--------
IT

(b)(6)
--------(b)(6)--------
Placebo

(b)(6)
--------(b)(6)--------
Placebo

(b)(6)
--------(b)(6)--------
IT

(b)(6)
--------(b)(6)--------
Placebo

(b)(6)
--------(b)(6)--------
N/A

(b)(6)
--------(b)(6)--------
N/A

(b)(6)
--------(b)(6)--------
N/A

(b)(6)
--------(b)(6)--------
N/A

(b)(6)
--------(b)(6)--------
N/A

(b)(6)
--------(b)(6)--------
N/A

(b)(6)
--------(b)(6)--------
N/A

(b)(6)
--------(b)(6)--------
N/A

(b)(6)
--------(b)(6)--------
N/A

(b)(6)
--------(b)(6)--------
N/A

(b)(6)
--------(b)(6)--------
N/A
 

 

IT-R-006
6600
Placebo
(b)(6)
--------(b)(6)--------
 

Placebo
(b)(6)
--------(b)(6)--------

Placebo
(b)(6)
--------(b)(6)--------

Placebo
(b)(6)
--------(b)(6)--------

IT
(b)(6)
--------(b)(6)--------

IT
(b)(6)
--------(b)(6)--------

IT
(b)(6)
--------(b)(6)--------

Placebo
(b)(6)
--------(b)(6)--------

Placebo
(b)(6)
--------(b)(6)--------

IT
(b)(6)
--------(b)(6)--------

IT
(b)(6)
--------(b)(6)--------

IT
(b)(6)
--------(b)(6)--------

Placebo
(b)(6)
--------(b)(6)--------
 

 

Lori A. Tull, RAC

Regulatory Project Manager

Office of Cellular, Tissue, and Gene Therapies

Center for Biologics Evaluation and Research

(301) 827-5359

 

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