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Draft Agenda For Tomorrow's T'con - Provenge, November 5, 2009

From:              Bross, Peter F (CBER)
To:                 "Smith, Liz"; Tull, Lori;
cc:                 George, Bindu;
Subject:          Draft Agenda for tomorrow"s T"con
Date:              Thursday, November 05, 2009 6:40:04 PM
Attachments:    Dendreon Questions11-6-09 (4).doc
 


 Liz:

Sorry I got these out too late for Lori to send to you today. Due to the time zone I thought I would send you an agenda tonight in case it would be helpful for planning. In the future I will try to convey all agendas and other materials through Lori.

We do not expect you to work late tonight and try to get responses to these questions by tomorrow. If you can direct us to the BLA submission for answers that would be helpful otherwise we will plan to clarify any of these questions which you don't understand and schedule a followup T'con to discuss your responses.

Thanks,

Peter F. Bross, MD
Medical Review Officer
Office of Cellular, Tissue, and Gene Therapy, HFM-755
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852
Phone 301 827 5142
Fax 301 827 979
Peter.Bross@fda.hhs.gov

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From: Smith, Liz [mailto:lsmith@Dendreon.com]
Sent: Friday, October 30, 2009 5:58 PM
To: Bross, Peter F (CBER); Tull, Lori
Subject: Agenda for Friday

Hi Peter and Lori,

We are confirmed for a telecom on Friday 11/6 at 2 pm EST. The conference number is 888-924-9240, code (b)(2).

We will have clinical, regulatory and biometrics participating (including Brent Blumenstein). Do you have specific agenda items or questions that you know you want to cover?

Talk to you on Friday. Have a nice weekend.

Best,

Liz

 


********************************************
Elizabeth C. Smith
Vice President of Regulatory Affairs
Dendreon Corporation
3005 First Ave
Seattle, WA 98121
t: 206.829.1556/ f: 206.219.1004/ m. 206.719.4366
esmith@dendreon.com
*******************************************

 


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