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Dendreon PLI - Preliminary Report - Provenge, February 25, 2010

(System Info - 126208 Finn Thomas 04/16/2010 13:20:38 TULL)

Dendreon PLI - Preliminary ReportFrom: Finn, Thomas
Sent: Thursday, February 25, 2010 10:41 AM
To: 'Smith, Liz'
Cc: Oh, Steven; Tull, Lori; Wang, Gang; Melhem, Randa
Subject: RE: Dendreon PLI - Preliminary Report

Hi Liz a few quick follow-up questions:

a.. When was the product disposition faxed to the infusion site?
b.. In response to our previous request you have implemented a process step time of -----(b)(4)---------- for packaging the product after formulation (Amendments 24 and 32). Please indicate how much of this step time was used for each of the lots generated during the PLI.
c.. Could you please indicate how long total ---------(b)(4)----------- processing took for each lot?

Thanks,

Tom

 

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From: Smith, Liz [mailto:lsmith@Dendreon.com]
Sent: Wednesday, February 17, 2010 7:06 PM
To: Wang, Gang; Melhem, Randa
Cc: Finn, Thomas; Oh, Steven; Tull, Lori
Subject: RE: Dendreon PLI - Preliminary Report

Darnit! Here you go!

 

********************************************
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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From: Wang, Gang [mailto:Gang.Wang@fda.hhs.gov]
Sent: Wednesday, February 17, 2010 4:00 PM
To: Smith, Liz; Melhem, Randa
Cc: Finn, Thomas; Oh, Steven; Tull, Lori
Subject: RE: Dendreon PLI - Preliminary Report

 

Liz, I didn?t see the attachment.

 

Gang


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From: Smith, Liz [mailto:lsmith@Dendreon.com]
Sent: Wednesday, February 17, 2010 6:58 PM
To: Melhem, Randa
Cc: Wang, Gang; Finn, Thomas; Oh, Steven; Tull, Lori
Subject: RE: Dendreon PLI - Preliminary Report

 

Hi Randa,

 

Please find attached the requested information. This information has been submitted as an amendment to the BLA (amendment 039) and this is a copy for your convenience.

 

Please let me know if you have any further questions.

 

Kind Regards,

 

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

*******************************************


--------------------------------------------------------------------------------

From: Melhem, Randa [mailto:Randa.Melhem@fda.hhs.gov]
Sent: Tuesday, February 16, 2010 8:57 AM
To: Smith, Liz
Cc: Wang, Gang; Finn, Thomas; Oh, Steven; Tull, Lori
Subject: Dendreon PLI - Preliminary Report

 

 

Hi Liz,

Thank you for the preliminary report for the lots processed during the inspection.
For each lot, please provide in a Table format the time for each of the following steps:

a.. Collection of APH at the Apheresis Site
b.. Receipt of APH at Dendreon, NJ
c.. Start of the manufacturing -b(4)- ? (b)(4)
d.. Start of incubation
e.. Start of manufacturing of Drug Product ? (b)(4)
f.. Filling of Drug Product into Sipuleucel-T Primary container
g.. Packaging of Drug Product in secondary shipping package
h.. Collection of package by courier
i.. Receipt of the Drug Product at the clinic
j.. Infusion of the Drug product into the patient

Thanks again,

Randa Melhem, Ph.D.
Consumer Safety Officer
FDA/CBER/OCBQ/DMPQ
Phone: 301-827-6999 Fax 301-827-3536

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