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Question Regarding 483 Responses - Provenge, February 23, 2010

(System Info - 126945 TULL LORI 04/25/2010 13:03:10 TULL)

From: Wang, Gang
Sent: Wednesday, February 03, 2010 1:59 AM
To: 'Smith, Liz'; Finn, Thomas
Cc: Tull, Lori; Syin, Chiang
Subject: RE: Question regarding 483 responses

Hi Liz, please see my responses to your questions. Let me know if there?s anything unclear. Thanks.

Gang

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From: Smith, Liz [mailto:lsmith@Dendreon.com]
Sent: Tuesday, February 02, 2010 6:31 PM
To: Finn, Thomas; Wang, Gang
Cc: Tull, Lori
Subject: Question regarding 483 responses

Dear Tom and Gang,

We are planning to submit the responses to the 483s next week. Can you please advise us on the following?

1) Where (name and address) should the responses be submitted and how many copies are desired? [Wang, Gang] it should be send as an amendment to BLA indicating it is inspection related. E-submission is preferred. Please copy all inspectors.

2) Should we also plan on submitting the responses as an amendment to the BLA? [Wang, Gang] yes, see above.

3) Do you need the production history summary (i.e., lots produced during inspection, including in process, final product test results, EM) with the 483 responses, or can we provide once final sterility results are reviewed and investigation complete? This would all be available shortly after the 483 responses are submitted. [Wang, Gang] you could submit the information as a separate amendment to BLA indicating it is inspection related. Please include the all the information you mentioned plus all the final testing results. Include all the deviations occurred if there?s any. The timing of aphresis receiving at Dendreon and product receiving at the infusion sites should also be included. Please also include the investigational report for the incident happened to one of the lots manufacturing during the inspection.

We also plan to submit a CMC and Facility Update amendment as discussed with Tom under separate cover in the next 7-10 days. [Wang, Gang] I agree it should be submitted as an amendment to BLA.

Thanks for your help,

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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