• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

RE: Production Schedule Proposal - Provenge, January 7, 2010

(System Info - 126206 Finn Thomas 04/16/2010 13:15:09 TULL)

From: Finn, Thomas
Sent: Thursday, January 07, 2010 2:21 PM
To: 'Smith, Liz'; Spooner, Connie
Cc: Wang, Gang; Tull, Lori
Subject: RE: Production Schedule Proposal

Hi Liz,

The figure you provided was very informative. Would it be possible for someone in your group to generate a similar simple figure describing a "typical" manufacturing day once the facility is operating at full (b)(4) workstation capacity? It would be nice to see an example of what a busy day (b)(4) would look like and what a less busy manufacturing day (b)(4) would look like and the kind of activities that are done with each shift. A picture is worth a thousand words...

I know actual manufacturing would depend on many, many variables, but a ballpark idea would suffice. Assume market demand is enormous.

Let me know if you think this is possible,

Thanks,

Tom

--------------------------------------------------------------------------------
From: Smith, Liz [mailto:lsmith@Dendreon.com]
Sent: Tuesday, January 05, 2010 3:17 PM
To: Tull, Lori
Cc: Wang, Gang; Finn, Thomas; Spooner, Connie
Subject: Production Schedule Proposal

Hi Lori,

Based on Gang and Tom?s request for the number of processes to be performed during the inspection, we have proposed the attached production schedule. Would you please let us know if the proposed schedule is acceptable for the inspection? We believe this meets the request for at least ---(b)(4)------ processes ((b)(4) per module) and also has some overlap of ----(b)(4)------ processing.

Thanks very much!

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

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

--------------------------------------------------------------------------------
This email message including any attachments is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply email and destroy all copies of the original message. If you are the intended recipient, please be advised that the content of this message is subject to access, review and disclosure by the sender's Email System Administrator.