
Request GSK's Proposals, October 25, 2011 - MenHibrix

 
 
From: Staten, David 
Sent: Tuesday, October 25, 2011 1:49 PM
To: 'Jody Gould'; Temenak, Joseph; Prutzman, Kirk C
Cc: Sutkowski, Elizabeth M.
Subject: RE: STN BL/125363 - MenHibrix - update regarding response to Sept 21 CR Letter
Jody -  You can send Tina her requests via email but please follow up this and all other proposals as official amendments to the file.


From: Jody Gould [mailto:jody.a.gould@gsk.com] 
Sent: Friday, October 21, 2011 4:36 PM
To: Temenak, Joseph; Prutzman, Kirk C; Staten, David
Cc: Sutkowski, Elizabeth M.
Subject: RE: STN BL/125363 - MenHibrix - update regarding response to Sept 21 CR Letter
Importance: High
Dear Joe, David, Kirk,
Per my previous emails, GSK’s proposal regarding the serology Items from the CR letter is attached.   

The majority of the document focuses on how we plan to respond to Item 1; we have also briefly outlined the proposed responses to the other items.  We look forward to discussing this proposal with CBER representatives at your earliest convenience.

On a related topic, Tina Roecklein called me this week to request a couple of minor items. Please let her know I am preparing to submit these to the BLA by middle of next week.  I she would like to have them sooner via email, please advise. 

Feel free to call or email with any questions.

Thanks,

Jody

Jody Ann Gould, PhD
Senior Director
US Regulatory Affairs
jody.a.gould@gsk.com
610-787-3765 (phone)
--------(b)(6)----------
610-787-7063 (fax)


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From: Jody Gould 
Sent: Thursday, October 13, 2011 3:23 PM
To: 'Temenak, Joseph'
Cc: Prutzman, Kirk C; Staten, David; Sutkowski, Elizabeth M.
Subject: RE: STN BL/125363 - MenHibrix - update regarding response to Sept 21 CR Letter
Importance: High

Dear Joe,

The proposal for discussion regarding specific CMC items from the CR letter is attached.
I expect to send the serology document to you next week. 

Thanks again for you help,

Jody

From: Temenak, Joseph [mailto:Joseph.Temenak@fda.hhs.gov] 
Sent: Wednesday, October 12, 2011 10:24 AM
To: Jody Gould
Cc: Prutzman, Kirk C; Staten, David; Sutkowski, Elizabeth M.
Subject: RE: STN BL/125363 - MenHibrix - update regarding response to Sept 21 CR Letter

Jody,

Thank you for your email below.  We have forwarded the email to the review team for MenHibrix.  Once we receive the outlines/summaries you mention below (On or before Oct. 12 and 19), we'll forward them to the review team as well.  After we've had a chance to look over/discuss your responses, we'll communicate further.

Thank you,

Joe 


From: Jody Gould [mailto:jody.a.gould@gsk.com] 
Sent: Monday, October 10, 2011 7:11 PM
To: Temenak, Joseph
Cc: Prutzman, Kirk C; Staten, David
Subject: STN BL/125363 - MenHibrix - update regarding response to Sept 21 CR Letter
Importance: High
Dear Joe-
Following up to our conversation last week, I am providing an update regarding GSK’s plans to respond to the CR Letter.

CR Letter items for discussion
As we discussed, GSK has identified several items that we would like to discuss with CBER representatives as soon as possible.  These items are:  1, 4a and b, 8, 10d, 15, 19 and 21.

We currently plan to provide, via email, outlines of our proposed responses to these items to CBER grouped as follows.  
-          Item 1 – on or before October 19
-          Items 4a, 4b, 8, 10, 15, 19, 21 – on or before October 12

GSK proposes that 2 separate teleconferences be held (one for each topic/package).  We acknowledge that CBER will review the full responses to these items to determine their acceptability. Our goal for these discussions is assure that GSK understands these items/questions (clarification) so that we can be as responsive as possible to CBER’s requests.

As we would like to discuss these items with CBER as soon as possible, and GSK representatives will be available at CBER’s convenience.  We do kindly request that any teleconferences be scheduled before noon, if possible, so that our Belgian colleagues may participate during normal work hours.

CR Letter item for clarification only
Note that GSK previously requested clarification of Item 2.b.i via email on September 28.

Please contact me to arrange teleconferences or with any questions.

Thanks,

Jody

Jody Ann Gould, PhD
Senior Director
US Regulatory Affairs
jody.a.gould@gsk.com
610-787-3765 (phone)
610-787-7063 (fax)


Trade secret and/or confidential commercial information contained in this message (including any attachments) is exempt from public disclosure to the full extent provided under law. If you are not the intended recipient of this message, or if you are not responsible for delivering it to the intended recipient(s), do not use, disclose, reproduce, or distribute this message (including any attachments). If you have received this message in error, please erase all copies (including any attachments) and notify me immediately. Thank you.
