BiMo GSK Request Email- Cervarix, May 22, 2007

Gemignani, Helen S



From: Sharon.W.Shapowal@gsk.com
 Sent: Tuesday, May 22, 2007 10:01 AM
 To: Gemignani, Helen S
 Subject: Re: May 21 Request
 Attachments: May 21 BiMo request.pdf

Page 1 of 1
 2/27/2009
 Dear Helen: I have discussed with GSK biometrics this request. The all-inclusive listing could be produced, but does not exist at this date. We wanted to assure that the FDA BiMo group has considered the information in section 6.2.3 of the report before creating the listing. It may be that the level of detail is not sufficient for their purposes, but it may be. I'm simply checking before we do the work of creating the table. Our biometrics team would, essentially, expand on the information in this section. Is that
 correct?
 Thanks and kind regards,
 Sharon
 S.W.Shapowal
 Director, Adult Vaccines
 (610) 787-3763
 (internal: 8-275-3763)

 May 21 BiMo Request for Information.
 <<May 21 BiMo request.pdf>>


 Helen Sullivan Gemignani
 Regulatory Project Manager
 FDA/CBER/OVRR
 Division of Vaccines and Related Products Applications/Viral Vaccine Branch
 (301) 827-3070
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