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Vaccines

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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