Postmarketing Safety Data - Cervarix, October 9, 2007

Gemignani, Helen S
 From: Sullivan, Helen M
 Sent: Tuesday, October 09, 2007 2:24 PM
 To: 'Sharon.W.Shapowal@gsk.com'
 Cc: 'Matt.Whitman@gsk.com'
 Subject: RE: clarification
 Sharon,
 Your proposals and responses are acceptable to CBER.
 Helen
 From: Sharon.W.Shapowal@gsk.com [mailto:Sharon.W.Shapowal@gsk.com]
 Sent: Friday, October 05, 2007 6:22 PM
 To: Sullivan, Helen M
 Cc: Matt.Whitman@gsk.com
 Subject: clarification
 STN 125259/0
 Dear Helen:
 My team has asked for clarification regarding the FAX of October 2, 2007. I'm attaching a clarifying note back to your
 team. Please let us know if our interpretation and/or proposal is acceptable.
 Thanks and regards,
 Sharon
 S.W.Shapowal
 Director, Adult Vaccines
 (610) 787-3763
 (internal: 8-275-3763)
 "EMF <fda.hhs.gov>" made the following annotations.
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