System Info - 113318 SMITH, MICHAEL J 09-Dec-2009 16:11:10 SMITHM
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 16-SEP-2009 07:59 AM Initiated by FDA? Yes
Author: JULIENNE VAILLANCOURT
RE: Email from Jack Love at Wyeth to Julie Vaillancourt regarding safety study comments.
FDA Participants: Julie Vaillancourt
Non-FDA Participants: Jack Love, Carmel Devlin and Elizabeth Edwards
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Love Jack [LOVEJ@wyeth.com]
Sent: Wednesday, September 16, 2009 7:59 AM
To: Vaillancourt, Julienne
Cc: Devlin Carmel; Edwards Elizabeth
Subject: Safety Study comments
Wyeth met internally yesterday to review CBER's comments on the safety study. They plan to meet with Kaiser tomorrow to find out if they are in agreement and can implement these requests. The Wyeth team has two questions shown below that they were not completely certain as to what was being requested and are asking for clarification from CBER. The Wyeth interpretation is shown next to the CBER comment. Is there anyway you can talk this over with Marthe and get back to me today, so that the meeting with Kaiser tomorrow can address these requests appropriately?
Item 1(d), CBER notes: "Please submit two types of tabulations: one with grouped events/ICD-9 codes..." The wyeth team understands these "grouped events" to refer to the pre-specified events previously identified by CBER.
Item 1(d), 1st bullet CBER notes: "For other doses, tabulations need not include events that occurred in the pre-vaccination control window." Wyeth interprets this to mean that the pre-vaccine window will be required for the FIRST dose only; the pre-vaccine window will NOT be utilized in all subsequent doses.
End of telecon