Telecon - Information Request, May 4, 2009 - Menveo

System Info - 110659  VALENTI, ELIZABETH   12-Nov-2009 14:47:38  VALENTI

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125300/0    Office: OVRR  

Product:
Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Applicant:                                                                       
Novartis Vaccines and Diagnostics, Inc.          

Telecon Date/Time:  04-MAY-2009 04:43 PM              Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  CARA FIORE

Telecon Summary:
requested again 24 month stability data (both requested via email)

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
From:                     Fiore, Cara 
Sent:                      Monday, May 04, 2009 4:43 PM
To:                          'christopher.webster@novartis.com'
Cc:                          Valenti, Elizabeth
Subject:                Stability data

Hi Chris,

Please let me know if Novartis is planning on submitting 24 month stability data for Menveo.  We would like to see it soon, if so.

Thanks,
cara