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Vaccines, Blood & Biologics

1/16/2009 Telecon

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application Submission ID: 125280/0 Office: OVRR

Product:
Japanese Encephalitis Virus Vaccine Inactivated

Applicant:
Intercell AG

Telecon Date/Time: 16-JAN-2009      Initiated by FDA?     Yes
Telephone Number:

Communication Categorie(s): Advice

Author: DARYLL MILLER

Telecon Summary: Discussion of revisions to PI provided to Sponsor on January 16, 2008 as well as PMCs. CBER and Sponsor agreed on final wording of PI which will be sent to Sponsor later in the day for approval by Sponsor. Protocol timelines were discussed for PMCs and will be included in the approval letter.

FDA Participants:
Daryll Miller
Richard Daemer
Lew Markoff
Jeff Roberts
Rose Tiernan

Non-FDA Participants:
Paul Wilson
Katrin Dubischar-Kastner
Elisabeth Schuller
Shailesh Dewasthaly

Trans-BLA Group: No

Related STNs: None

Related PMCs: None


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