10-10-2008 Record of Telecon - Ixiaro

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: 10-OCT-2008                          Initiated by FDA? Yes
 Telephone Number:

Communication Categorie(s): Advice

Author: DARYLL MILLER

Telecon Summary: Discussion of responses to CR letter. Responses have been accepted by product reviewers including proposed -(b)(4)- assay and validation. Sponsor agreed to provide specifications for protamine sulphate.

FDA Participants:

Daryll Miller
 Richard Daemer
 Lew Markoff
 Li Yu
 Barry Falgout
 Destry Sillivan

Non-FDA Participants:

Thomas LINGELBACH, COO, Intercell AG
 David VENABLES; Site Director, Intercell Biomedical
 Christoph KLADE; Technology Development / Clinical Immunology
 Murray MCKAY, Quality Operations
 Fraser LESLIE; Quality and Regulatory Compliance
 Paul WILSON, Intercell USA

Trans-BLA Group: No

Related STNs: None

Related PMCs: None
