3/14/2008 Teleconference Summary - Ixiaro

Teleconference Summary

STN Number: 125280
STN Sponsor: Intercell
STN Title: Japanese Encephalitis Vaccine

To: File
From: Daryll Miller
Subject: Response to Deficiencies Identified Letter of March 3, 2008
Teleconference Date: March 14, 2008 Meeting Time: 11:00 AM
Memo Date: April 11, 2008 Revision Date:

Signature: Summary of Meeting

Paul Wilson called to discuss a couple of questions from our March 3, 2008 Deficiencies Identified letter.

Question 2 was regarding Study #304. We asked where the clinical study report for this study was located. He stated that the study was to test immunogenicity of a shorter dosing schedule for emergency trips to endemic areas. The safety data was included in the BLA submission but not the Clinical Study Report. He wanted to know if we wanted the entire report considering that the results were not clinically significant and they are not making any claim for short dosing schedules. Subsequently we responded that we did want to have the entire report.

Question 12 was regarding Phase 4 studies. He stated that Intercell was in active discussions with the DOD regarding these studies but that they did not have an answer as yet. He expected to have an answer by the end of March or the beginning of April.

The last question concerned an e-mail that he had received from Destry Sillivan concerning the facilities inspection in Livingston, Scotland. Destry told Paul that he would be unable to come for the inspection on the prearranged date and would need to postpone the inspection until June, possibly. Paul was concerned about the manufacturing schedule because they had already changed their schedule to accommodate the inspection. They had originally requested an inspection for early May and moved it forward to April. They wanted to have the inspection before they filled the final product but were concerned that the proposed inspection in June would delay the availability of the commercial product. Subsequently the inspection was rescheduled for May 7 to 15.
