The Company will continue working with the cooperative groups and investigative sites involved in the study to collect vital status (information on whether the subjects remain alive or have died) on patients who participated in the Phase 3 clinical trial and for whom complete data were not available at the time of filing of the NDA in October 2006. When the additional follow up data have been collected, the Company will analyze the data and expects to submit an amendment to the NDA to the FDA by the first quarter of 2008. In addition to collecting supplemental Phase 3 data, the Company will address the other points raised in the FDA action letter.
"While we believe the evidence demonstrating the overall survival benefit of L-MTP-PE exists, we commend IDM Pharma for their continued investment in and commitment to working with investigators to collect the most recent data available," said Matthew Alsante, executive director, Sarcoma Foundation of America. "As the survival in children with osteosarcoma has not improved in the last twenty years, gaining approval of investigational agents with demonstrated improvement in survival is critical."
Conference Call Details
The Company will be holding a conference call on Monday, August 27, 2007 at 4:30 p.m. ET. A webcast of the call will be accessible through the Company's website at http://www.idm-pharma.com. A replay of the call will be available on the website for 30 days.
U.S. Dial-In: (800) 289-0529
International Dial-In: 913-981-5523
Passcode (both U.S. and International): 4467870
About the mifamurtide (L-MTP-PE) NDA
The L-MTP-PE NDA includes efficacy and safety data from 678 patients
with non-metastatic resectable osteosarcoma, 332 of whom received L-MTP-PE,
and from 115 pati
|SOURCE IDM Pharma, Inc.|
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