IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human ...( IRVINE Calif. Sept. 26 /- IDM Pha...),Health

IRVINE, Calif., Sept. 26 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI) today announced that it met with representatives of the Committee for Medicinal Products for Human Use (CHMP) and Secretariat of the European Medicines Agency (EMEA) on September 25th, following the CHMP's September meeting where CHMP considered the Company's Marketing Authorization Application (MAA) for mifamurtide (L-MTP-PE) for the treatment of patients with non-metastatic, resectable osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults.

Based on discussions at that meeting, the Company has been invited to present to the CHMP Scientific Advisory Group on Oncology (SAG-O) and to the CHMP to review and address the remaining open issues in its MAA for L-MTP-PE. These meetings are scheduled to take place in November. The SAG-O is regularly convened at the request of the CHMP to provide independent advice on scientific/technical matters relating to oncology products under evaluation by the CHMP, or on any other scientific issue relevant to the work of the CHMP that relates to this area. The Company will provide SAG-O and CHMP information to address the remaining open issues in advance of these meetings.

"The European review of L-MTP-PE continues to progress," said Timothy P. Walbert, president and chief executive officer, IDM Pharma. "We are pleased to report that, in response to the comprehensive information we submitted in advance of the September CHMP meeting, the CHMP has determined that the Children's Oncology Group's (COG) Phase 3 trial is compliant with Good Clinical Practices (GCP) and that the database from this pivotal study can be reliably used in the evaluation process of the MAA. We also r
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