About IDM Pharma
IDM Pharma is focused on the development of innovative cancer products that either destroy cancer cells by activating the immune system or prevent tumor recurrence by triggering a specific adaptive immune response. IDM Pharma is dedicated to maximizing the full therapeutic and commercial potential of each of its innovative products to address the needs of patients and the physicians who treat these patients.
For more information about the company and its products, visit http://www.idm-pharma.com.
This press release includes forward-looking statements that reflect
management's current views of future events including statements regarding
the pathway to a potential positive opinion from the CHMP based on the
CHMP's non-binding opinion regarding the clinical benefit in survival of
L-MTP-PE, the Company's plans to address the remaining questions with
respect to the MAA during the time extension or clock-stop granted by the
CHMP, and the expected timing of a final opinion from the CHMP and of a
final regulatory decision regarding the MAA in the European Union, as well
as the Company's plans to collect, analyze and submit additional Phase 3
data in an amended NDA for L-MTP-PE and to respond to other matters raised
by the FDA and timing for preparation of the NDA amendment. Actual results
may differ materially from the forward-looking statements due to a number
of important factors, including, but not limited to, whether the Company
will be able to provide clarification that provides assurance regarding the
quality of the existing data and to respond to the remaining issues with
regard to the MAA, including verification of data quality and chemistry,
manufacturing and controls (CMC) items, in a satisfactory manner during the
extension provided by the CHMP, whether the final opinion of the CHMP will
|SOURCE IDM Pharma, Inc.|
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