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  • 16 November 2012
    Santhera expects CHMP opinion on its MAA for RaxoneŽ early 2013

    Santhera Pharmaceuticals (SIX: SANN)announced today that the opinion of the Committee for Medicinal Products for Human Use (CHMP) on its Marketing Authorization Application (MAA) for Raxone® in the treatment of Leber's Hereditary Optic Neuropathy (LHON) is expected to be obtained in early 2013.

    "We expected to obtain the CHMP's decision on our MAA for Raxone in LHON by the end of this year," said Thomas Meier, Santhera's CEO. "Further interaction with the CHMP and submission of additional information has resulted in a revised timeline for the procedure. We now expect that the CHMP will render an opinion on our application in early 2013."