Zevra Therapeutics Receives Negative Opinion From EMA CHMP On Its Marketing Authorization Application For Arimoclomol For The Treatment Of Niemann-Pick Disease Type C
Under European regulatory procedures, the Company plans to request a re-examination of the CHMP opinion and submit a detailed explanation outlining the basis for the request."While the review did not result in the
A European medicine board said no to Zevra's drug for a rare disease, but the company plans to ask them to look at it again and explain why it should work. When companies get rejected by regulators, watch if their science was really strong enough or if something else needs fixing.
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