Orphazyme Wants More Time To Deal With Late-Stage Issues For Arimoclomol In EU
Other Sponsors Also Ask For A Longer Pause To CHMP’s Review Clock
Following Orphazyme’s disappointment in the US regarding its investigational drug for an ultrarare disease, the company has said it will need more time to address outstanding issues raised by EU reviewers about the same medicine.
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Following a week of "insane trading" which saw the Danish stock soar based on social media chatter, US regulators have surprised the firm and investors by issuing a complete response letter for arimoclomol for Niemann-Pick disease type C.