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BRIEF-Santhera: negative opinion from the CHMP for Raxone in DMD
September 15, 2017 / 5:11 AM / 2 months ago

BRIEF-Santhera: negative opinion from the CHMP for Raxone in DMD

Sept 15 (Reuters) - SANTHERA PHARMACEUTICALS HOLDING AG:

* SANTHERA RECEIVES NEGATIVE OPINION FROM THE CHMP FOR ITS MARKETING AUTHORIZATION APPLICATION FOR RAXONE® IN DMD AND INTENDS TO APPEAL THIS OPINION

* ‍WILL SEEK A RE-EXAMINATION BY CHMP​

* ‍CHMP EXPRESSED UNCERTAINTIES WHETHER PHASE III DELOS TRIAL PROVIDES SUFFICIENT EVIDENCE OF EFFICACY​ Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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