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BRIEF-Ab Science: CHMP adoptes negative opinion for masitinib in indolent systemic mastocytosis
May 17, 2017 / 5:23 PM / 6 months ago

BRIEF-Ab Science: CHMP adoptes negative opinion for masitinib in indolent systemic mastocytosis

May 17 (Reuters) - AB SCIENCE SA:

* REG-AB SCIENCE ANNOUNCES THAT CHMP HAS ADOPTED A NEGATIVE OPINION FOR MASITINIB IN INDOLENT SYSTEMIC MASTOCYTOSIS, PRIMARILY DUE TO GCP INSPECTION FINDINGS

* AB SCIENCE WILL ASK FOR A RE-EXAMINATION WITH OPINION OF A SCIENTIFIC ADVISORY GROUP (SAG) TO EVALUATE BENEFIT-RISK BALANCE

* HAS IMPLEMENTED THE CORRECTIVE ACTIONS TO ADDRESS THE GCP FINDINGS

* AB SCIENCE WILL ASK FOR A RE-EXAMINATION

* RE-EXAMINATION SHOULD LEAD THE CHMP TO DELIVER A SECOND OPINION IN Q4 2017 Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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