November 9, 2017 / 6:50 AM / a month ago

BRIEF-Pharma Mar expects EMA not to approve its Aplidin for multiple myeloma treatment

Nov 9 (Reuters) - PHARMA MAR SA:

* SAID ON WEDNESDAY, EXPECTS AN OPINION RECOMMENDING AGAINST APPROVAL OF MARKETING AUTHORIZATION APPLICATION FOR APLIDIN FOR TREATMENT OF MULTIPLE MYELOMA FROM EUROPEAN MEDICINES AGENCY (EMA) BASED ON PRELIMINARY “TREND VOTE” FEEDBACK FROM AGENCY

* FORMAL WRITTEN DECISION FROM EMA‘S COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) IS EXPECTED FOLLOWING ITS DECEMBER 2017 MEETING (DEC 11 TO DEC 15)

* COMPANY DEEPLY SURPRISED ABOUT CHMP NEGATIVE TREND VOTE GIVEN RESULTS OF PHASE III TRIAL

* CHMP NEGATIVE TREND VOTE WAS VERBALLY COMMUNICATED TO COMPANY BY EMA

Source text for Eikon:

Further company coverage: (Gdynia Newsroom)

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