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BRIEF-Selvita: FDA suspends clinical trial of SEL24 after patient death
October 9, 2017 / 6:34 AM / in 10 days

BRIEF-Selvita: FDA suspends clinical trial of SEL24 after patient death

Oct 9 (Reuters) - SELVITA SA:

* SAID ON SATURDAY THAT FOOD AND DRUG ADMINISTRATION (FDA) ORDERED SUSPENSION OF CLINICAL TRIAL OF SEL24

* FDA ISSUED DECISION AFTER THE DEATH OF PATIENT FOLLOWING A STROKE THAT HAD PREVIOUSLY OCCURRED AND WAS REPORTED AS SUSPECTED SERIOUS UNEXPECTED ADVERSE REACTION

* COMPANY INFORMED ABOUT ADMITTING ITS PRODUCT SEL24 TO CLINICAL TRIALS BY FDA IN AUGUST

* COMPANY TO WORK CLOSELY WITH FDA TO RESUME THE STUDY AS SOON AS POSSIBLE BY PROVIDING ADDITIONAL DATA AND INTRODUCING AMENDMENTS IN TRIAL PROTOCOL

Source text for Eikon:

Further company coverage: (Gdynia Newsroom)

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