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4 个月前
BRIEF-Repros Therapeutics meets with FDA to discuss Proellex in treatment of uterine fibroids
2017年4月10日 / 下午2点21分 / 4 个月前

BRIEF-Repros Therapeutics meets with FDA to discuss Proellex in treatment of uterine fibroids

April 10 (Reuters) - Repros Therapeutics Inc :

* Company holds meeting with FDA to discuss oral Proellex® in the treatment of uterine fibroids

* Before meeting, was notified meeting would be Type C/guidance meeting, rather than Type B/end of Phase 2 meeting as previously expected

* Company intends to announce further information following receipt of additional guidance from FDA on oral Proellex

* Company expects to submit additional information and a proposed clinical protocol within a month on oral Proellex

* FDA confirmed Proellex to continue on current partial clinical hold

* Proellex to continue on partial clinical hold while FDA consult's with its liver experts regarding previously disclosed effects on liver

* FDA agreed to accept additional information from co, its panel of liver experts for consideration by FDA's internal advisory liver team Source text for Eikon: Further company coverage:

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