BUZZ-美国 FDA 驳回时差药申请,旺达跌停1月8日 - ** 制药商旺达制药VNDA.O股价盘前下跌12.65%,至7.46美元
** 该公司称已收到美国食品及药物管理局的一封信,拒绝批准 (link) 使用其睡眠药物 Hetlioz 治疗时差反应。
** FDA 指出试验使用的是模拟时差,而不是真实的空中旅行 - VNDA
** 公司表示不同意 FDA 的决定,并计划与该机构进一步谈判
** Hetlioz 已被批准用于治疗两种罕见的睡眠障碍
** 截至上次收盘,股价在过去一年中下跌了 ~3
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