hapabapa Canada-based Milestone Pharmaceuticals (NASDAQ:MIST) announced Tuesday that the U.S. Food and Drug Administration (FDA) refused to accept its New Drug Application (NDA) for its lead candidate, etripamil. The company shares fell ~20% before the opening bell in reaction. Issuing a so-called Refusal to File (RTF) letter, the agency noted that the company had not provided adequate data for it to begin a review.

总部位于加拿大hapabapa的Milestone Pharmaceuticals（纳斯达克：MIST）周二宣布，美国食品和药物管理局（FDA）拒绝接受其主要候选药物etripamil的新药申请（NDA）。该公司股价在开盘前下跌了约20%。该机构发出了一封所谓的拒绝提交（RTF）信函，指出该公司没有提供足够的数据来开始审查。

The FDA has requested clarity on the timing of adverse events recorded in Phase 3 trials. In October, Milestone (MIST), headquartered in Montréal, Canada, submitted its NDA for etripamil nasal spray targeting paroxysmal supraventricular tachycardia, a cardiac disorder characterized by abnormal heart rhythm.

FDA要求明确3期试验中记录的不良事件发生的时间。10月，总部位于加拿大蒙特勒尔的Milestone（MIST）提交了其针对阵发性室上性心动过速（一种以心律异常为特征的心脏病）的etripamil鼻喷雾剂的NDA。

'We intend to work with the FDA to better understand the open issues and to agree on a path forward,' CEO Joseph Oliveto noted. The company is looking to meet with the regulator to seek further clarity regarding its decision. More on Milestone Pharmaceuticals Seeking Alpha’s Quant Rating on Milestone Pharmaceuticals Historical earnings data for Milestone Pharmaceuticals Financial information for Milestone Pharmaceuticals .

首席执行官约瑟夫·奥利维托（JosephOliveto）指出，我们打算与FDA合作，更好地了解悬而未决的问题，并就前进的道路达成一致。该公司正寻求与监管机构会面，以进一步明确其决定。更多关于Milestone Pharmaceuticals寻求Alpha对Milestone Pharmaceuticals的定量评级Milestone Pharmaceuticals的历史收益数据Milestone Pharmaceuticals的财务信息Milestone Pharmaceuticals的财务信息。