励晶太平洋(00575.HK)预计对Fortacin™第二阶段验证研究2019年年底前完成
格隆汇7月18日丨励晶太平洋(00575.HK)公告，内容有关与Yooya订立无法律约束力指示性要约，该要约内容有关公司可能收购Yooya，而该代价将以发行新股份方式支付。董事局谨通知股东，由于所有相关订约方无法就收购事项主要条款达成协议，有关上述可能收购事项讨论现已终止，于2019年7月17日生效。
重要的是于与Yooya讨论时，公司管理层获得一个更令人兴奋、具体及合适的机会以进军中国大麻行业，特别关注大麻二酚(CBD)注入式产品，该等产品在中国将需要大麻种植牌照以及加工及推出大麻加工设施牌照。董事局相信，此潜在收购事项在创造长期价值方面将对股东非常有利，且对股东摊薄影响较Yooya交易事项为低。
董事局亦欣然报告，针对美国食品及药品监督管理局审批程序而在美国对Fortacin™所进行第二阶段验证研究现时估计于2019年年底前完成。
假设试验足以令美国食品及药品监督管理局相信早泄烦恼评价调查问卷为支持标签声明的适当措施，关键的第三阶段工作可于2020年第一季度展开，而考虑到于2021年的处方药使用者费用法日期，可能于2020年下半年提交新药申请。该等日期乃接获的最近期指引并修正了公司于其公布、年度及中期报告及投资者简报中对美国食品及药品监督管理局审批流程的所有过往估计。
此外，董事局欣然报告，万邦医药(上海复星医药全资控股公司)已知会公司，其正针对2019年十月进行的临床试验审批(CTA)提交试验性新药(IND)申请，以于中国开展临床试验。试验性新药审查预计需时约60个工作日。假设可按照该时间表提交试验性新药，则最早可在2020年1月获得临床试验审批。根据与万邦医药签署并于2018年12月3日所公布许可协议的条款，于获得中国监管批准对一款许可产品开展人类临床试验后，万邦医药应向集团支付400万美元。
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