中裕重大訊息 - 股票
By Suhail Hany
at 2017-08-19T23:47
at 2017-08-19T23:47
Table of Contents
1.原文連結：
公開資訊觀測站
https://goo.gl/4zi5nD
2.原文內容：
主旨：
公告美國FDA有關TMB-355藥證審查中期會議結果及未來預計相關會議時程
1.事實發生日:106/08/19
2.公司名稱:中裕新藥
3.與公司關係(請輸入本公司或子公司):本公司
4.相互持股比例:不適用
5.發生緣由:
本公司於美國時間8月18日與美國FDA舉行 TMB-355 BLA審查的中期會議(Post-Midcycle
Meeting)。FDA針對目前審查的結果及需要補件的部分提出說明。會議順利，無需針對藥
物安全性的風險做評估管理。FDA並告知BLA審查的後期會議(Late-Cycle Meeting)已訂於
10月31日。另外，FDA也再次通知不需要召開專家諮詢會議，並且將於10月3日以前通知公
司有關於TMB-355藥品標籤內容的細節。
3.心得/評論：
查廠看來已通過，只差年底藥證到手了。
台灣第一個國際大藥即將出現。
--
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