GNI Group (2160) · RiskMitigated
Request for Additional Toxicity Testing in the U.S. IND for F351
First written in FY2016-Q2. 1 of 2 entries say "Materialised", first in FY2016-Q2. Latest entry: FY2017-Q3.
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F351 U.S. IND Additional Toxicity Study ResponseA theme 1 companies write about · 3 as a headwind · 1 as a tailwind
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- FY2017-Q3MitigatedAnnual report
「その後、2017年９月29日には、FDAより、肝線維症治療薬としての第１相臨床試験開始の承認を取得いたしました。」
FDAから要請された追加毒性試験・資料への対応が完了し、F351の米国第1相試験開始承認に至った。 - FY2016-Q2MaterialisedAnnual report
「The FDA requested toxicity test results covering at least 8 days and conducted under U.S. GLP standards.」
The FDA requested toxicity test results covering at least 8 days under U.S. GLP standards, requiring additional work on the U.S. IND application.