RE: Research20 Feb 2022 12:58
An unblinded interim analysis was conducted to assess futility on the first 300 randomised patients and was conducted once all of these patients had completed the day 35 visit or had withdrawn from the study. The primary analyses for the two primary endpoints was conducted for the interim analysis and provided to an Independent Data Monitoring Committee
(IDMC)
The Investigator holds such information in confidence and shall not disclose the information to any third party except to the Investigator's employees and staff who have been made aware that the information is confidential and who are bound to treat it as such and to whom disclosure is necessary to evaluate that information. The Investigator shall not use such
information for any purpose other than determining mutual interest in performing the study and, if the parties decide to proceed with the study, for the purpose of conducting the study.
Ditto after 610 patients in Dec 2021 after D35.
The Investigator understands that the information developed from this clinical study will be used by the Sponsor in connection with the development of SNG001 and other drugs and diagnostics, and, therefore, may be disclosed as required to other Clinical Investigators, business partners and associates and government agencies. The Investigator also understands that, to allow for the use of the information derived from the clinical study, the Investigator
has the obligation to provide the Sponsor with complete test results and all data developed in
the study.
No publication or disclosure of study results will be permitted except under the terms and
conditions of a separate written agreement between the Sponsor and the Investigator and/or the
Investigator's institution
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