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Sunday, 01/03/2021 7:42:34 AM

Sunday, January 03, 2021 7:42:34 AM

Post# of 403039
"Fulfill ethical obligations to participants and the research community"

That is the #1 reason listed as the purpose of registering your study

https://www.clinicaltrials.gov/ct2/manage-recs/background


Can I register a study after it has started, has closed to recruitment, or has been completed?
Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant
https://www.clinicaltrials.gov/ct2/manage-recs/faq#registerIND


Is Leo too busy to register the now approved trial? I have heard rumors from significant shareholders they introduced Leo to another RBL that could have sped up the process by 2 months however Leo burned that bridge. Another RBL. Not some independent lab, but a US Goverment RBL just like GMU. Any hoo, at least we are at the P2 starting line. Let's see how it unfolds

the above is all IMHO (consider this my safe harbor statement)

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