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Thursday, November 23, 2017 10:51:52 AM
There is nothing exceptional in the above history. Clinical trials are often delayed - recruitment rate gets overestimated, needed funding gets underestimated, FDA may call for additional safety information etc.
BTW: For some posters here: it BS that FDA is not involved in early phase clinical trials: one does not run clinical trial without consulting FDA on trial protocol(s). For education, read this:
https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm
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