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Re: MinnieM post# 204662

Thursday, 11/23/2017 10:51:52 AM

Thursday, November 23, 2017 10:51:52 AM

Post# of 402582
OM trial history is a bit more complicated. Originally recruitment was to start Jan-2015, and the last follow-up date was Dec-2016. But, the start got delayed by 6 months, which pushed the original estimate for the last follow-up to mid-2017. Then towards the end of 2016 OM trial runners got a better feel on recruitment rate and it must have become obvious that the trial will not complete in estimated time, hence the date for the last follow-up was changed to Dec-2017.

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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