I believe the NIH is responsible for the Clinical Trials database, I suspect that they speak with the FDA all the time and I feel reasonably confident that they verified what was stated before they published it.
Many months ago, before the trial was locked the FDA would have been given the SAP that contained the changes in the goals of the trial, they very probably had the reasons those changes needed to be made well documented. The FDA may not have produced a formal acceptance, but many things are done with the FDA in which a submittal is made to them and deemed to be accepted if the FDA doesn't have comments or questions within a specific number of days. It's considered a presumptive approval.
I believe that much the same is true when a company wishes to begin a trial, they file an IND and after so many days they may proceed, once again the NIH would place the trial in the Clinical Trials database. Can the FDA change things after a presumptive approval, certainly, they consider themselves G-D's and G-D's can do anything they wish, but who's going to complain about anything they do when they know they will also be the judge and jury as to whether their product is approved in the end. Don't get the idea that only tiny biotech's are pushed around by the FDA, on occasion they're every bit as bad with BP's.
Gary
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