Rochester was managing the Reach2HD trial. Their students were responsible for inputting all the information into the database. It could have been something as simple as a date/month/year - month/date/year mix up. We will likely never know.
From the Prana PR "There has been a delay in finalising the database to achieve ‘database lock’, required before statistical analysis of the data may begin."
“Apart from the timing delay, which is disappointing, nothing has changed. The trial was conducted and completed to protocol, and will provide the robust data needed to meet with the FDA in 2014 as we prepare for the next PBT2 trial,” said Geoffrey Kempler, Chairman and Chief Executive Officer.
From this you can infer that everything at the trial locations was done correctly. That only leaves the University to be at fault.
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