Sorry, this is poor trial management. 16 years for a 5 year duration trial?? FDA partial hold, 19 months from datalock to TLD release -- these are all like record slow times for a trial. They burned $1 Billion to do this. No BP would ever tolerate this trial mismanagement. And all that to toss out the whole protocol, endpoints, comparator and SAP!?!?!?! Man what a trainwreck from a trial design and management standpoint.
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