I am hoping that you have misunderstood what Neu management "told" you LitteT.
To me it is incomprehensible that the trial sponsor is able to unlock the data base, gain access to the unblinded data, then perform their own statistical analysis.
Talk about putting Dracula in charge of the Blood Bank.
IMO - WON'T HAPPEN, because that ain't the way it goes. Nothing to do with the FDA either. All of the above is rightly the province of an independent statistician.
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