Early look??
The trial was designed (subsequent to the 2014 resize) to read out when 244 PFS events were reached which was something like 3-1/2 years ago. Even the OS secondary (which by design would be analyzed even after the unbind) was about 3 years ago.
More to the point, what right would FDA have to do this? If LP wants to run the trial and the FDA is pissed they can stop the trial. Hard to argue for that though when I think all agree the patients are well treated. But even then they have no right to force NWBO to disclose the blinded data. Even if LP wants to continue waiting there is nothing the FDA could do.
And worse, would you think the Health Canada or others could step in and force disclosure of US trial data?
Last, there are laws in place. The FDA can not approve (even accelerated) w/o the company saying what they want approved.
Sponsors run trials. The agencies insure they are reasonably safe and such, but do not directly run them as many around here think.
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