It feels like all this time NWBO has been trying to do an end run around the approval system.
They've put all their eggs in this one leaky basket.
While risky they could have spent way less money and time by completing the trial on the 232nd event and began a new 2.5 - 3yr trial. They could have argued the OS of the original trial in court and public opinion. The new trial could have served as a confirmatory trial.
They didn't even have to wait for the 232nd event of this trial to start a new one.
Marz, out of the 6 endpoints, the sticky one is the PFS. LL said in her UAB talk on November 6th that for the patients, after a period of 3 to 6 months, there was no progression. Let us see how they explain the PFS situation in their paper.
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