The FDA did not demand NWBO take a dormant P2 that had.enrolled 17 patients not powered for OS and repurpose as a P3.
The trial design was all on NWBO.
It was NWBO that kept PFS as the primary despite what was seen with DNDN. It was NWBO that did not use IRANO to measure PFS so as to reduce false psPD.
On crossover, that is an issue all trials in the early oncology settings have to deal with. Once a patient progresses they will try other treatments. If a drug is truly effective it still should trend towards a benefit. DC L did not.I don't hear MRK crying whenever their CI fails a frontline trial with patients using CIs after progression.
And on, the gold standard is OS ina randomized setting. And that failed despite any attempts to spin it.
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