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Because of the new information , about 88% of patients developing elevated PD-L1 , and from those 100% who received ICI are improved or in sustain remission for about 5 years now. , they plan to do after the 12 months Rollover.

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Yes, due to the new information I would expect that the rollover protocol would most certainly be approved by FDA. And the patient would not need to wait 12 months to enter the rollover portion of the trial. Once patients progress, they have "completed" the initial trial and can commence in the extension.

I am hopeful that the main trial will be amended to allow patients to receive ICI as soon as PD-L1 levels are sufficient. Just not sure FDA will go for it...