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Posted On: 02/07/2020 10:26:55 AM
Post# of 154912
Re: generactor #17356
Thanks for this.
CTC levels are the secondary endpoint which is supposed to serve as a surrogate endpoint for accelerated approval; Phase 4 study would be done to confirm that reduction below <5 indicates longer PFS and OS, which is statistically likely, espeially if at 0.
With CTC levels at 0 and shrinkage of primary tumour, it seems reasonably likely that FDA will grant AA if we show them good enough data from enough patients.
CTC levels are the secondary endpoint which is supposed to serve as a surrogate endpoint for accelerated approval; Phase 4 study would be done to confirm that reduction below <5 indicates longer PFS and OS, which is statistically likely, espeially if at 0.
With CTC levels at 0 and shrinkage of primary tumour, it seems reasonably likely that FDA will grant AA if we show them good enough data from enough patients.
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