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Posted On: 04/06/2019 1:38:34 PM
Post# of 150042
So, granted that leronlimab's safety in combination with SOC chemotherapy is proven and that the excellent pre-clinical results in the secondary/substitute endpoint of reduction of CTC levels are confirmed during the phase1b/2 study: what is the time frame of the study/approval process? Will the FDA want to see safety and efficacy in the CTC endpoint for e.g. only 3 months, or rather for 6,9,12... months before giving green light for accelerated approval?
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