re; CLDX phase III strategies
Bladerunner, in the absence of any combo dosing study, they might have to continue on monotherapy development path. It's a matter of how confident the management feels about data from these subsets.
Should they choose a two-arm phase III study, investigator's choice could certainly be an option in a less heavily treated population, and they might want to wait for matured PFS data to help size the study.
I would much prefer a placebo controlled phase III in late line setting when patients have exhausted all treatment options, although this might go against the philosophy of moving to earlier lines.
Should they choose a single-arm study with biomarker enrichment, then they would have to choose the subset and negotiate with FDA on an approvable clinically meaningful response rate (confirmed) in the late line setting in which their responders came from. And you are right they probably wouldn't have any trouble with recruitment although it might take longer to enroll due to a more narrow biomarker selected patient pool.
All this will take some time, it's not surprising in hindsight a few days ago CMO was quoted as saying to have begun to look for CRO partner and the phase III is at least a 7-9 months away. That sounds about right considering that they would need to get mature PFS data, get together the briefing document and go through the end of phase II meeting, and the SPA iteration.
Just my 2 cents.
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