jto2
Oct 23, 11:00 PM
$CATX The CEO has repeatedly outlined the Phase 3 plan all year:
- Hundreds of patients enrolled at US sites, not a traditional trial enrolling thousands
- SSTR2-positive in all lesions
- Physician’s choice comparator
- PFS as the likely registration endpoint, with ORR potentially supporting an AA pathway
- 20 mCi based on Cohort 2; Cohort 4 is testing front-loading, not redefining the dose
My expectation is a Cohort 2-based AA pathway, followed by a Phase 3 confirmatory trial.
Today, management reiterated the year-end target for Phase 3 site activation. Trial design, site selection, contracts, and other preparations need to be finalized well in advance.
Given this timeline, an announcement clarifying the FDA registration trial design should be coming soon.
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