It looks straightforward on paper but:
1. Difficult disease, no local therapy (including RT) has shown convincing benefit (survival) in RCTs in this group
2. How long would the trial take ? (Let’s say it’s 300 as previously communicated by company)
3. your proposed control group of GNP - recently published LAPACT trial of this combination in LAPC appeared to outperform Panco (which used mostly background GNP) on survival, PFS, response. Resection rate lower in LAPACT trial but they excluded borderlines.
So Phase 3 will be challenging imo. At some point I’d be expecting OSL to inform market about the US trial design, hope to know more then.
It looks straightforward on paper but:1. Difficult disease, no...
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