mdunbar
$FTH
• ORR is well below the 80% from Phase 1b. Some drop was expected, but the market priced in more than this.
• Single-arm trial: you can't separate the drug's effect from weekly paclitaxel, which produces responses on its own.
• PFS is immature. 16 patients are still on treatment, so the median could move either way.
• The 44% PIK3CA-mutant subgroup is probably small, and its size isn't given. Treat it as a hypothesis.
• "Phase 3, subject to regulatory alignment" suggests no accelerated-approval filing from this data. A randomized Phase 3 against chemo is expensive. With about $175M in cash, expect a partnership or a stock offering.
1
2