FDA Hears Mixed Message On Feasibility, Need For Orkambi Vs. Kalydeco Trial
Some experts say a study in CF patients with the 508del mutation could not pass IRB muster, but others see an opportunity to answer the question of whether two drugs are needed or one will suffice.
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Phase III study in newly diagnosed patients with NPM1-mutated AML could enable Kronos’ SYK-inhibitor to reach market two years earlier under accelerated approval than it would under a traditional endpoint, company says.
Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.