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BioPharmaceutical United States Advisory Committees

FDA Hears Mixed Message On Feasibility, Need For Orkambi Vs. Kalydeco Trial

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Executive Summary

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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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