AA oncology NMEs are safe and effective, although development times are not accelerated. A return to endorsing phase II trial designs for AA for oncology NMEs, particularly for orphan drug indications, may facilitate timely FDA approval of novel cancer drugs.

Since its introduction in

Naga Chalasani has ongoing consulting activities (or had in preceding 12 months) with NuSirt, Abbvie, Allergan (Tobira), Madrigal, Siemens, Foresite, Genentech, Axcella, Zydus, and Galectin. Dr. Chalasani receives research grant support from Intercept, Galectin Therapeutics and Exact Sciences where his institution receives the funding.

No abstract