Regulatory Flexibility: BrainStorm’s Problematic NurOwn BLA May Be A Bridge Too Far For US FDA

30 Sep 2023

Litany of deficiencies, including product quality shortcomings and a failed Phase III clinical efficacy study, may make it impossible for the agency to exercise the type of flexibility it has with the approval of other treatments for ALS and neurodegenerative diseases.

Separate ways — The litany of problems with NurOwn may force the FDA to take a different path than it has with recently approved ALS drugs. • Source: Shutterstock

Regulatory Flexibility: BrainStorm’s Problematic NurOwn BLA May Be A Bridge Too Far For US FDA

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