Neuralstem CEO Comments on Challenges of Drug Approval Process

Neuralstem Inc. just wrapped up their Phase I clinical trial testing the safety of injecting their human spinal cord neural stem cells (NSI-566) directly into the spinal cord for the treatment of ALS. Neuralstem is eager to start a Phase II study so they can get their stem cell therapy to ALS patients as soon as possible. In fact, they have already secured funding for the Phase II trial. Recently, Richard Garr, Neuralstem’s CEO, wrote a blog post where he commented on the stark contrast between the FDA’s “institutional” drug approval process, and the immediate urgency of patients to have access to drug options. Mr. Garr commented in his blog, “It is too easy to lose sight of the human cost from this disease in these institutional settings.” To read Garr’s provocative blog post, click here.

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