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news.Neuralstem, a biotechnology company, has announced that its spinal cord stem cell trial to treat amyotrophic lateral sclerosis is on clinical hold and that the FDA has provided the company with specific comments, questions and recommendations for modifications to its protocol.
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Richard Garr, president and CEO of Neuralstem, said: “The FDA has presented us with their review of our entire investigational new drug application. They have asked for some additional information regarding our product manufacturing process and preclinical studies, as well as our novel clinical delivery injection device and technique. The company believes that it can provide this information in an expeditious manner.”