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With a tally of 17-1, the advisory committee (adcomm) determined that there was not substantial evidence that NurOwn, a cell therapy made up of mesenchymal stromal cells secreting neurotrophic factors (MSC-NTF), was an effective treatment for patients with mild to moderate ALS

The number of paw withdrawal reactions was recorded during these ten experiments, and the percentage of reactions was calculated as: (number of paw lifts)/(total trials [ n = 10]) 100%

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16 This statement recommended that sponsors demonstrate the safety of their products for patients with cardiovascular (CV) disease, as most phase II and III trials excluded such patients