GAITHERSBURG, Md. – The de novo application by Neuronix Ltd., of Yokneam, Israel, proceeded to a March 21 FDA advisory committee with quite a lift in front of it, given that the treatment for mild to moderate Alzheimer's-type dementia failed to distinguish itself from sham treatment in the pivotal study. While the panelists were clearly moved by patient and caregiver testimony at the hearing, the fact that the pivotal study numerically favored the sham treatment doomed the application, even though the panelists nearly unanimously indicated that they saw a beneficial treatment effect. Read More
