Potential Regulatory Advantages
Since the active ingredient in ReViVox® is a small molecule with a known safety record in humans and well-understood mechanisms of action, DelNova anticipates that it will be allowed to pursue FDA approval via an accelerated 505(b)2 pathway.
Demonstrated Efficacy in Muscle
DelNova has shown in nonclinical studies, that the anticholinesterase is effective in recovering muscle activity in both classes of muscle, including skeletal muscle and smooth muscle. This broad applicability may be directed at improving outcomes for patients across a broad range of therapeutic indications.