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  • We anticipate that the HDE initial review will take 75 days although FDA questions can result in additional review cycles, stated Mike Fritz, Synapse VP Clinical & Regulatory Affairs.Amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease, is a rapidly progressing, incurable and fatal neuromuscular disease characterized by progressive muscle weakness that results in par
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  • biospace.com