Cassava Sciences Inc. it has reached agreement with the U.S. Food and Drug Administration under a special protocol assessment for both of its pivotal Phase 3 studies of oral simufilam for the treatment of patients with Alzheimer's disease.
The company said these SPA agreements document that the FDA has reviewed and agreed upon the key design features of Cassava Sciences' Phase 3 study protocols of simufilam for the treatment of patients with Alzheimer's disease.
Cassava Sciences also reaffirmed prior guidance to advance simufilam into a Phase 3 pivotal program in Alzheimer's disease in fall 2021.
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