- The FDA agreed that the 505(b)2 pathway is acceptable for BHV-0223 in ALS.
- The FDA agreed that no additional efficacy or toxicology studies are necessary for submission of the NDA.
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Biohaven Announces Expedited Development Path for BHV-0223 Following Successful pre-IND Interaction with FDA
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Feb 25, 2016
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Related Keywords Zydis, Als, Alzheimer's Disease, Bhv-0223, Rett Syndrome, Dementia, Dystonia, Tinnitus, Anxiety Disorders, Catalent, Glutamate Modulating Agent, Riluzole