Means they are missing some pre clinical data and they have 2-3 months to resubmit and why AGN submitted it early before phase 2 read out to deal with these minor issues along the way. Could be a reason that they are in talks with China firms for a licensing agreement to fast track it there with a bigger market potential
Don’t like glutamate receptors, FDA never has
Ann: Update on Investigational New Drug Application, page-4
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