Tag archive for ‘FDA accepts NDA resubmission as complete’
Antares Pharma: Approval of Xyosted on or before September 29, 2018 Is Highly Probable (ATRS, Buy, $2.12)
Background on Xyosted NDA Resubmission Following Complete Response Letter The original PDUFA date for the Xyosted NDA was October 20, 2017, but Antares received a complete response letter (CRL) on October 11, 2017 which shocked management and investors. Just days earlier management had said that the FDA review was progressing smoothly and that they were […]