Tag archive for ‘Xyosted CRL’
Antares: Things Are Looking Up (ATRS, Buy, $2.22)
Overview of Report I listened to the presentation by CEO Bob Apple at the Raymond James conference on March 5th and go over his key remarks in this report I have been frustrated by the CRL for Xyosted and delays in approval for AB rated versions of EpiPen and Byetta which have had a sharply […]
Antares: Approval of Xyosted is a Matter of When, Not If (ATRS, $2.12, Buy)
The Issue Antares received a complete response letter for Xyosted that did not cite any questions relating to efficacy, manufacturing, quality control or the device used to deliver testosterone. Surprisingly, the FDA raised concerns that Xyosted could cause a clinically meaningful increase in blood pressure and might also be linked to depression and suicidality. Let […]