Wednesday, December 14, 2016 4:00:33 PM
Quick Shot Testosterone Update
Antares announced on September 22 that it had completed the QST-005 safety study for QuickShot Testosterone (QST). The conclusion of this supplemental safety study completes the clinical work necessary to begin the NDA submission process. Antares is on track to file an NDA in 4Q, 2016. The press release listed side effects seen in the study which appear to be consistent with testosterone replacement therapy and should satisfy the FDA on safety issues. I am projecting an NDA filing on January 1, 2017. I expect a ten month review which would lead to approval on November 1, 2017 followed by a launch on January 1, 2018. Hopefully, these are conservative estimates.
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