Lipocine announces FDA voted 13-6 against TLANDO
Lipocine (LPCN) announced that the Bone, Reproductive and Urologic Drugs Advisory Committee of the U.S. Food and Drug Administration voted six in favor and thirteen against the benefit/risk profile of TLANDO, the Company’s oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
The role of BRUDAC is to provide recommendations to the FDA.
The FDA decision on whether or not to approve the TLANDO New Drug Application is anticipated by the assigned Prescription Drug User Fee Act goal date of May 8, 2018.
CEO Mahesh Patel says: “We continue to believe that efficacy and safety results from numerous clinical studies with TLANDO are consistent with other FDA approved TRT products… We look forward to continuing to work with the FDA through the remainder of the review process.”
LPCN closed at $3.46.
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