FDA votes against Lipocine’s TLANDO

Lipocine announces FDA voted 13-6 against TLANDO

Lipocine announces FDA voted 13-6 against TLANDO. Stockwinners.com
Lipocine announces FDA voted 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.


STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Leave a Reply

Your email address will not be published. Required fields are marked *