Lipocine Inc.

Discussion in 'Men's Economics' started by Michael Scally MD, Nov 4, 2013.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA
    Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA - Nov 11, 2019

    Shares of Lipocine Inc. LPCN, -77.29% plummeted 67% toward a record low, and to pace all premarket losers, after the biopharmaceutical company said the Food and Drug Administration indicated that its New Drug Application (NDA) for its testosterone deficiency treatment can't be approved in its present form.

    SALT LAKE CITY, Nov. 11, 2019 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced today that it has received a Complete Response Letter ("CRL") from the United States Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for TLANDO™, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.

    The CRL identified one deficiency stating the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations ("Cmax"). The CRL does not identify any specific issues relating to the chemistry, manufacturing and controls ("CMC") of TLANDO.
     
  2. Nissan

    Nissan Member

    They should just give up!
    This is the third nay from FDA for TLANDO!
     
    Michael Scally MD likes this.