Antares Pharma, Inc. (ATRS)

[hyperopia]

Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA

https://www.prnewswire.com/news-releases/lipocine-receives-complete-response-letter-for-tlando-from-us-fda-300955195.html

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.

"We are disappointed by the FDA's decision and intend to request a meeting with the FDA as soon as possible to discuss a potential path forward for the approval of TLANDO," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.


I thought there was a decent chance this could happen. Only one deficiency this time. Looks like Antares will have some more time to build market share . . .