Lipocine Inc (LPCN)

[gi197845]

Yes, that's interesting, so what's your take on it?

U.S. FDA Denies Claruss Oral Testosterone Ester Citizen Petition
8:00 AM ET 4/17/20 | Dow Jones

SALT LAKE CITY, April 17, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States Food and Drug Administration ("FDA") denied the Citizen Petition filed by Clarus Therapeutics Inc. ("Clarus") on October 2, 2019. Specifically, the FDA declined to issue product-specific guidance on oral T-ester drug products and denied without comment Clarus' request regarding how the FDA should review and make approval decisions on any pending or future oral T-ester products.

Clarus originally filed the Citizens Petition with the FDA requesting the FDA issue "clear, written guidance regarding the safety and efficacy standards required for oral testosterone-ester prodrugs as testosterone replacement therapy" and requested the FDA not to approve "any pending [new drug application ("NDA")] for an oral T-ester to treat male hypogonadism that fails to meet the standards for approval set forth in [the] petition."