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Lipocine's Regulatory Hiccups Continue: Testosterone Drug Issued Complete Response Letter, Stock Tanks

Lipocine's Regulatory Hiccups Continue: Testosterone Drug Issued Complete Response Letter, Stock Tanks

Lipocine Inc (NASDAQ: LPCN) stock is poised to lose about one-third of its market value Wednesday, as its Tlando was handed a complete response letter from the FDA for a second time.

The shares were plunging 35 percent at the time of publication.

What Happened

Lipocine announced Wednesday ahead of the market open the FDA issued a CRL for its new drug application for Tlando, its testosterone replacement therapy intended to treat hypogonadism.

A CRL is a communication from the FDA that an application cannot be approved in its present form.

The FDA indicated four deficiencies: confirming the reliability of T data, obtaining definitive pre-approval evidence, verifying reliability of Cmax secondary endpoints of Tlando and determining appropriate stopping criteria.

It is to be noted that FDA's Bone, Reproductive and Urologic Drugs Advisory Committee, which met in January, voted 13-6 against the benefit-risk profile of Tlando.

Why It's Important

The CRL is likely to hurt Lipocine, as of its three pipeline candidates, Tlando is in the most advanced stage of development.

The regulatory path for this testosterone replacement therapy has been rocky, as the FDA issued a CRL in June 2016 that requested additional information related to the dosing algorithm for the proposed label. Following a resubmission, the FDA accepted the application as a complete response in August 2017, and set a new PDUFA goal date of Feb. 8 — which was subsequently extended by three months.

What's Next

Lipocine said it is already cognizant of the deficiencies identified in the CRL following the meeting with the FDA panel in January.

"We are assessing the content of the CRL, including the information that may be needed to resolve the deficiencies," Chairman and President Dr. Mahesh Patel said in a statement. 

"We remain committed to work with the FDA to bring TLANDO to patients."

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