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PDUFA June 28 2016 of LPCN 1021 for men with low testosterone

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Additional Relevant Details PDUFA goal date of June 28, 2016 for completion of the review of the New Drug Application ("NDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone ("hypogonadism"). Additionally, the 74-day filing communication letter did not mention a need to convene an Advisory Committee for advice on the NDA for LPCN 1021 and we confirmed in subsequent communication with the FDA that an Advisory Committee is not planned.
Additional Relevant Details
"Our focus remains on evaluating the content of the CRL, including the FDA recommended actions, to bring our NDA for LPCN 1021 into a position for approval. We remain committed to bringing LPCN 1021 to patients who will benefit from its intended use," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine. "In addition, we continue to advance the progress of our other pipeline products, LPCN 1107 and LPCN 1111, with updates expected in the coming months."
Additional Relevant Details
The CRL identified deficiencies related to the dosing algorithm for the label. Specifically, the proposed titration scheme for clinical practice was significantly different from the titration scheme used in the Phase 3 trial leading to discordance in titration decisions between the Phase 3 trial and real-world clinical practice. The next step will be to request a meeting with the FDA to understand more fully the issues raised and to agree on a path forward to achieve approval of LPCN 1021.
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Catalyst Date
Occurred on:
Jun 29, 2016
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Related Keywords Pdufa, Lpcn 1021, Low Testosterone, Low-t, Nda, Trt, Testosterone Replacement Therapy, Hypogonadism