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Lipocine SOARS on oral testosterone data despite FDA concerns

This article was originally published in Scrip

Executive Summary

Top-line results from the pivotal Phase III SOAR trial of Lipocine's oral testosterone product LPCN 1021 in hypogonadal men with low testosterone (Low T) show that it met its primary endpoint of getting serum hormone levels back to normal. Lipocine expects to file a new drug application (NDA) with the US FDA in the second half of 2015.

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