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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
ANDROXAL - Latest Update
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<blockquote data-quote="HarryCat" data-source="post: 26575" data-attributes="member: 856"><p>Looks like Androxal is in trouble:</p><p></p><p><a href="http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=939322" target="_blank"><strong>Repros Therapeutics Announces Cancellation of FDA Advisory Committee Meeting to Review Enclomiphene for the Treatment of Secondary Hypogonadism</strong></a></p><p></p><p>THE WOODLANDS, Texas, Oct. 29, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that the Division of Bone, Reproductive and Urologic Products of the U.S. Food and Drug Administration (FDA) has cancelled the scheduled November 3, 2015 advisory committee to review the Company's New Drug Application (NDA) for its enclomiphene product candidate, formerly known as Androxal®, due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data.</p><p>The FDA has expressed its willingness to work with Repros to address these questions. The FDA accepted the NDA for review on April 1, 2015 and later assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2015.</p></blockquote><p></p>
[QUOTE="HarryCat, post: 26575, member: 856"] Looks like Androxal is in trouble: [URL="http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=939322"][B]Repros Therapeutics Announces Cancellation of FDA Advisory Committee Meeting to Review Enclomiphene for the Treatment of Secondary Hypogonadism[/B][/URL] THE WOODLANDS, Texas, Oct. 29, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that the Division of Bone, Reproductive and Urologic Products of the U.S. Food and Drug Administration (FDA) has cancelled the scheduled November 3, 2015 advisory committee to review the Company's New Drug Application (NDA) for its enclomiphene product candidate, formerly known as Androxal®, due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data. The FDA has expressed its willingness to work with Repros to address these questions. The FDA accepted the NDA for review on April 1, 2015 and later assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2015. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
ANDROXAL - Latest Update
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