ExcelMale
Menu
Home
What's new
Latest activity
Forums
New posts
Search forums
What's new
New posts
Latest activity
Videos
Lab Tests
Doctor Finder
Buy Books
About Us
Men’s Health Coaching
Log in
Register
What's new
Search
Search
Search titles only
By:
New posts
Search forums
Menu
Log in
Register
Navigation
Install the app
Install
More options
Contact us
Close Menu
Forums
Testosterone Replacement, Low T, HCG, & Beyond
Clomid for PCT, fertility or low T
Why Clomid Fails: The Zuclomiphene Threshold
JavaScript is disabled. For a better experience, please enable JavaScript in your browser before proceeding.
You are using an out of date browser. It may not display this or other websites correctly.
You should upgrade or use an
alternative browser
.
Reply to thread
Message
<blockquote data-quote="Nelson Vergel" data-source="post: 37975" data-attributes="member: 3"><p>The FDA has not declined approval of Androxal yet. They are asking for more data. I am actually happy they did.</p><p></p><p>February 8, 2016</p><p></p><p><strong>Repros Holds Meeting With FDA to Discuss Complete Response Letter for Enclomiphene in the Treatment of Secondary Hypogonadism</strong>THE WOODLANDS, Texas, Feb. 08, 2016 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that on February 4, 2016, the Company attended a productive meeting with FDA reviewers and senior leaders to discuss resolution of issues identified during the enclomiphene NDA review. The meeting agenda covered a broad range of topics surrounding the NDA data as well as emerging Agency and expert thinking regarding the treatment of hypogonadism. The Company believes that it was clear during the meeting that the FDA is not closed to entertaining secondary hypogonadism as an indication.</p><p></p><p>January 4, 2016</p><p></p><p><strong>Repros Updates Enclomiphene Program</strong><em>Repros expects to meet with FDA to discuss "Complete Response Letter" for enclomiphene NDA during February 2016</em></p><p><em>Marketing Authorization Application (MAA) for enclomiphene planned for submission in Europe mid-2016</em></p><p>THE WOODLANDS, Texas, Jan. 04, 2016 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has been granted a meeting with the Division of Bone, Reproductive and Urologic Products (DBRUP) of the FDA to discuss aspects of the "Complete Response Letter" received on Nov. 30, 2015 for the enclomiphene NDA. The meeting will be held during February 2016.</p><p><em>European MAA</em></p><p>The Company plans a central filing in Europe for an indication of enclomiphene for the treatment of secondary hypogonadism. The remaining item on the critical path to the submission is manufacture of finished drug product in Europe meeting EU requirements. The Company believes the MAA will be submitted mid-2016. The review cycle for a central filing is 17 months.</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 37975, member: 3"] The FDA has not declined approval of Androxal yet. They are asking for more data. I am actually happy they did. February 8, 2016 [b]Repros Holds Meeting With FDA to Discuss Complete Response Letter for Enclomiphene in the Treatment of Secondary Hypogonadism[/b]THE WOODLANDS, Texas, Feb. 08, 2016 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that on February 4, 2016, the Company attended a productive meeting with FDA reviewers and senior leaders to discuss resolution of issues identified during the enclomiphene NDA review. The meeting agenda covered a broad range of topics surrounding the NDA data as well as emerging Agency and expert thinking regarding the treatment of hypogonadism. The Company believes that it was clear during the meeting that the FDA is not closed to entertaining secondary hypogonadism as an indication. January 4, 2016 [b]Repros Updates Enclomiphene Program[/b][I]Repros expects to meet with FDA to discuss "Complete Response Letter" for enclomiphene NDA during February 2016[/I] [I]Marketing Authorization Application (MAA) for enclomiphene planned for submission in Europe mid-2016[/I] THE WOODLANDS, Texas, Jan. 04, 2016 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has been granted a meeting with the Division of Bone, Reproductive and Urologic Products (DBRUP) of the FDA to discuss aspects of the "Complete Response Letter" received on Nov. 30, 2015 for the enclomiphene NDA. The meeting will be held during February 2016. [I]European MAA[/I] The Company plans a central filing in Europe for an indication of enclomiphene for the treatment of secondary hypogonadism. The remaining item on the critical path to the submission is manufacture of finished drug product in Europe meeting EU requirements. The Company believes the MAA will be submitted mid-2016. The review cycle for a central filing is 17 months. [/QUOTE]
Insert quotes…
Verification
Post reply
Share this page
Facebook
Twitter
Reddit
Pinterest
Tumblr
WhatsApp
Email
Share
Link
Sponsors
Forums
Testosterone Replacement, Low T, HCG, & Beyond
Clomid for PCT, fertility or low T
Why Clomid Fails: The Zuclomiphene Threshold
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to our use of cookies.
Accept
Learn more…
Top