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
Peptide Forums (GHRH, Sermorelin, etc)
General Peptide Use & Information
Tailor Made Compounding
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="Cataceous" data-source="post: 170181" data-attributes="member: 38109"><p>Basically. Repros was seeking FDA approval for enclomiphene under the name Androxal.</p><p></p><p style="margin-left: 20px"><em>"In December 2015, Repros Therapeutics Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application for enclomiphene. The FDA stated that, based on recent scientific developments, the design of enclomiphene Phase 3 studies was no longer adequate to demonstrate clinical benefit and <strong>recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population</strong>. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program."</em>[<a href="https://www.drugs.com/history/androxal.html" target="_blank">1</a>]</p><p></p><p>But asking for more studies was too much.</p><p></p><p style="margin-left: 20px"><em>Repros was among the first to feel the change of regulatory attitudes with the 2015 rejection of Androxal. That ailing biotech shifted focus for uterine fibroid therapy and was bought out last month by Allergan at 67 cents a share.</em>[<a href="https://endpts.com/the-fda-still-hates-low-t-drugs-experts-bat-back-a-pair-of-contenders/" target="_blank">2</a>]</p><p></p><p>Enclomiphene is on the market, but not as an FDA-approved drug. We explored how this is possible in one of the other enclomiphene threads.</p></blockquote><p></p>
[QUOTE="Cataceous, post: 170181, member: 38109"] Basically. Repros was seeking FDA approval for enclomiphene under the name Androxal. [INDENT][I]"In December 2015, Repros Therapeutics Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application for enclomiphene. The FDA stated that, based on recent scientific developments, the design of enclomiphene Phase 3 studies was no longer adequate to demonstrate clinical benefit and [B]recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population[/B]. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program."[/I][[URL='https://www.drugs.com/history/androxal.html']1[/URL]][/INDENT] But asking for more studies was too much. [INDENT][I]Repros was among the first to feel the change of regulatory attitudes with the 2015 rejection of Androxal. That ailing biotech shifted focus for uterine fibroid therapy and was bought out last month by Allergan at 67 cents a share.[/I][[URL='https://endpts.com/the-fda-still-hates-low-t-drugs-experts-bat-back-a-pair-of-contenders/']2[/URL]][/INDENT] Enclomiphene is on the market, but not as an FDA-approved drug. We explored how this is possible in one of the other enclomiphene threads. [/QUOTE]
Insert quotes…
Verification
Post reply
Share this page
Facebook
Twitter
Reddit
Pinterest
Tumblr
WhatsApp
Email
Share
Link
Sponsors
Forums
Peptide Forums (GHRH, Sermorelin, etc)
General Peptide Use & Information
Tailor Made Compounding
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