Posted by Lamdage22 on November 1, 2014, at 4:17:40
In reply to Re: The worst thing is being at other peoples mercy., posted by Lamdage22 on November 1, 2014, at 3:52:28
Thank you for your continued interest. As you are aware, Naurex is currently conducting early-stage clinical studies of GLYX-13 and NRX-1074 for the treatment of depression. The results of our initial studies have been positive and we have received Fast Track designation from the FDA for GLYX-13. However, as with any prescription medications, thorough evaluations of safety and efficacy are necessary before seeking approval from regulatory authorities to market our drugs. These studies will take significant time and we do not anticipate the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for GLYX-13 until 2018 at the earliest. An NDA for NRX-1074 could follow a few years later. Applications for approval will likely be submitted in the U.S. first, followed by other regions (including Germany).
That said, the development path will depend on the results of additional studies, discussions with regulatory authorities, and discussions with potential development partners. As such, the timing of the submission of an application for regulatory approval of GLYX-13 or NRX-1074 is uncertain and difficult to predict.
We hope that both GLYX-13 and NRX-1074 will be meaningful therapies for patients with depression and other psychiatric disorders and are working hard to achieve that goal as rapidly and responsibly as possible.
Best regards,
Naurex Inc.Schizo-Affective, type depressive
Seroquel 800mg
Zyprexa 2.5mg
Lithium orotate 480mg
Metformin 1500mg
Effexor 20mg
Please keep conspiracy theories to yourself!
poster:Lamdage22
thread:1073015
URL: http://www.dr-bob.org/babble/social/20141012/msgs/1073075.html