Wednesday, July 20, 2016

FDA accepts SCENESSE® clinical data package for NDA submission

FDA accepts SCENESSE® clinical data package for NDA submission
Clinuvel prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP) Executive summary: FDA concludes initial review of datasets on SCENESSE® in EPP FDA deems datasets satisfactory for submission of New Drug Application Pre-NDA meeting with FDA to be scheduled to discuss timelines and procedure Clinuvel will request rolling review of NDA under Fast Track designation Clinuvel to request Priority Review to shorten review from 10 to 6 months Clinuvel Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that the US Food and Drug Administration (FDA) has concluded an initial review of Clinuvel's clinical...

You may view the full Clinuvel announcement here:

This is great news for the EPP community!  We are on our way to approval of Scenesse/Afamelanotide.  Be sure to register to attend the FDA meeting to join us in our continued efforts to show the FDA how important it is for them to approve this drug in the US.
Date:            Monday, October 24th, 2016
Time:           10 am - 4 pm
Location:     FDA White Oak Campus
                      10903 New Hampshire Ave.
                      Building 31, Great Room
                      Silver Spring, MD 20993

*After you register, you will receive a confirmation email from the FDA with various questions to answer.*

PLEASE let the APF know you will be attending once you have finished registering online.  We will be hosting a gathering for everyone the evening before the meeting.  You may call the office at 866-APF-3635 or email us at

*Please note that if you are unable to attend in person, there is an option for you to attend via webcast.*

"Remember....Research is the key to your cure!"

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