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What up? DXB- no other way.., page-3

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    Hi Ahmed, nice to have you back. Did you read the Retrophin phonecall transcript? Looks like they have pushed out the start of their phase 3 Sparsentan trial until at least the end of the year now, once they have spoken to the FDA again....

    Steve Aselage
    Thanks Chris. Good afternoon everyone and thank you for joining us on today's call. We reached important milestones in the first quarter which have kept us on course to deliver sustainable value in 2017, and the years ahead. Perhaps most importantly, we made solid progress with Sparsentan and RE-024. These programs from our pipeline have great opportunities to make meaningful differences in the lives of people living with FSGS and with PKAN. Based on our End of Phase 2 meeting with the FDA during the quarter, we gained regulatory clarity on a path to approval for Sparsentan in FSGS. Specifically, FDA agreed on an outline of a single Phase 3 trial to enable an NDA filing.
    Our Research & Development team is working diligently to develop a protocol that positions the trial for success at both the interim and confirmatory readouts of this study. We are working to define the optimal statistical model that will allow us to design the most robust protocol. Once we have gotten that piece of the statistical analysis set, we'll go back to confirm alignment with the FDA in the second half of this year with the intention of initiating the trial around the end of the year. We still have a bit of work to go, but I'm pleased with the progress to date, and look forward to updating you as we get closer to those milestones.


    https://seekingalpha.com/article/40...lage-q1-2017-results-earnings-call-transcript
 
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