Anavex Life Sciences Corp (AVXL)

[Talon38]

Rett Syndrome. org updated their "Clinical Research" web page and while nothing has changed for 2-73, the following update was given for the start of the Neuren P3 for "trofinetide". With the possible delay, Anavex may be able slide the P2 of 2-73 in between Nueren's P2 and P3. As you remember, Nueren's positive results in their P2 trial was based on subjective care giver surveys. CM talked about using genome analysis to make the Rett Syndrome trial more effective. Nueren may be scrambling to do deeper analysis in order to shore up its P3 submission. CM may have executed a slick passing maneuver.

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Neuren Update RE: trofinetide
2-5-18
During our inaugural RettEd webinar on January 30, listeners submitted a question about the timing of trofinetide’s Phase 3 clinical trial. Thanks to Dr. Percy for his discussion of a possible late 2018 or early 2019 launch. We reached out to Neuren for a timeline update and want to share their response.
“Neuren has not yet confirmed the timeline, but there is a huge amount of preparation underway by Neuren and others to get ready for the trial, which is larger, longer and more complex than the previous two studies. Things are moving along nicely, but many different aspects have to be perfect before the trial starts, including approval of the protocol, manufacturing, trial sites, and logistics. All of these aspects are being worked on. Neuren will provide further updates in due course.” Jon Pilcher, CFO & Company Secretary, Neuren Pharmaceuticals
Rettsyndrome.org does not influence the timing of the Phase 3 launch. There are many behind the scenes activities taking place to ensure a successful trial. We are waiting in anticipation just as you are and will keep you updated with the latest timing information. RettEd webinars are a great way to say informed. For more information visit https://www.rettsyndrome.org/RettEd