Friday, February 08, 2019 9:54:28 AM
Because someone contacted me to ask this question ...he (Missling) is talking about the Neuren trial which is already been P3 approved by FDA and partnered up on. It's a 180 patient trial which the FDA apparently has told them if it met with the same stat significance as their P2, they will be able to file for their NDA out of their P3 trial which starts later this year with their partner. I believe they are using at least one of the metrics that Missling is referring to. Neuren is already well past the point of worrying about what age patients they can treat with the P2s they have run. Maybe Kauffman helped them to design their P3 trial as well and is now helping Anavex do the same? Either way just posting a link where you can find my take on that info. There may be more recent. I don't know. Just passing along. I don't have a dog in the fight either way or either company but seems they are well ahead of anavex in their clinical trials and partnerships. Doesn't mean they have the answer but they do have stat sig in P2 trials.
From Neuren's website.
http://www.neurenpharma.com/irm/PDF/1785_0/CantorFitzgeraldequityresearchonACADIAfeaturingtrofinetideandNeuren15October2018
From Neuren's website.
http://www.neurenpharma.com/irm/PDF/1785_0/CantorFitzgeraldequityresearchonACADIAfeaturingtrofinetideandNeuren15October2018
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