Replies to post #437701 on Anavex Life Sciences Corp (AVXL)

[boi568]

From your own recitation, a SPA is not a requirement for a clinical trial. It is akin to technical assistance being offered by the FDA to companies intending to submit an NDA. As such, as I wrote previously, it will be most useful to companies in need of such assistance, apparently including SAVA. Companies that already know how design trials without FDA help will not need this form of technical assistance.

[Doc328]

Neuren/Acadia had an SPA for trofinetide in Rett and had agreed upon entry criteria, endpoints, method of analysis, and n -- this led to smooth sailing for the NDA and approval after their successful P3 . AVXL stated in June they will be using the same endpoints/method of analysis that Neuren had worked out with the FDA in their SPA. So if Missling doesn't go off script again, AVXL has a clear path --- assuming significance is reached and assuming the FDA is cool with the lower n. .