Replies to post #390952 on Anavex Life Sciences Corp (AVXL)

[JKS3]

That's where SPA (agreement with FDA and other regulatory authorities) comes in. In a SPA, the company (say Anavex) negotiates with FDA to specify the primary endpoints and secondary endpoints. If there is no SPA, primary endpoints can be changed as a company wishes. When the agreed benchmarks are reached under a SPA, FDA will accept an NDA. FDA will consider drugs not under a SPA (273). The process is just very long and may require a more "experienced" partner.