As I understand it that does not give an absolute ability to file an NDA. What it does do is allow Anavex to have conversations with the FDA, present data to the FDA and request guidance on filing an NDA.
The FDA could say yes there is enough positive information there to go ahead with an NDA or the FDA could look at the data and say you need additional data go run another P3 with more subject or changes in the protocol.
Given the upgrading of the trial to P3 that suggests to me that the FDA is already happy with what data it has seen. So far we don't know if the FDA has seen the full data analysis of the trial.
The FDA may just be saying "We like what we see so far. Show us the full data analysis and we'll go from there."
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