MAA/NDA is in the common technical document format - as you noted before, a format arrived by the International Committee on Harmonization. The eCTD is a document that builds from IND to P1 to P2 to P3 to MAA/NDA. All the bench and animal model tests, all the P1 information, all the P2 information...are all already in the eCTD. The CMC (chemistry, manufacturing, and controls) section is new - but the company said in the ASM last week that the CMC section is already complete. After all this time, it would be pretty shocking if the P3 data and analysis is not also complete. The OLE data and analysis still remains to be added, presumably. It is hard to imagine what else could be the hold up except for the EMA MAA timeline requirements and scheduling issues.
Still, I guess it is possible the the OLE data and analysis could take a very long time. The P3 data and analysis did... OTOH, if they are getting the data as patients finish then may they have all the JMP (or whatever tool they use) analysis and reports organized and will be able to finish swiftly. If there is MRI data, too, then if they are getting that info dribbling in then they should have been able to get nearly all but the last patient's MRIs analyzed and characterized.
I am pretty excited about 2-73 and 3-71...but also frustrated that, even by slow pharma standards, Anavex is extremely slow to execute.
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