EMA Timeline
I've been digging into the EU regulatory process to figure out our timeline. It's going to take a while.
Anavex announced they had initiated the European process by submitting a Centralised Process request, i.e., an EU-wide approach. Per protocol, this is done seven months before the submittal to the EMA.
Anavex has provided interim OLE data with the CP request. Seven months from now is June 2024; the OLE will have just completed by then. It appears to me that the OLE is providing critical, supplemental support to the 2b/3 AD trial. Clearly, it will provide more safety information, but I think it will also fill the gap in the ADL measure as well as likely documenting strengthening clinical effects over time.
(I expect a very similar approach with the FDA. Anavex is likely waiting on the OLE study to conclude before submitting its NDA application in roughly June 2024.)
The EU's CP process, post-application, will take more than a year. Although the EMA gets up to 210 days for its consideration, it may toll the process at a couple of points. And the 210 days are not calendar days -- they are "active" days, which I interpret as workdays. In other words, 42 weeks exclusive of holidays. And then the EU commission gets its own 67, presumably "active," days; another three months to consider the EMA recommendation.
In all, from CP submission to final decision can take about 13 months. That is, until July 2025. By that time we can expect the FDA to have made its decision a few months previously. I can now see why we have first heard about Europe. And the significance of the interim OLE results has become very apparent. They must be promising.
